<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02984982</url>
  </required_header>
  <id_info>
    <org_study_id>ALIROL08069</org_study_id>
    <secondary_id>U1111-1184-8764</secondary_id>
    <nct_id>NCT02984982</nct_id>
  </id_info>
  <brief_title>Evaluation of Effect of Alirocumab on Coronary Atheroma Volume in Japanese Patients Hospitalized for Acute Coronary Syndrome With Hypercholesterolemia</brief_title>
  <acronym>ODYSSEY J-IVUS</acronym>
  <official_title>A Randomized, Open-label, Blinded Intravascular Ultrasound Analysis, Parallel Group, Multicenter Study to Evaluate the Effect of Praluent® (Alirocumab) on Coronary Atheroma Volume in Japanese Patients Hospitalized for Acute Coronary Syndrome With Hypercholesterolemia Not Adequately Controlled With Statin</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sanofi</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Regeneron Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Sanofi</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Primary Objective:&#xD;
&#xD;
      To compare the efficacy of alirocumab (Praluent®) with standard of care (SoC) on coronary&#xD;
      atheroma progression (percent change in normalized total atheroma volume [TAV]) after 9&#xD;
      months of treatment in participants who had acute coronary syndrome (ACS) within 4 weeks&#xD;
      prior to randomization, with hypercholesterolemia treated with statin.&#xD;
&#xD;
      Secondary Objectives:&#xD;
&#xD;
        -  To compare the efficacy of alirocumab (Praluent®) with SoC on secondary endpoints&#xD;
           including absolute change in percent atheroma volume and normalized TAV after 9 months&#xD;
           of treatment.&#xD;
&#xD;
        -  To evaluate the efficacy of alirocumab (Praluent®) on low-density lipoprotein&#xD;
           cholesterol (LDL-C), apolipoprotein B, triglycerides, non-high-density lipoprotein&#xD;
           cholesterol and lipoprotein (a) after 9 months treatment.&#xD;
&#xD;
        -  To evaluate the safety of alirocumab (Praluent®) including the occurrence of&#xD;
           cardiovascular events (coronary heart disease death, non-fatal myocardial infarction,&#xD;
           fatal and non-fatal ischemic stroke, unstable angina requiring hospitalization)&#xD;
           throughout the study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The duration of study per participant was 9 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 15, 2016</start_date>
  <completion_date type="Actual">July 27, 2018</completion_date>
  <primary_completion_date type="Actual">July 27, 2018</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percent Change From Baseline in Normalized Total Atheroma Volume (TAV) at Week 36</measure>
    <time_frame>Baseline, Week 36</time_frame>
    <description>Least-squares (LS) means and standard errors (SE) at Week 36 were obtained from analysis of covariance (ANCOVA) model including treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]) as fixed categorical effects, and the baseline normalized TAV as continuous fixed covariate.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Absolute Change From Baseline in Percent Atheroma Volume (PAV) at Week 36</measure>
    <time_frame>Baseline, Week 36</time_frame>
    <description>LS mean and SE at Week 36 were obtained from ANCOVA model including treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]) as fixed categorical effects, and the baseline PAV as continuous fixed covariate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute Change From Baseline in Normalized Total Atheroma Volume at Week 36</measure>
    <time_frame>Baseline, Week 36</time_frame>
    <description>LS mean and SE at Week 36 were obtained from ANCOVA model including treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]) as fixed categorical effects, and the baseline normalized TAV as continuous fixed covariate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute Change From Baseline in External Elastic Membrane (EEM) Volume at Week 36</measure>
    <time_frame>Baseline, Week 36</time_frame>
    <description>Adjusted mean and SE at Week 36 were obtained from robust regression model with treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]), as fixed categorical effects, and the baseline EEM volume value as continuous fixed covariate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in External Elastic Membrane Volume at Week 36</measure>
    <time_frame>Baseline, Week 36</time_frame>
    <description>Adjusted mean and SE at Week 36 were obtained from robust regression model including treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]) as fixed categorical effects, and the baseline EEM volume value as continuous fixed covariate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute Change From Baseline in Lumen Volume at Week 36</measure>
    <time_frame>Baseline, Week 36</time_frame>
    <description>Adjusted mean and SE at Week 36 were obtained from robust regression model including treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]) as fixed categorical effects, and the baseline lumen volume value as continuous fixed covariate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Lumen Volume at Week 36</measure>
    <time_frame>Baseline, Week 36</time_frame>
    <description>Adjusted mean and SE at Week 36 were obtained from robust regression model including treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]) as fixed categorical effect, and the baseline lumen volume value as continuous fixed covariate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute Change From Baseline in Calculated Low-density Lipoprotein Cholesterol at Week 12 and Week 36</measure>
    <time_frame>Baseline, Week 12, Week 36</time_frame>
    <description>Adjusted LS mean and SE at Week 12 and Week 36 were obtained from mixed-effect model including all available post-baseline data from Week 4 to Week 36. Model included treatment arm (SoC arm, alirocumab arm), randomization strata (statin at ACS onset [Yes / No]), time point, treatment-by-time point and randomization strata-by-time point interaction as fixed categorical effects, and baseline calculated LDL-C value and baseline calculated LDL-C value-by-time point interaction as continuous fixed covariates.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Calculated Low-density Lipoprotein Cholesterol at Week 12 and Week 36</measure>
    <time_frame>Baseline, Week 12, Week 36</time_frame>
    <description>Adjusted LS mean and SE at Week 12 and Week 36 were obtained from mixed-effect model including all available post-baseline data from Week 4 to Week 36. Model included treatment arm (SoC arm, alirocumab arm), randomization strata (statin at ACS onset [Yes / No]), time point, treatment-by-time point and randomization strata-by-time point interaction as fixed categorical effects, and baseline calculated LDL-C value and baseline calculated LDL-C value-by-time point interaction as continuous fixed covariates.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute Change From Baseline in Apolipoprotein B (Apo B) at Week 36</measure>
    <time_frame>Baseline, Week 36</time_frame>
    <description>Adjusted LS mean and SE at Week 36 were obtained from ANCOVA model including treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]) as fixed categorical effects, and baseline Apo B value as continuous fixed covariate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Apolipoprotein B at Week 36</measure>
    <time_frame>Baseline, Week 36</time_frame>
    <description>Adjusted LS mean and SE at Week 36 were obtained from ANCOVA model including treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]) as fixed categorical effects, and baseline Apo B value as continuous fixed covariate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute Change From Baseline in Non-High-density Lipoprotein Cholesterol (Non-HDL-C) at Week 36</measure>
    <time_frame>Baseline, Week 36</time_frame>
    <description>Adjusted LS mean and SE at Week 36 were obtained from mixed-effect model including all available post-baseline data from Week 4 to Week 36. Model included treatment arm (SoC arm, alirocumab arm), randomization strata (statin at ACS onset [Yes / No]), time point, treatment-by-time point and randomization strata-by-time point interaction as fixed categorical effects, and baseline calculated non-HDL-C value and baseline calculated non-HDL-C value-by-time point interaction as continuous fixed covariates.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Non-High-density Lipoprotein Cholesterol at Week 36</measure>
    <time_frame>Baseline, Week 36</time_frame>
    <description>Adjusted LS mean and SE at Week 36 were obtained from mixed-effect model including all available post-baseline data from Week 4 to Week 36. Model included treatment arm (SoC arm, alirocumab arm), randomization strata (statin at ACS onset [Yes / No]), time point, treatment-by-time point and randomization strata-by-time point interaction as fixed categorical effects, and baseline calculated non-HDL-C value and baseline calculated non-HDL-C value-by-time point interaction as continuous fixed covariates.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute Change From Baseline in Total Cholesterol (TC) at Week 36</measure>
    <time_frame>Baseline, Week 36</time_frame>
    <description>LS mean and SE at Week 36 were obtained from mixed-effect model including all available post-baseline data from Week 4 to Week 36. Model included treatment arm (SoC arm, alirocumab arm), randomization strata (statin at ACS onset [Yes / No]), time point, treatment-by-time point and randomization strata-by-time point interaction as fixed categorical effects, and baseline calculated TC value and baseline calculated TC value-by-time point interaction as continuous fixed covariates.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Total Cholesterol at Week 36</measure>
    <time_frame>Baseline, Week 36</time_frame>
    <description>Adjusted LS mean and SE at Week 36 were obtained from mixed-effect model including all available post-baseline data from Week 4 to Week 36. Model included treatment arm (SoC arm, alirocumab arm), randomization strata (statin at ACS onset [Yes / No]), time point, treatment-by-time point and randomization strata-by-time point interaction as fixed categorical effects, and baseline TC value and baseline TC value-by-time point interaction as continuous fixed covariates.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute Change From Baseline in Lipoprotein (a) (Lp[a]) at Week 36</measure>
    <time_frame>Baseline, Week 36</time_frame>
    <description>Adjusted mean and SE at Week 36 were obtained from robust regression model including treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]) as fixed categorical effect, and baseline Lp(a) value as continuous fixed covariate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Lipoprotein (a) at Week 36</measure>
    <time_frame>Baseline, Week 36</time_frame>
    <description>Adjusted mean and SE at Week 36 were obtained from robust regression model including treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]) as fixed categorical effect, and baseline Lp(a) value as continuous fixed covariate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute Change From Baseline in High-density Lipoprotein Cholesterol at Week 36</measure>
    <time_frame>Baseline, Week 36</time_frame>
    <description>Adjusted LS mean and SE at Week 36 were obtained from mixed-effect model including all available post-baseline data from Week 4 to Week 36. Model included treatment arm (SoC arm, alirocumab arm), randomization strata (statin at ACS onset [Yes / No]), time point, treatment-by-time point and randomization strata-by-time point interaction as fixed categorical effects, and baseline HDL-C value and baseline HDL-C value-by-time point interaction as continuous fixed covariates.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in High-density Lipoprotein Cholesterol at Week 36</measure>
    <time_frame>Baseline, Week 36</time_frame>
    <description>Adjusted LS mean and SE at Week 36 were obtained from mixed-effect model including all available post-baseline data from Week 4 to Week 36. Model included treatment arm (SoC arm, alirocumab arm), randomization strata (statin at ACS onset [Yes / No]), time point, treatment-by-time point and randomization strata-by-time point interaction as fixed categorical effects, and baseline HDL-C value and baseline HDL-C value-by-time point interaction as continuous fixed covariates.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute Change From Baseline in Fasting Triglycerides (TGs) at Week 36</measure>
    <time_frame>Baseline, Week 36</time_frame>
    <description>Adjusted mean and SE were obtained from multiple imputation approach followed by robust regression model including fixed categorical effect of treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]) and the continuous fixed covariate of baseline fasting TGs value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Fasting Triglycerides at Week 36</measure>
    <time_frame>Baseline, Week 36</time_frame>
    <description>Adjusted mean and SE were obtained by multiple imputation approach followed by robust regression model included fixed categorical effect of treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]) and the continuous fixed covariate of baseline fasting TGs value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute Change From Baseline in Apolipoprotein A-1 (Apo A-1) at Week 36</measure>
    <time_frame>Baseline, Week 36</time_frame>
    <description>Adjusted LS mean and SE at Week 36 were obtained from ANCOVA model including treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]) as fixed categorical effects, and baseline Apo A-1 value as continuous fixed covariate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in Apolipoprotein A-1 at Week 36</measure>
    <time_frame>Baseline, Week 36</time_frame>
    <description>Adjusted LS mean and SE at Week 36 were obtained from ANCOVA model including treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]) as fixed categorical effects, and baseline Apo A-1 value as continuous fixed covariate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Cardiovascular (CV) Adverse Events</measure>
    <time_frame>Up to 36 weeks</time_frame>
    <description>The suspected or confirmed CV events that occurred from randomization until end of the study visit were collected and reported. The various CV events included CV death, myocardial infarction, ischemic stroke, unstable angina requiring hospitalization , congestive heart failure requiring hospitalization, congestive heart failure requiring hospitalization, ischemia-driven coronary revascularization procedure.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">206</enrollment>
  <condition>Hypercholesterolemia</condition>
  <condition>Acute Coronary Syndrome</condition>
  <arm_group>
    <arm_group_label>Standard of Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Statin therapy (atorvastatin or rosuvastatin) will be administered with or without non-statin lipid modifying therapies (LMTs). Non-statin LMTs will be adjusted by physicians to achieve the LDL-C target level &lt;100 milligrams per deciliter (mg/dL).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Alirocumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Alirocumab will be given subcutaneously every 2 weeks on top of stable dose statin therapy (atorvastatin or rosuvastatin) with or without stable dose non-statin LMTs.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Alirocumab SAR236553</intervention_name>
    <description>Pharmaceutical form: Solution for injection&#xD;
Route of administration: Subcutaneous</description>
    <arm_group_label>Alirocumab</arm_group_label>
    <other_name>Praluent</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Atorvastatin</intervention_name>
    <description>Pharmaceutical form: tablet&#xD;
Route of administration: oral</description>
    <arm_group_label>Alirocumab</arm_group_label>
    <arm_group_label>Standard of Care</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rosuvastatin</intervention_name>
    <description>Pharmaceutical form: tablet&#xD;
Route of administration: oral</description>
    <arm_group_label>Alirocumab</arm_group_label>
    <arm_group_label>Standard of Care</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fenofibrate</intervention_name>
    <description>Pharmaceutical form: tablet&#xD;
Route of administration: oral</description>
    <arm_group_label>Alirocumab</arm_group_label>
    <arm_group_label>Standard of Care</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bezafibrate</intervention_name>
    <description>Pharmaceutical form: tablet&#xD;
Route of administration: oral</description>
    <arm_group_label>Alirocumab</arm_group_label>
    <arm_group_label>Standard of Care</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ezetimibe</intervention_name>
    <description>Pharmaceutical form: tablet&#xD;
Route of administration: oral</description>
    <arm_group_label>Alirocumab</arm_group_label>
    <arm_group_label>Standard of Care</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Antiplatelets</intervention_name>
    <description>Pharmaceutical form: tablet or capsule&#xD;
Route of administration: oral</description>
    <arm_group_label>Alirocumab</arm_group_label>
    <arm_group_label>Standard of Care</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Anticoagulants</intervention_name>
    <description>Pharmaceutical form: tablet or capsule&#xD;
Route of administration: oral</description>
    <arm_group_label>Alirocumab</arm_group_label>
    <arm_group_label>Standard of Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria :&#xD;
&#xD;
          -  Participants hospitalized for ACS (Acute ST-segment elevation myocardial infarction&#xD;
             [STEMI], Acute non-ST-segment elevation myocardial infarction [NSTEMI], and unstable&#xD;
             angina.&#xD;
&#xD;
          -  LDL-C &gt;=100 mg/dL at ACS diagnosis.&#xD;
&#xD;
          -  Participants who has stenosis with at least &gt;50% stenosis angiographically within 1&#xD;
             week after the ACS onset, and has analyzable coronary intravascular Ultrasound image.&#xD;
&#xD;
          -  Participants aged &gt;=20 years old at ACS diagnosis.&#xD;
&#xD;
          -  Negative Hepatitis B surface antigen, negative Hepatitis B core antibody, and negative&#xD;
             Hepatitis C antibody. Or, negative Hepatitis B surface antigen, positive Hepatitis B&#xD;
             core antibody, negative Hepatitis B deoxyribonucleic acid, and negative Hepatitis C&#xD;
             antibody.&#xD;
&#xD;
          -  Written informed consent.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Participants who had previously treated with at least one dose of any anti-proprotein&#xD;
             convertase subtilisin/kexin type 9 monoclonal antibody.&#xD;
&#xD;
          -  Uncontrolled hypertension (multiple reading with systolic blood pressure &gt;180 mmHg or&#xD;
             diastolic blood pressure &gt;110 mmHg) between ACS diagnosis and randomization visit.&#xD;
&#xD;
          -  Known history of hemorrhagic stroke.&#xD;
&#xD;
          -  Currently under treatment for cancer.&#xD;
&#xD;
          -  Participants on LDL apheresis.&#xD;
&#xD;
          -  Any clinically significant abnormality identified that in the judgment of the&#xD;
             Investigator or any sub-Investigator would preclude safe completion of the study or&#xD;
             constrain endpoints assessment such as major systemic diseases, participants with&#xD;
             short life expectancy.&#xD;
&#xD;
          -  Considered by the Investigator or any sub-Investigator as inappropriate for this study&#xD;
             for any reason, including:&#xD;
&#xD;
               -  Unable to meet specific protocol requirements, such as scheduled visits;&#xD;
&#xD;
               -  Investigator or any sub-Investigator, pharmacist, study coordinator, other study&#xD;
                  staff or relative thereof directly involved in the conduct of the protocol, etc;&#xD;
&#xD;
               -  Presence of any other conditions (eg, geographic, social, etc.) actual or&#xD;
                  anticipated, that the Investigator feels would restrict or limit the&#xD;
                  participant's participation for the duration of the study.&#xD;
&#xD;
          -  Laboratory findings measured within 4 weeks after the ACS diagnosis (positive serum or&#xD;
             urine pregnancy test in females of childbearing potential).&#xD;
&#xD;
        The above information was not intended to contain all considerations relevant to a&#xD;
        participant's potential participation in a clinical trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clinical Sciences &amp; Operations</last_name>
    <role>Study Director</role>
    <affiliation>Sanofi</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Investigational Site Number 392026</name>
      <address>
        <city>Bunkyō-Ku</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392022</name>
      <address>
        <city>Chiyoda-ku</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392032</name>
      <address>
        <city>Fujisawa-shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392004</name>
      <address>
        <city>Fukui-shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392007</name>
      <address>
        <city>Fukuoka-shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392048</name>
      <address>
        <city>Fukuoka-shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392008</name>
      <address>
        <city>Gifu-shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392039</name>
      <address>
        <city>Hiroshima-shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392028</name>
      <address>
        <city>Isehara-shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392036</name>
      <address>
        <city>Itabashi-ku</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392037</name>
      <address>
        <city>Itabashi-ku</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392024</name>
      <address>
        <city>Izumisano-shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392013</name>
      <address>
        <city>Izunokuni-shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392020</name>
      <address>
        <city>Kawaguchi-shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392009</name>
      <address>
        <city>Kitakyushu-shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392034</name>
      <address>
        <city>Kitakyushu-shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392044</name>
      <address>
        <city>Kochi-shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392002</name>
      <address>
        <city>Kumamoto-shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392011</name>
      <address>
        <city>Kumamoto-shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392003</name>
      <address>
        <city>Kurashiki-shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392018</name>
      <address>
        <city>Matsuyama-shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392021</name>
      <address>
        <city>Morioka-shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392017</name>
      <address>
        <city>Nagakute-shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392047</name>
      <address>
        <city>Nagaoka-shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392033</name>
      <address>
        <city>Okayama-shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392006</name>
      <address>
        <city>Osaka-shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392010</name>
      <address>
        <city>Osaka-shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392045</name>
      <address>
        <city>Osaka-shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392046</name>
      <address>
        <city>Osaka-shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392015</name>
      <address>
        <city>Sagamihara-shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392019</name>
      <address>
        <city>Sakai-shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392035</name>
      <address>
        <city>Sapporo-shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392001</name>
      <address>
        <city>Tenri-shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392016</name>
      <address>
        <city>Toyoake-shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392025</name>
      <address>
        <city>Tsukuba-shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392040</name>
      <address>
        <city>Tsukuba-shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392005</name>
      <address>
        <city>Wakayama-shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392027</name>
      <address>
        <city>Yokohama-shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 392043</name>
      <address>
        <city>Yokohama-shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>December 5, 2016</study_first_submitted>
  <study_first_submitted_qc>December 5, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 7, 2016</study_first_posted>
  <results_first_submitted>July 26, 2019</results_first_submitted>
  <results_first_submitted_qc>July 26, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">September 9, 2019</results_first_posted>
  <last_update_submitted>July 26, 2019</last_update_submitted>
  <last_update_submitted_qc>July 26, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 9, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Coronary Syndrome</mesh_term>
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
    <mesh_term>Hypercholesterolemia</mesh_term>
    <mesh_term>Syndrome</mesh_term>
    <mesh_term>Plaque, Atherosclerotic</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anticoagulants</mesh_term>
    <mesh_term>Atorvastatin</mesh_term>
    <mesh_term>Rosuvastatin Calcium</mesh_term>
    <mesh_term>Ezetimibe</mesh_term>
    <mesh_term>Alirocumab</mesh_term>
    <mesh_term>Fenofibrate</mesh_term>
    <mesh_term>Bezafibrate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Not available for request.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 21, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/82/NCT02984982/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 11, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/82/NCT02984982/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The study was conducted at 39 active centers in Japan. Overall 214 participants were screened between 15 November 2016 and 02 November 2017, of whom 8 were screen failure and 206 were randomized to either alirocumab arm or standard of care (SoC) arm.</recruitment_details>
      <pre_assignment_details>Randomization was stratified by 'on statin therapy' or 'not on statin therapy' at the time of acute coronary syndrome (ACS) onset.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Standard of Care</title>
          <description>During the study period, participants randomized to the SoC arm, in a non-blinded manner, received orally, stable dose of statin therapy (atorvastatin greater than or equal to [&gt;=] 10 milligram per day [mg/day] or rosuvastatin &gt;=5 mg/day) with optional dose adjustment (within the range approved by health authority). In participants receiving statin monotherapy, non-statin, non-proprotein convertase subtilisin kexin type 9 (non-PCSK9) inhibitor lipid modifying therapies (LMTs) could be added by the investigators, if low-density lipoprotein cholesterol (LDL-C) target level less than (&lt;) 100 milligrams per deciliter (mg/dL) could not be achieved.</description>
        </group>
        <group group_id="P2">
          <title>Alirocumab</title>
          <description>Alirocumab (Praluent®) 75 mg subcutaneous (SC) injection every 2 weeks (Q2W) on top of stable dose statin therapy (atorvastatin &gt;=10 mg/day or rosuvastatin &gt;=5 mg/day). Statin (atorvastatin &gt;=10 mg/day or rosuvastatin &gt;=5 mg/day) and non-statin LMTs were continued at the same doses after ACS diagnosis unless modifications were necessary. Alirocumab (Praluent®) dose was increased to 150 mg Q2W at Week 14, if the Week 12 LDL-C was &gt;=100 mg/dL.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="102"/>
                <participants group_id="P2" count="104"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Treated</title>
              <participants_list>
                <participants group_id="P1" count="102"/>
                <participants group_id="P2" count="103"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="94"/>
                <participants group_id="P2" count="94"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Poor Compliance to Protocol</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Randomized but not treated</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Randomized population included all participants who were allocated to a randomized treatment and recorded in the registration center database, regardless of whether a study drug was used or not.</population>
      <group_list>
        <group group_id="B1">
          <title>Standard of Care</title>
          <description>During the study period, participants randomized to the SoC arm, in a non-blinded manner, received orally, stable dose of statin therapy (atorvastatin &gt;=10 mg/day or rosuvastatin &gt;=5 mg/day) with optional dose adjustment (within the range approved by health authority). In participants receiving statin monotherapy, non-statin, non-PCSK9 inhibitor LMTs could be added by the investigators, if LDL-C target level &lt;100 mg/dL could not be achieved.</description>
        </group>
        <group group_id="B2">
          <title>Alirocumab</title>
          <description>Alirocumab (Praluent®) 75 mg SC injection Q2W on top of stable dose statin therapy (atorvastatin &gt;=10 mg/day or rosuvastatin &gt;=5 mg/day). Statin (atorvastatin &gt;=10 mg/day or rosuvastatin &gt;=5 mg/day) and non-statin LMTs were continued at the same doses after ACS diagnosis unless modifications were necessary. Alirocumab (Praluent®) dose was increased to 150 mg Q2W at Week 14, if the Week 12 LDL-C was &gt;=100 mg/dL.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="102"/>
            <count group_id="B2" value="104"/>
            <count group_id="B3" value="206"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="102"/>
                    <count group_id="B2" value="104"/>
                    <count group_id="B3" value="206"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="60.0" spread="11.9"/>
                    <measurement group_id="B2" value="61.7" spread="10.9"/>
                    <measurement group_id="B3" value="60.9" spread="11.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="102"/>
                    <count group_id="B2" value="104"/>
                    <count group_id="B3" value="206"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="40"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="83"/>
                    <measurement group_id="B2" value="83"/>
                    <measurement group_id="B3" value="166"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="102"/>
                    <count group_id="B2" value="104"/>
                    <count group_id="B3" value="206"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="102"/>
                    <measurement group_id="B2" value="104"/>
                    <measurement group_id="B3" value="206"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Calculated LDL-C in mg/dL</title>
          <description>Calculated LDL-C in mg/dL from Friedewald formula (LDL cholesterol = Total cholesterol - high density lipoprotein [HDL] cholesterol - [Triglycerides/5]).</description>
          <population>&quot;Number analyzed&quot; = Number of participants evaluable for the specified baseline measure.</population>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="98"/>
                    <count group_id="B2" value="103"/>
                    <count group_id="B3" value="201"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="95.2" spread="22.6"/>
                    <measurement group_id="B2" value="98.5" spread="22.9"/>
                    <measurement group_id="B3" value="96.9" spread="22.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percent Change From Baseline in Normalized Total Atheroma Volume (TAV) at Week 36</title>
        <description>Least-squares (LS) means and standard errors (SE) at Week 36 were obtained from analysis of covariance (ANCOVA) model including treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]) as fixed categorical effects, and the baseline normalized TAV as continuous fixed covariate.</description>
        <time_frame>Baseline, Week 36</time_frame>
        <population>Modified intent-to-treat (mITT) population: all participants who were allocated to a randomized treatment, recorded in the registration center database, had at least one dose or part of dose of study drug and had 2 analyzable normalized TAV values, 1 assessed before randomization, and one assessed after 24 weeks of treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Standard of Care</title>
            <description>During the study period, participants randomized to the SoC arm, in a non-blinded manner, received orally, stable dose of statin therapy (atorvastatin &gt;=10 mg/day or rosuvastatin &gt;=5 mg/day) with optional dose adjustment (within the range approved by health authority). In participants receiving statin monotherapy, non-statin, non-PCSK9 inhibitor LMTs could be added by the investigators, if LDL-C target level &lt;100 mg/dL could not be achieved.</description>
          </group>
          <group group_id="O2">
            <title>Alirocumab</title>
            <description>Alirocumab (Praluent®) 75 mg SC injection Q2W on top of stable dose statin therapy (atorvastatin &gt;=10 mg/day or rosuvastatin &gt;=5 mg/day). Statin (atorvastatin &gt;=10 mg/day or rosuvastatin &gt;=5 mg/day) and non-statin LMTs were continued at the same doses after ACS diagnosis unless modifications were necessary. Alirocumab (Praluent®) dose was increased to 150 mg Q2W at Week 14, if the Week 12 LDL-C was &gt;=100 mg/dL.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Normalized Total Atheroma Volume (TAV) at Week 36</title>
          <description>Least-squares (LS) means and standard errors (SE) at Week 36 were obtained from analysis of covariance (ANCOVA) model including treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]) as fixed categorical effects, and the baseline normalized TAV as continuous fixed covariate.</description>
          <population>Modified intent-to-treat (mITT) population: all participants who were allocated to a randomized treatment, recorded in the registration center database, had at least one dose or part of dose of study drug and had 2 analyzable normalized TAV values, 1 assessed before randomization, and one assessed after 24 weeks of treatment.</population>
          <units>percent change</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="89"/>
                <count group_id="O2" value="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.14" spread="0.97"/>
                    <measurement group_id="O2" value="-4.79" spread="0.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Analysis was performed using ANCOVA model which included fixed categorical effects of treatment arm and randomization strata, as well as the continuous fixed covariate of baseline normalized TAV.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2279</p_value>
            <p_value_desc>Threshold for significance at 0.05 level.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>LS mean difference</param_type>
            <param_value>-1.64</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.36</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.32</ci_lower_limit>
            <ci_upper_limit>1.04</ci_upper_limit>
            <estimate_desc>Standard of Care vs Alirocumab</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Absolute Change From Baseline in Percent Atheroma Volume (PAV) at Week 36</title>
        <description>LS mean and SE at Week 36 were obtained from ANCOVA model including treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]) as fixed categorical effects, and the baseline PAV as continuous fixed covariate.</description>
        <time_frame>Baseline, Week 36</time_frame>
        <population>mITT population.</population>
        <group_list>
          <group group_id="O1">
            <title>Standard of Care</title>
            <description>During the study period, participants randomized to the SoC arm, in a non-blinded manner, received orally, stable dose of statin therapy (atorvastatin &gt;=10 mg/day or rosuvastatin &gt;=5 mg/day) with optional dose adjustment (within the range approved by health authority). In participants receiving statin monotherapy, non-statin, non-PCSK9 inhibitor LMTs could be added by the investigators, if LDL-C target level &lt;100 mg/dL could not be achieved.</description>
          </group>
          <group group_id="O2">
            <title>Alirocumab</title>
            <description>Alirocumab (Praluent®) 75 mg SC injection Q2W on top of stable dose statin therapy (atorvastatin &gt;=10 mg/day or rosuvastatin &gt;=5 mg/day). Statin (atorvastatin &gt;=10 mg/day or rosuvastatin &gt;=5 mg/day) and non-statin LMTs were continued at the same doses after ACS diagnosis unless modifications were necessary. Alirocumab (Praluent®) dose was increased to 150 mg Q2W at Week 14, if the Week 12 LDL-C was &gt;=100 mg/dL.</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Change From Baseline in Percent Atheroma Volume (PAV) at Week 36</title>
          <description>LS mean and SE at Week 36 were obtained from ANCOVA model including treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]) as fixed categorical effects, and the baseline PAV as continuous fixed covariate.</description>
          <population>mITT population.</population>
          <units>percent atheroma volume</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="89"/>
                <count group_id="O2" value="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.28" spread="0.39"/>
                    <measurement group_id="O2" value="-1.42" spread="0.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Absolute Change From Baseline in Normalized Total Atheroma Volume at Week 36</title>
        <description>LS mean and SE at Week 36 were obtained from ANCOVA model including treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]) as fixed categorical effects, and the baseline normalized TAV as continuous fixed covariate.</description>
        <time_frame>Baseline, Week 36</time_frame>
        <population>mITT population.</population>
        <group_list>
          <group group_id="O1">
            <title>Standard of Care</title>
            <description>During the study period, participants randomized to the SoC arm, in a non-blinded manner, received orally, stable dose of statin therapy (atorvastatin &gt;=10 mg/day or rosuvastatin &gt;=5 mg/day) with optional dose adjustment (within the range approved by health authority). In participants receiving statin monotherapy, non-statin, non-PCSK9 inhibitor LMTs could be added by the investigators, if LDL-C target level &lt;100 mg/dL could not be achieved.</description>
          </group>
          <group group_id="O2">
            <title>Alirocumab</title>
            <description>Alirocumab (Praluent®) 75 mg SC injection Q2W on top of stable dose statin therapy (atorvastatin &gt;=10 mg/day or rosuvastatin &gt;=5 mg/day). Statin (atorvastatin &gt;=10 mg/day or rosuvastatin &gt;=5 mg/day) and non-statin LMTs were continued at the same doses after ACS diagnosis unless modifications were necessary. Alirocumab (Praluent®) dose was increased to 150 mg Q2W at Week 14, if the Week 12 LDL-C was &gt;=100 mg/dL.</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Change From Baseline in Normalized Total Atheroma Volume at Week 36</title>
          <description>LS mean and SE at Week 36 were obtained from ANCOVA model including treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]) as fixed categorical effects, and the baseline normalized TAV as continuous fixed covariate.</description>
          <population>mITT population.</population>
          <units>cubic millimeter (mm^3)</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="89"/>
                <count group_id="O2" value="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.73" spread="1.02"/>
                    <measurement group_id="O2" value="-5.77" spread="1.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Absolute Change From Baseline in External Elastic Membrane (EEM) Volume at Week 36</title>
        <description>Adjusted mean and SE at Week 36 were obtained from robust regression model with treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]), as fixed categorical effects, and the baseline EEM volume value as continuous fixed covariate.</description>
        <time_frame>Baseline, Week 36</time_frame>
        <population>mITT population.</population>
        <group_list>
          <group group_id="O1">
            <title>Standard of Care</title>
            <description>During the study period, participants randomized to the SoC arm, in a non-blinded manner, received orally, stable dose of statin therapy (atorvastatin &gt;=10 mg/day or rosuvastatin &gt;=5 mg/day) with optional dose adjustment (within the range approved by health authority). In participants receiving statin monotherapy, non-statin, non-PCSK9 inhibitor LMTs could be added by the investigators, if LDL-C target level &lt;100 mg/dL could not be achieved.</description>
          </group>
          <group group_id="O2">
            <title>Alirocumab</title>
            <description>Alirocumab (Praluent®) 75 mg SC injection Q2W on top of stable dose statin therapy (atorvastatin &gt;=10 mg/day or rosuvastatin &gt;=5 mg/day). Statin (atorvastatin &gt;=10 mg/day or rosuvastatin &gt;=5 mg/day) and non-statin LMTs were continued at the same doses after ACS diagnosis unless modifications were necessary. Alirocumab (Praluent®) dose was increased to 150 mg Q2W at Week 14, if the Week 12 LDL-C was &gt;=100 mg/dL.</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Change From Baseline in External Elastic Membrane (EEM) Volume at Week 36</title>
          <description>Adjusted mean and SE at Week 36 were obtained from robust regression model with treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]), as fixed categorical effects, and the baseline EEM volume value as continuous fixed covariate.</description>
          <population>mITT population.</population>
          <units>mm^3</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="89"/>
                <count group_id="O2" value="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.23" spread="1.85"/>
                    <measurement group_id="O2" value="-10.01" spread="1.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in External Elastic Membrane Volume at Week 36</title>
        <description>Adjusted mean and SE at Week 36 were obtained from robust regression model including treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]) as fixed categorical effects, and the baseline EEM volume value as continuous fixed covariate.</description>
        <time_frame>Baseline, Week 36</time_frame>
        <population>mITT population.</population>
        <group_list>
          <group group_id="O1">
            <title>Standard of Care</title>
            <description>During the study period, participants randomized to the SoC arm, in a non-blinded manner, received orally, stable dose of statin therapy (atorvastatin &gt;=10 milligram per day [mg/day] or rosuvastatin &gt;=5 mg/day) with optional dose adjustment (within the range approved by health authority). In participants receiving statin monotherapy, non-statin, non-PCSK9 inhibitor lipid modifying therapies (LMTs) could be added by the investigators, if LDL-C target level &lt;100 mg/dL could not be achieved.</description>
          </group>
          <group group_id="O2">
            <title>Alirocumab</title>
            <description>Alirocumab (Praluent®) 75 mg SC injection Q2W on top of stable dose statin therapy (atorvastatin &gt;=10 mg/day or rosuvastatin &gt;=5 mg/day). Statin (atorvastatin &gt;=10 mg/day or rosuvastatin &gt;=5 mg/day) and non-statin LMTs were continued at the same doses after ACS diagnosis unless modifications were necessary. Alirocumab (Praluent®) dose was increased to 150 mg Q2W at Week 14, if the Week 12 LDL-C was &gt;=100 mg/dL.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in External Elastic Membrane Volume at Week 36</title>
          <description>Adjusted mean and SE at Week 36 were obtained from robust regression model including treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]) as fixed categorical effects, and the baseline EEM volume value as continuous fixed covariate.</description>
          <population>mITT population.</population>
          <units>percent change</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="89"/>
                <count group_id="O2" value="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.86" spread="0.93"/>
                    <measurement group_id="O2" value="-3.18" spread="0.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Absolute Change From Baseline in Lumen Volume at Week 36</title>
        <description>Adjusted mean and SE at Week 36 were obtained from robust regression model including treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]) as fixed categorical effects, and the baseline lumen volume value as continuous fixed covariate.</description>
        <time_frame>Baseline, Week 36</time_frame>
        <population>mITT population.</population>
        <group_list>
          <group group_id="O1">
            <title>Standard of Care</title>
            <description>During the study period, participants randomized to the SoC arm, in a non-blinded manner, received orally, stable dose of statin therapy (atorvastatin &gt;=10 mg/day or rosuvastatin &gt;=5 mg/day) with optional dose adjustment (within the range approved by health authority). In participants receiving statin monotherapy, non-statin, non-PCSK9 inhibitor LMTs could be added by the investigators, if LDL-C target level &lt;100 mg/dL could not be achieved.</description>
          </group>
          <group group_id="O2">
            <title>Alirocumab</title>
            <description>Alirocumab (Praluent®) 75 mg SC injection Q2W on top of stable dose statin therapy (atorvastatin &gt;=10 mg/day or rosuvastatin &gt;=5 mg/day). Statin (atorvastatin &gt;=10 mg/day or rosuvastatin &gt;=5 mg/day) and non-statin LMTs were continued at the same doses after ACS diagnosis unless modifications were necessary. Alirocumab (Praluent®) dose was increased to 150 mg Q2W at Week 14, if the Week 12 LDL-C was &gt;=100 mg/dL.</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Change From Baseline in Lumen Volume at Week 36</title>
          <description>Adjusted mean and SE at Week 36 were obtained from robust regression model including treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]) as fixed categorical effects, and the baseline lumen volume value as continuous fixed covariate.</description>
          <population>mITT population.</population>
          <units>mm^3</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="89"/>
                <count group_id="O2" value="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.25" spread="1.38"/>
                    <measurement group_id="O2" value="-0.93" spread="1.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in Lumen Volume at Week 36</title>
        <description>Adjusted mean and SE at Week 36 were obtained from robust regression model including treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]) as fixed categorical effect, and the baseline lumen volume value as continuous fixed covariate.</description>
        <time_frame>Baseline, Week 36</time_frame>
        <population>mITT population.</population>
        <group_list>
          <group group_id="O1">
            <title>Standard of Care</title>
            <description>During the study period, participants randomized to the SoC arm, in a non-blinded manner, received orally, stable dose of statin therapy (atorvastatin &gt;=10 mg/day or rosuvastatin &gt;=5 mg/day) with optional dose adjustment (within the range approved by health authority). In participants receiving statin monotherapy, non-statin, non-PCSK9 inhibitor LMTs could be added by the investigators, if LDL-C target level &lt;100 mg/dL could not be achieved.</description>
          </group>
          <group group_id="O2">
            <title>Alirocumab</title>
            <description>Alirocumab (Praluent®) 75 mg SC injection Q2W on top of stable dose statin therapy (atorvastatin &gt;=10 mg/day or rosuvastatin &gt;=5 mg/day). Statin (atorvastatin &gt;=10 mg/day or rosuvastatin &gt;=5 mg/day) and non-statin LMTs were continued at the same doses after ACS diagnosis unless modifications were necessary. Alirocumab (Praluent®) dose was increased to 150 mg Q2W at Week 14, if the Week 12 LDL-C was &gt;=100 mg/dL.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Lumen Volume at Week 36</title>
          <description>Adjusted mean and SE at Week 36 were obtained from robust regression model including treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]) as fixed categorical effect, and the baseline lumen volume value as continuous fixed covariate.</description>
          <population>mITT population.</population>
          <units>percent change</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="89"/>
                <count group_id="O2" value="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.20" spread="1.26"/>
                    <measurement group_id="O2" value="-0.86" spread="1.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Absolute Change From Baseline in Calculated Low-density Lipoprotein Cholesterol at Week 12 and Week 36</title>
        <description>Adjusted LS mean and SE at Week 12 and Week 36 were obtained from mixed-effect model including all available post-baseline data from Week 4 to Week 36. Model included treatment arm (SoC arm, alirocumab arm), randomization strata (statin at ACS onset [Yes / No]), time point, treatment-by-time point and randomization strata-by-time point interaction as fixed categorical effects, and baseline calculated LDL-C value and baseline calculated LDL-C value-by-time point interaction as continuous fixed covariates.</description>
        <time_frame>Baseline, Week 12, Week 36</time_frame>
        <population>Participants of the mITT population with one baseline and at least one post-baseline calculated LDL-C values.</population>
        <group_list>
          <group group_id="O1">
            <title>Standard of Care</title>
            <description>During the study period, participants randomized to the SoC arm, in a non-blinded manner, received orally, stable dose of statin therapy (atorvastatin &gt;=10 mg/day or rosuvastatin &gt;=5 mg/day) with optional dose adjustment (within the range approved by health authority). In participants receiving statin monotherapy, non-statin, non-PCSK9 inhibitor LMTs could be added by the investigators, if LDL-C target level &lt;100 mg/dL could not be achieved.</description>
          </group>
          <group group_id="O2">
            <title>Alirocumab</title>
            <description>Alirocumab (Praluent®) 75 mg SC injection Q2W on top of stable dose statin therapy (atorvastatin &gt;=10 mg/day or rosuvastatin &gt;=5 mg/day). Statin (atorvastatin &gt;=10 mg/day or rosuvastatin &gt;=5 mg/day) and non-statin LMTs were continued at the same doses after ACS diagnosis unless modifications were necessary. Alirocumab (Praluent®) dose was increased to 150 mg Q2W at Week 14, if the Week 12 LDL-C was &gt;=100 mg/dL.</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Change From Baseline in Calculated Low-density Lipoprotein Cholesterol at Week 12 and Week 36</title>
          <description>Adjusted LS mean and SE at Week 12 and Week 36 were obtained from mixed-effect model including all available post-baseline data from Week 4 to Week 36. Model included treatment arm (SoC arm, alirocumab arm), randomization strata (statin at ACS onset [Yes / No]), time point, treatment-by-time point and randomization strata-by-time point interaction as fixed categorical effects, and baseline calculated LDL-C value and baseline calculated LDL-C value-by-time point interaction as continuous fixed covariates.</description>
          <population>Participants of the mITT population with one baseline and at least one post-baseline calculated LDL-C values.</population>
          <units>mg/dL</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="85"/>
                <count group_id="O2" value="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-9.6" spread="1.7"/>
                    <measurement group_id="O2" value="-62.4" spread="1.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-15.5" spread="1.8"/>
                    <measurement group_id="O2" value="-63.2" spread="1.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in Calculated Low-density Lipoprotein Cholesterol at Week 12 and Week 36</title>
        <description>Adjusted LS mean and SE at Week 12 and Week 36 were obtained from mixed-effect model including all available post-baseline data from Week 4 to Week 36. Model included treatment arm (SoC arm, alirocumab arm), randomization strata (statin at ACS onset [Yes / No]), time point, treatment-by-time point and randomization strata-by-time point interaction as fixed categorical effects, and baseline calculated LDL-C value and baseline calculated LDL-C value-by-time point interaction as continuous fixed covariates.</description>
        <time_frame>Baseline, Week 12, Week 36</time_frame>
        <population>mITT population with one baseline and at least one post-baseline calculated LDL-C values.</population>
        <group_list>
          <group group_id="O1">
            <title>Standard of Care</title>
            <description>During the study period, participants randomized to the SoC arm, in a non-blinded manner, received orally, stable dose of statin therapy (atorvastatin &gt;=10 mg/day or rosuvastatin &gt;=5 mg/day) with optional dose adjustment (within the range approved by health authority). In participants receiving statin monotherapy, non-statin, non-PCSK9 inhibitor LMTs could be added by the investigators, if LDL-C target level &lt;100 mg/dL could not be achieved.</description>
          </group>
          <group group_id="O2">
            <title>Alirocumab</title>
            <description>Alirocumab (Praluent®) 75 mg SC injection Q2W on top of stable dose statin therapy (atorvastatin &gt;=10 mg/day or rosuvastatin &gt;=5 mg/day). Statin (atorvastatin &gt;=10 mg/day or rosuvastatin &gt;=5 mg/day) and non-statin LMTs were continued at the same doses after ACS diagnosis unless modifications were necessary. Alirocumab (Praluent®) dose was increased to 150 mg Q2W at Week 14, if the Week 12 LDL-C was &gt;=100 mg/dL.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Calculated Low-density Lipoprotein Cholesterol at Week 12 and Week 36</title>
          <description>Adjusted LS mean and SE at Week 12 and Week 36 were obtained from mixed-effect model including all available post-baseline data from Week 4 to Week 36. Model included treatment arm (SoC arm, alirocumab arm), randomization strata (statin at ACS onset [Yes / No]), time point, treatment-by-time point and randomization strata-by-time point interaction as fixed categorical effects, and baseline calculated LDL-C value and baseline calculated LDL-C value-by-time point interaction as continuous fixed covariates.</description>
          <population>mITT population with one baseline and at least one post-baseline calculated LDL-C values.</population>
          <units>percent change</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="85"/>
                <count group_id="O2" value="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.57" spread="1.91"/>
                    <measurement group_id="O2" value="-64.53" spread="1.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-13.40" spread="1.99"/>
                    <measurement group_id="O2" value="-63.94" spread="1.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Absolute Change From Baseline in Apolipoprotein B (Apo B) at Week 36</title>
        <description>Adjusted LS mean and SE at Week 36 were obtained from ANCOVA model including treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]) as fixed categorical effects, and baseline Apo B value as continuous fixed covariate.</description>
        <time_frame>Baseline, Week 36</time_frame>
        <population>Participants of the mITT population with one baseline and one post-baseline Apo B values.</population>
        <group_list>
          <group group_id="O1">
            <title>Standard of Care</title>
            <description>During the study period, participants randomized to the SoC arm, in a non-blinded manner, received orally, stable dose of statin therapy (atorvastatin &gt;=10 mg/day or rosuvastatin &gt;=5 mg/day) with optional dose adjustment (within the range approved by health authority). In participants receiving statin monotherapy, non-statin, non-PCSK9 inhibitor LMTs could be added by the investigators, if LDL-C target level &lt;100 mg/dL could not be achieved.</description>
          </group>
          <group group_id="O2">
            <title>Alirocumab</title>
            <description>Alirocumab (Praluent®) 75 mg SC injection Q2W on top of stable dose statin therapy (atorvastatin &gt;=10 mg/day or rosuvastatin &gt;=5 mg/day). Statin (atorvastatin &gt;=10 mg/day or rosuvastatin &gt;=5 mg/day) and non-statin LMTs were continued at the same doses after ACS diagnosis unless modifications were necessary. Alirocumab (Praluent®) dose was increased to 150 mg Q2W at Week 14, if the Week 12 LDL-C was &gt;=100 mg/dL.</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Change From Baseline in Apolipoprotein B (Apo B) at Week 36</title>
          <description>Adjusted LS mean and SE at Week 36 were obtained from ANCOVA model including treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]) as fixed categorical effects, and baseline Apo B value as continuous fixed covariate.</description>
          <population>Participants of the mITT population with one baseline and one post-baseline Apo B values.</population>
          <units>mg/dL</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="88"/>
                <count group_id="O2" value="92"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-16.8" spread="1.4"/>
                    <measurement group_id="O2" value="-51.0" spread="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in Apolipoprotein B at Week 36</title>
        <description>Adjusted LS mean and SE at Week 36 were obtained from ANCOVA model including treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]) as fixed categorical effects, and baseline Apo B value as continuous fixed covariate.</description>
        <time_frame>Baseline, Week 36</time_frame>
        <population>Participants of the mITT population with one baseline and one post-baseline Apo B values.</population>
        <group_list>
          <group group_id="O1">
            <title>Standard of Care</title>
            <description>During the study period, participants randomized to the SoC arm, in a non-blinded manner, received orally, stable dose of statin therapy (atorvastatin &gt;=10 mg/day or rosuvastatin &gt;=5 mg/day) with optional dose adjustment (within the range approved by health authority). In participants receiving statin monotherapy, non-statin, non-PCSK9 inhibitor LMTs could be added by the investigators, if LDL-C target level &lt;100 mg/dL could not be achieved.</description>
          </group>
          <group group_id="O2">
            <title>Alirocumab</title>
            <description>Alirocumab (Praluent®) 75 mg SC injection Q2W on top of stable dose statin therapy (atorvastatin &gt;=10 mg/day or rosuvastatin &gt;=5 mg/day). Statin (atorvastatin &gt;=10 mg/day or rosuvastatin &gt;=5 mg/day) and non-statin LMTs were continued at the same doses after ACS diagnosis unless modifications were necessary. Alirocumab (Praluent®) dose was increased to 150 mg Q2W at Week 14, if the Week 12 LDL-C was &gt;=100 mg/dL.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Apolipoprotein B at Week 36</title>
          <description>Adjusted LS mean and SE at Week 36 were obtained from ANCOVA model including treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]) as fixed categorical effects, and baseline Apo B value as continuous fixed covariate.</description>
          <population>Participants of the mITT population with one baseline and one post-baseline Apo B values.</population>
          <units>percent change</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="88"/>
                <count group_id="O2" value="92"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-16.61" spread="1.56"/>
                    <measurement group_id="O2" value="-55.13" spread="1.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Absolute Change From Baseline in Non-High-density Lipoprotein Cholesterol (Non-HDL-C) at Week 36</title>
        <description>Adjusted LS mean and SE at Week 36 were obtained from mixed-effect model including all available post-baseline data from Week 4 to Week 36. Model included treatment arm (SoC arm, alirocumab arm), randomization strata (statin at ACS onset [Yes / No]), time point, treatment-by-time point and randomization strata-by-time point interaction as fixed categorical effects, and baseline calculated non-HDL-C value and baseline calculated non-HDL-C value-by-time point interaction as continuous fixed covariates.</description>
        <time_frame>Baseline, Week 36</time_frame>
        <population>Participants of the mITT population with one baseline and at least one post-baseline Non-HDL-C values.</population>
        <group_list>
          <group group_id="O1">
            <title>Standard of Care</title>
            <description>During the study period, participants randomized to the SoC arm, in a non-blinded manner, received orally, stable dose of statin therapy (atorvastatin &gt;=10 mg/day or rosuvastatin &gt;=5 mg/day) with optional dose adjustment (within the range approved by health authority). In participants receiving statin monotherapy, non-statin, non-PCSK9 inhibitor LMTs could be added by the investigators, if LDL-C target level &lt;100 mg/dL could not be achieved.</description>
          </group>
          <group group_id="O2">
            <title>Alirocumab</title>
            <description>Alirocumab (Praluent®) 75 mg SC injection Q2W on top of stable dose statin therapy (atorvastatin &gt;=10 mg/day or rosuvastatin &gt;=5 mg/day). Statin (atorvastatin &gt;=10 mg/day or rosuvastatin &gt;=5 mg/day) and non-statin LMTs were continued at the same doses after ACS diagnosis unless modifications were necessary. Alirocumab (Praluent®) dose was increased to 150 mg Q2W at Week 14, if the Week 12 LDL-C was &gt;=100 mg/dL.</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Change From Baseline in Non-High-density Lipoprotein Cholesterol (Non-HDL-C) at Week 36</title>
          <description>Adjusted LS mean and SE at Week 36 were obtained from mixed-effect model including all available post-baseline data from Week 4 to Week 36. Model included treatment arm (SoC arm, alirocumab arm), randomization strata (statin at ACS onset [Yes / No]), time point, treatment-by-time point and randomization strata-by-time point interaction as fixed categorical effects, and baseline calculated non-HDL-C value and baseline calculated non-HDL-C value-by-time point interaction as continuous fixed covariates.</description>
          <population>Participants of the mITT population with one baseline and at least one post-baseline Non-HDL-C values.</population>
          <units>mg/dL</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="89"/>
                <count group_id="O2" value="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-20.3" spread="2.0"/>
                    <measurement group_id="O2" value="-69.2" spread="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in Non-High-density Lipoprotein Cholesterol at Week 36</title>
        <description>Adjusted LS mean and SE at Week 36 were obtained from mixed-effect model including all available post-baseline data from Week 4 to Week 36. Model included treatment arm (SoC arm, alirocumab arm), randomization strata (statin at ACS onset [Yes / No]), time point, treatment-by-time point and randomization strata-by-time point interaction as fixed categorical effects, and baseline calculated non-HDL-C value and baseline calculated non-HDL-C value-by-time point interaction as continuous fixed covariates.</description>
        <time_frame>Baseline, Week 36</time_frame>
        <population>Participants of the mITT population with one baseline and at least one post-baseline Non-HDL-C values.</population>
        <group_list>
          <group group_id="O1">
            <title>Standard of Care</title>
            <description>During the study period, participants randomized to the SoC arm, in a non-blinded manner, received orally, stable dose of statin therapy (atorvastatin &gt;=10 mg/day or rosuvastatin &gt;=5 mg/day) with optional dose adjustment (within the range approved by health authority). In participants receiving statin monotherapy, non-statin, non-PCSK9 inhibitor LMTs could be added by the investigators, if LDL-C target level &lt;100 mg/dL could not be achieved.</description>
          </group>
          <group group_id="O2">
            <title>Alirocumab</title>
            <description>Alirocumab (Praluent®) 75 mg SC injection Q2W on top of stable dose statin therapy (atorvastatin &gt;=10 mg/day or rosuvastatin &gt;=5 mg/day). Statin (atorvastatin &gt;=10 mg/day or rosuvastatin &gt;=5 mg/day) and non-statin LMTs were continued at the same doses after ACS diagnosis unless modifications were necessary. Alirocumab (Praluent®) dose was increased to 150 mg Q2W at Week 14, if the Week 12 LDL-C was &gt;=100 mg/dL.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Non-High-density Lipoprotein Cholesterol at Week 36</title>
          <description>Adjusted LS mean and SE at Week 36 were obtained from mixed-effect model including all available post-baseline data from Week 4 to Week 36. Model included treatment arm (SoC arm, alirocumab arm), randomization strata (statin at ACS onset [Yes / No]), time point, treatment-by-time point and randomization strata-by-time point interaction as fixed categorical effects, and baseline calculated non-HDL-C value and baseline calculated non-HDL-C value-by-time point interaction as continuous fixed covariates.</description>
          <population>Participants of the mITT population with one baseline and at least one post-baseline Non-HDL-C values.</population>
          <units>percent change</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="89"/>
                <count group_id="O2" value="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-14.06" spread="1.71"/>
                    <measurement group_id="O2" value="-54.50" spread="1.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Absolute Change From Baseline in Total Cholesterol (TC) at Week 36</title>
        <description>LS mean and SE at Week 36 were obtained from mixed-effect model including all available post-baseline data from Week 4 to Week 36. Model included treatment arm (SoC arm, alirocumab arm), randomization strata (statin at ACS onset [Yes / No]), time point, treatment-by-time point and randomization strata-by-time point interaction as fixed categorical effects, and baseline calculated TC value and baseline calculated TC value-by-time point interaction as continuous fixed covariates.</description>
        <time_frame>Baseline, Week 36</time_frame>
        <population>Participants of the mITT population with one baseline and at least one post-baseline TC values.</population>
        <group_list>
          <group group_id="O1">
            <title>Standard of Care</title>
            <description>During the study period, participants randomized to the SoC arm, in a non-blinded manner, received orally, stable dose of statin therapy (atorvastatin &gt;=10 mg/day or rosuvastatin &gt;=5 mg/day) with optional dose adjustment (within the range approved by health authority). In participants receiving statin monotherapy, non-statin, non-PCSK9 inhibitor LMTs could be added by the investigators, if LDL-C target level &lt;100 mg/dL could not be achieved.</description>
          </group>
          <group group_id="O2">
            <title>Alirocumab</title>
            <description>Alirocumab (Praluent®) 75 mg SC injection Q2W on top of stable dose statin therapy (atorvastatin &gt;=10 mg/day or rosuvastatin &gt;=5 mg/day). Statin (atorvastatin &gt;=10 mg/day or rosuvastatin &gt;=5 mg/day) and non-statin LMTs were continued at the same doses after ACS diagnosis unless modifications were necessary. Alirocumab (Praluent®) dose was increased to 150 mg Q2W at Week 14, if the Week 12 LDL-C was &gt;=100 mg/dL.</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Change From Baseline in Total Cholesterol (TC) at Week 36</title>
          <description>LS mean and SE at Week 36 were obtained from mixed-effect model including all available post-baseline data from Week 4 to Week 36. Model included treatment arm (SoC arm, alirocumab arm), randomization strata (statin at ACS onset [Yes / No]), time point, treatment-by-time point and randomization strata-by-time point interaction as fixed categorical effects, and baseline calculated TC value and baseline calculated TC value-by-time point interaction as continuous fixed covariates.</description>
          <population>Participants of the mITT population with one baseline and at least one post-baseline TC values.</population>
          <units>mg/dL</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="89"/>
                <count group_id="O2" value="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-15.2" spread="2.3"/>
                    <measurement group_id="O2" value="-61.7" spread="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in Total Cholesterol at Week 36</title>
        <description>Adjusted LS mean and SE at Week 36 were obtained from mixed-effect model including all available post-baseline data from Week 4 to Week 36. Model included treatment arm (SoC arm, alirocumab arm), randomization strata (statin at ACS onset [Yes / No]), time point, treatment-by-time point and randomization strata-by-time point interaction as fixed categorical effects, and baseline TC value and baseline TC value-by-time point interaction as continuous fixed covariates.</description>
        <time_frame>Baseline, Week 36</time_frame>
        <population>Participants of the mITT population with one baseline and at least one post-baseline TC values.</population>
        <group_list>
          <group group_id="O1">
            <title>Standard of Care</title>
            <description>During the study period, participants randomized to the SoC arm, in a non-blinded manner, received orally, stable dose of statin therapy (atorvastatin &gt;=10 mg/day or rosuvastatin &gt;=5 mg/day) with optional dose adjustment (within the range approved by health authority). In participants receiving statin monotherapy, non-statin, non-PCSK9 inhibitor LMTs could be added by the investigators, if LDL-C target level &lt;100 mg/dL could not be achieved.</description>
          </group>
          <group group_id="O2">
            <title>Alirocumab</title>
            <description>Alirocumab (Praluent®) 75 mg SC injection Q2W on top of stable dose statin therapy (atorvastatin &gt;=10 mg/day or rosuvastatin &gt;=5 mg/day). Statin (atorvastatin &gt;=10 mg/day or rosuvastatin &gt;=5 mg/day) and non-statin LMTs were continued at the same doses after ACS diagnosis unless modifications were necessary. Alirocumab (Praluent®) dose was increased to 150 mg Q2W at Week 14, if the Week 12 LDL-C was &gt;=100 mg/dL.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Total Cholesterol at Week 36</title>
          <description>Adjusted LS mean and SE at Week 36 were obtained from mixed-effect model including all available post-baseline data from Week 4 to Week 36. Model included treatment arm (SoC arm, alirocumab arm), randomization strata (statin at ACS onset [Yes / No]), time point, treatment-by-time point and randomization strata-by-time point interaction as fixed categorical effects, and baseline TC value and baseline TC value-by-time point interaction as continuous fixed covariates.</description>
          <population>Participants of the mITT population with one baseline and at least one post-baseline TC values.</population>
          <units>percent change</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="89"/>
                <count group_id="O2" value="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.59" spread="1.35"/>
                    <measurement group_id="O2" value="-35.43" spread="1.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Absolute Change From Baseline in Lipoprotein (a) (Lp[a]) at Week 36</title>
        <description>Adjusted mean and SE at Week 36 were obtained from robust regression model including treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]) as fixed categorical effect, and baseline Lp(a) value as continuous fixed covariate.</description>
        <time_frame>Baseline, Week 36</time_frame>
        <population>Participants of the mITT population with one baseline and post-baseline Lp(a) values.</population>
        <group_list>
          <group group_id="O1">
            <title>Standard of Care</title>
            <description>During the study period, participants randomized to the SoC arm, in a non-blinded manner, received orally, stable dose of statin therapy (atorvastatin &gt;=10 mg/day or rosuvastatin &gt;=5 mg/day) with optional dose adjustment (within the range approved by health authority). In participants receiving statin monotherapy, non-statin, non-PCSK9 inhibitor LMTs could be added by the investigators, if LDL-C target level &lt;100 mg/dL could not be achieved.</description>
          </group>
          <group group_id="O2">
            <title>Alirocumab</title>
            <description>Alirocumab (Praluent®) 75 mg SC injection Q2W on top of stable dose statin therapy (atorvastatin &gt;=10 mg/day or rosuvastatin &gt;=5 mg/day). Statin (atorvastatin &gt;=10 mg/day or rosuvastatin &gt;=5 mg/day) and non-statin LMTs were continued at the same doses after ACS diagnosis unless modifications were necessary. Alirocumab (Praluent®) dose was increased to 150 mg Q2W at Week 14, if the Week 12 LDL-C was &gt;=100 mg/dL.</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Change From Baseline in Lipoprotein (a) (Lp[a]) at Week 36</title>
          <description>Adjusted mean and SE at Week 36 were obtained from robust regression model including treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]) as fixed categorical effect, and baseline Lp(a) value as continuous fixed covariate.</description>
          <population>Participants of the mITT population with one baseline and post-baseline Lp(a) values.</population>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="88"/>
                <count group_id="O2" value="92"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-10.3" spread="0.5"/>
                    <measurement group_id="O2" value="-15.5" spread="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in Lipoprotein (a) at Week 36</title>
        <description>Adjusted mean and SE at Week 36 were obtained from robust regression model including treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]) as fixed categorical effect, and baseline Lp(a) value as continuous fixed covariate.</description>
        <time_frame>Baseline, Week 36</time_frame>
        <population>Participants of the mITT population with one baseline and one post-baseline Lp(a) values.</population>
        <group_list>
          <group group_id="O1">
            <title>Standard of Care</title>
            <description>During the study period, participants randomized to the SoC arm, in a non-blinded manner, received orally, stable dose of statin therapy (atorvastatin &gt;=10 mg/day or rosuvastatin &gt;=5 mg/day) with optional dose adjustment (within the range approved by health authority). In participants receiving statin monotherapy, non-statin, non-PCSK9 inhibitor LMTs could be added by the investigators, if LDL-C target level &lt;100 mg/dL could not be achieved.</description>
          </group>
          <group group_id="O2">
            <title>Alirocumab</title>
            <description>Alirocumab (Praluent®) 75 mg SC injection Q2W on top of stable dose statin therapy (atorvastatin &gt;=10 mg/day or rosuvastatin &gt;=5 mg/day). Statin (atorvastatin &gt;=10 mg/day or rosuvastatin &gt;=5 mg/day) and non-statin LMTs were continued at the same doses after ACS diagnosis unless modifications were necessary. Alirocumab (Praluent®) dose was increased to 150 mg Q2W at Week 14, if the Week 12 LDL-C was &gt;=100 mg/dL.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Lipoprotein (a) at Week 36</title>
          <description>Adjusted mean and SE at Week 36 were obtained from robust regression model including treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]) as fixed categorical effect, and baseline Lp(a) value as continuous fixed covariate.</description>
          <population>Participants of the mITT population with one baseline and one post-baseline Lp(a) values.</population>
          <units>percent change</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="88"/>
                <count group_id="O2" value="92"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-17.23" spread="2.60"/>
                    <measurement group_id="O2" value="-55.76" spread="2.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Absolute Change From Baseline in High-density Lipoprotein Cholesterol at Week 36</title>
        <description>Adjusted LS mean and SE at Week 36 were obtained from mixed-effect model including all available post-baseline data from Week 4 to Week 36. Model included treatment arm (SoC arm, alirocumab arm), randomization strata (statin at ACS onset [Yes / No]), time point, treatment-by-time point and randomization strata-by-time point interaction as fixed categorical effects, and baseline HDL-C value and baseline HDL-C value-by-time point interaction as continuous fixed covariates.</description>
        <time_frame>Baseline, Week 36</time_frame>
        <population>Participants of the mITT population with one baseline and at least one post-baseline HDL-C values.</population>
        <group_list>
          <group group_id="O1">
            <title>Standard of Care</title>
            <description>During the study period, participants randomized to the SoC arm, in a non-blinded manner, received orally, stable dose of statin therapy (atorvastatin &gt;=10 mg/day or rosuvastatin &gt;=5 mg/day) with optional dose adjustment (within the range approved by health authority). In participants receiving statin monotherapy, non-statin, non-PCSK9 inhibitor LMTs could be added by the investigators, if LDL-C target level &lt;100 mg/dL could not be achieved.</description>
          </group>
          <group group_id="O2">
            <title>Alirocumab</title>
            <description>Alirocumab (Praluent®) 75 mg SC injection Q2W on top of stable dose statin therapy (atorvastatin &gt;=10 mg/day or rosuvastatin &gt;=5 mg/day). Statin (atorvastatin &gt;=10 mg/day or rosuvastatin &gt;=5 mg/day) and non-statin LMTs were continued at the same doses after ACS diagnosis unless modifications were necessary. Alirocumab (Praluent®) dose was increased to 150 mg Q2W at Week 14, if the Week 12 LDL-C was &gt;=100 mg/dL.</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Change From Baseline in High-density Lipoprotein Cholesterol at Week 36</title>
          <description>Adjusted LS mean and SE at Week 36 were obtained from mixed-effect model including all available post-baseline data from Week 4 to Week 36. Model included treatment arm (SoC arm, alirocumab arm), randomization strata (statin at ACS onset [Yes / No]), time point, treatment-by-time point and randomization strata-by-time point interaction as fixed categorical effects, and baseline HDL-C value and baseline HDL-C value-by-time point interaction as continuous fixed covariates.</description>
          <population>Participants of the mITT population with one baseline and at least one post-baseline HDL-C values.</population>
          <units>mg/dL</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="89"/>
                <count group_id="O2" value="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.7" spread="0.9"/>
                    <measurement group_id="O2" value="8.1" spread="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in High-density Lipoprotein Cholesterol at Week 36</title>
        <description>Adjusted LS mean and SE at Week 36 were obtained from mixed-effect model including all available post-baseline data from Week 4 to Week 36. Model included treatment arm (SoC arm, alirocumab arm), randomization strata (statin at ACS onset [Yes / No]), time point, treatment-by-time point and randomization strata-by-time point interaction as fixed categorical effects, and baseline HDL-C value and baseline HDL-C value-by-time point interaction as continuous fixed covariates.</description>
        <time_frame>Baseline, Week 36</time_frame>
        <population>Participants of the mITT population with one baseline and at least one post-baseline HDL-C values.</population>
        <group_list>
          <group group_id="O1">
            <title>Standard of Care</title>
            <description>During the study period, participants randomized to the SoC arm, in a non-blinded manner, received orally, stable dose of statin therapy (atorvastatin &gt;=10 mg/day or rosuvastatin &gt;=5 mg/day) with optional dose adjustment (within the range approved by health authority). In participants receiving statin monotherapy, non-statin, non-PCSK9 inhibitor LMTs could be added by the investigators, if LDL-C target level &lt;100 mg/dL could not be achieved.</description>
          </group>
          <group group_id="O2">
            <title>Alirocumab</title>
            <description>Alirocumab (Praluent®) 75 mg SC injection Q2W on top of stable dose statin therapy (atorvastatin &gt;=10 mg/day or rosuvastatin &gt;=5 mg/day). Statin (atorvastatin &gt;=10 mg/day or rosuvastatin &gt;=5 mg/day) and non-statin LMTs were continued at the same doses after ACS diagnosis unless modifications were necessary. Alirocumab (Praluent®) dose was increased to 150 mg Q2W at Week 14, if the Week 12 LDL-C was &gt;=100 mg/dL.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in High-density Lipoprotein Cholesterol at Week 36</title>
          <description>Adjusted LS mean and SE at Week 36 were obtained from mixed-effect model including all available post-baseline data from Week 4 to Week 36. Model included treatment arm (SoC arm, alirocumab arm), randomization strata (statin at ACS onset [Yes / No]), time point, treatment-by-time point and randomization strata-by-time point interaction as fixed categorical effects, and baseline HDL-C value and baseline HDL-C value-by-time point interaction as continuous fixed covariates.</description>
          <population>Participants of the mITT population with one baseline and at least one post-baseline HDL-C values.</population>
          <units>percent change</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="89"/>
                <count group_id="O2" value="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.19" spread="2.30"/>
                    <measurement group_id="O2" value="21.04" spread="2.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Absolute Change From Baseline in Fasting Triglycerides (TGs) at Week 36</title>
        <description>Adjusted mean and SE were obtained from multiple imputation approach followed by robust regression model including fixed categorical effect of treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]) and the continuous fixed covariate of baseline fasting TGs value.</description>
        <time_frame>Baseline, Week 36</time_frame>
        <population>Participants of the mITT population with one baseline and at least one post-baseline fasting TGs values.</population>
        <group_list>
          <group group_id="O1">
            <title>Standard of Care</title>
            <description>During the study period, participants randomized to the SoC arm, in a non-blinded manner, received orally, stable dose of statin therapy (atorvastatin &gt;=10 mg/day or rosuvastatin &gt;=5 mg/day) with optional dose adjustment (within the range approved by health authority). In participants receiving statin monotherapy, non-statin, non-PCSK9 inhibitor LMTs could be added by the investigators, if LDL-C target level &lt;100 mg/dL could not be achieved.</description>
          </group>
          <group group_id="O2">
            <title>Alirocumab</title>
            <description>Alirocumab (Praluent®) 75 mg SC injection Q2W on top of stable dose statin therapy (atorvastatin &gt;=10 mg/day or rosuvastatin &gt;=5 mg/day). Statin (atorvastatin &gt;=10 mg/day or rosuvastatin &gt;=5 mg/day) and non-statin LMTs were continued at the same doses after ACS diagnosis unless modifications were necessary. Alirocumab (Praluent®) dose was increased to 150 mg Q2W at Week 14, if the Week 12 LDL-C was &gt;=100 mg/dL.</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Change From Baseline in Fasting Triglycerides (TGs) at Week 36</title>
          <description>Adjusted mean and SE were obtained from multiple imputation approach followed by robust regression model including fixed categorical effect of treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]) and the continuous fixed covariate of baseline fasting TGs value.</description>
          <population>Participants of the mITT population with one baseline and at least one post-baseline fasting TGs values.</population>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="89"/>
                <count group_id="O2" value="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-26.2" spread="4.7"/>
                    <measurement group_id="O2" value="-35.3" spread="4.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in Fasting Triglycerides at Week 36</title>
        <description>Adjusted mean and SE were obtained by multiple imputation approach followed by robust regression model included fixed categorical effect of treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]) and the continuous fixed covariate of baseline fasting TGs value.</description>
        <time_frame>Baseline, Week 36</time_frame>
        <population>Participants of the mITT population with one baseline and at least one post-baseline fasting TGs values.</population>
        <group_list>
          <group group_id="O1">
            <title>Standard of Care</title>
            <description>During the study period, participants randomized to the SoC arm, in a non-blinded manner, received orally, stable dose of statin therapy (atorvastatin &gt;=10 mg/day or rosuvastatin &gt;=5 mg/day) with optional dose adjustment (within the range approved by health authority). In participants receiving statin monotherapy, non-statin, non-PCSK9 inhibitor LMTs could be added by the investigators, if LDL-C target level &lt;100 mg/dL could not be achieved.</description>
          </group>
          <group group_id="O2">
            <title>Alirocumab</title>
            <description>Alirocumab (Praluent®) 75 mg SC injection Q2W on top of stable dose statin therapy (atorvastatin &gt;=10 mg/day or rosuvastatin &gt;=5 mg/day). Statin (atorvastatin &gt;=10 mg/day or rosuvastatin &gt;=5 mg/day) and non-statin LMTs were continued at the same doses after ACS diagnosis unless modifications were necessary. Alirocumab (Praluent®) dose was increased to 150 mg Q2W at Week 14, if the Week 12 LDL-C was &gt;=100 mg/dL.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Fasting Triglycerides at Week 36</title>
          <description>Adjusted mean and SE were obtained by multiple imputation approach followed by robust regression model included fixed categorical effect of treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]) and the continuous fixed covariate of baseline fasting TGs value.</description>
          <population>Participants of the mITT population with one baseline and at least one post-baseline fasting TGs values.</population>
          <units>percent change</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="89"/>
                <count group_id="O2" value="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.85" spread="3.62"/>
                    <measurement group_id="O2" value="-18.37" spread="3.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Absolute Change From Baseline in Apolipoprotein A-1 (Apo A-1) at Week 36</title>
        <description>Adjusted LS mean and SE at Week 36 were obtained from ANCOVA model including treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]) as fixed categorical effects, and baseline Apo A-1 value as continuous fixed covariate.</description>
        <time_frame>Baseline, Week 36</time_frame>
        <population>Participants of the mITT population with one baseline and one post-baseline Apo A-1 values.</population>
        <group_list>
          <group group_id="O1">
            <title>Standard of Care</title>
            <description>During the study period, participants randomized to the SoC arm, in a non-blinded manner, received orally, stable dose of statin therapy (atorvastatin &gt;=10 mg/day or rosuvastatin &gt;=5 mg/day) with optional dose adjustment (within the range approved by health authority). In participants receiving statin monotherapy, non-statin, non-PCSK9 inhibitor LMTs could be added by the investigators, if LDL-C target level &lt;100 mg/dL could not be achieved.</description>
          </group>
          <group group_id="O2">
            <title>Alirocumab</title>
            <description>Alirocumab (Praluent®) 75 mg SC injection Q2W on top of stable dose statin therapy (atorvastatin &gt;=10 mg/day or rosuvastatin &gt;=5 mg/day). Statin (atorvastatin &gt;=10 mg/day or rosuvastatin &gt;=5 mg/day) and non-statin LMTs were continued at the same doses after ACS diagnosis unless modifications were necessary. Alirocumab (Praluent®) dose was increased to 150 mg Q2W at Week 14, if the Week 12 LDL-C was &gt;=100 mg/dL.</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Change From Baseline in Apolipoprotein A-1 (Apo A-1) at Week 36</title>
          <description>Adjusted LS mean and SE at Week 36 were obtained from ANCOVA model including treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]) as fixed categorical effects, and baseline Apo A-1 value as continuous fixed covariate.</description>
          <population>Participants of the mITT population with one baseline and one post-baseline Apo A-1 values.</population>
          <units>mg/dL</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="88"/>
                <count group_id="O2" value="92"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.8" spread="1.9"/>
                    <measurement group_id="O2" value="12.0" spread="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in Apolipoprotein A-1 at Week 36</title>
        <description>Adjusted LS mean and SE at Week 36 were obtained from ANCOVA model including treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]) as fixed categorical effects, and baseline Apo A-1 value as continuous fixed covariate.</description>
        <time_frame>Baseline, Week 36</time_frame>
        <population>Participants of the mITT population with one baseline and one post-baseline Apo A-1 values.</population>
        <group_list>
          <group group_id="O1">
            <title>Standard of Care</title>
            <description>During the study period, participants randomized to the SoC arm, in a non-blinded manner, received orally, stable dose of statin therapy (atorvastatin &gt;=10 mg/day or rosuvastatin &gt;=5 mg/day) with optional dose adjustment (within the range approved by health authority). In participants receiving statin monotherapy, non-statin, non-PCSK9 inhibitor LMTs could be added by the investigators, if LDL-C target level &lt;100 mg/dL could not be achieved.</description>
          </group>
          <group group_id="O2">
            <title>Alirocumab</title>
            <description>Alirocumab (Praluent®) 75 mg SC injection Q2W on top of stable dose statin therapy (atorvastatin &gt;=10 mg/day or rosuvastatin &gt;=5 mg/day). Statin (atorvastatin &gt;=10 mg/day or rosuvastatin &gt;=5 mg/day) and non-statin LMTs were continued at the same doses after ACS diagnosis unless modifications were necessary. Alirocumab (Praluent®) dose was increased to 150 mg Q2W at Week 14, if the Week 12 LDL-C was &gt;=100 mg/dL.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in Apolipoprotein A-1 at Week 36</title>
          <description>Adjusted LS mean and SE at Week 36 were obtained from ANCOVA model including treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]) as fixed categorical effects, and baseline Apo A-1 value as continuous fixed covariate.</description>
          <population>Participants of the mITT population with one baseline and one post-baseline Apo A-1 values.</population>
          <units>percent change</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="88"/>
                <count group_id="O2" value="92"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.61" spread="1.62"/>
                    <measurement group_id="O2" value="11.75" spread="1.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Cardiovascular (CV) Adverse Events</title>
        <description>The suspected or confirmed CV events that occurred from randomization until end of the study visit were collected and reported. The various CV events included CV death, myocardial infarction, ischemic stroke, unstable angina requiring hospitalization , congestive heart failure requiring hospitalization, congestive heart failure requiring hospitalization, ischemia-driven coronary revascularization procedure.</description>
        <time_frame>Up to 36 weeks</time_frame>
        <population>Safety population: all participants who actually received at least 1 dose or part of a dose of the study drug, and analyzed according to the treatment actually received.</population>
        <group_list>
          <group group_id="O1">
            <title>Standard of Care</title>
            <description>During the study period, participants randomized to the SoC arm, in a non-blinded manner, received orally, stable dose of statin therapy (atorvastatin &gt;=10 mg/day or rosuvastatin &gt;=5 mg/day) with optional dose adjustment (within the range approved by health authority). In participants receiving statin monotherapy, non-statin, non-PCSK9 inhibitor LMTs could be added by the investigators, if LDL-C target level &lt;100 mg/dL could not be achieved.</description>
          </group>
          <group group_id="O2">
            <title>Alirocumab</title>
            <description>Alirocumab (Praluent®) 75 mg SC injection Q2W on top of stable dose statin therapy (atorvastatin &gt;=10 mg/day or rosuvastatin &gt;=5 mg/day). Statin (atorvastatin &gt;=10 mg/day or rosuvastatin &gt;=5 mg/day) and non-statin LMTs were continued at the same doses after ACS diagnosis unless modifications were necessary. Alirocumab (Praluent®) dose was increased to 150 mg Q2W at Week 14, if the Week 12 LDL-C was &gt;=100 mg/dL.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Cardiovascular (CV) Adverse Events</title>
          <description>The suspected or confirmed CV events that occurred from randomization until end of the study visit were collected and reported. The various CV events included CV death, myocardial infarction, ischemic stroke, unstable angina requiring hospitalization , congestive heart failure requiring hospitalization, congestive heart failure requiring hospitalization, ischemia-driven coronary revascularization procedure.</description>
          <population>Safety population: all participants who actually received at least 1 dose or part of a dose of the study drug, and analyzed according to the treatment actually received.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="102"/>
                <count group_id="O2" value="103"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cardiovascular death</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Myocardial infarction</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ischemic stroke</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unstable angina requiring hospitalization</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Congestive heart failure requiring hospitalization</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ischemia led coronary revascularization procedure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>All Adverse Events (AEs) were collected from signature of the informed consent form up to 21 days after last dose of study drug, or end of study, whichever comes first (up to 39 weeks) regardless of seriousness or relationship to investigational product</time_frame>
      <desc>Reported AEs and deaths are treatment-emergent adverse events that developed/worsened during the treatment-emergent period (time from first dose of investigational medicinal product (IMP) up to last dose of IMP +21 days, or end of study, whichever comes first). Analysis was performed on safety population.</desc>
      <group_list>
        <group group_id="E1">
          <title>Standard of Care</title>
          <description>During the study period, participants randomized to the SoC arm, in a non-blinded manner, received orally, stable dose of statin therapy (atorvastatin &gt;=10 mg/day or rosuvastatin &gt;=5 mg/day) with optional dose adjustment (within the range approved by health authority). In participants receiving statin monotherapy, non-statin, non-PCSK9 inhibitor LMTs could be added by the investigators, if LDL-C target level &lt;100 mg/dL could not be achieved.</description>
        </group>
        <group group_id="E2">
          <title>Alirocumab</title>
          <description>Alirocumab (Praluent®) 75 mg SC injection Q2W on top of stable dose statin therapy (atorvastatin &gt;=10 mg/day or rosuvastatin &gt;=5 mg/day). Statin (atorvastatin &gt;=10 mg/day or rosuvastatin &gt;=5 mg/day) and non-statin LMTs were continued at the same doses after ACS diagnosis unless modifications were necessary. Alirocumab (Praluent®) dose was increased to 150 mg Q2W at Week 14, if the Week 12 LDL-C was &gt;=100 mg/dL.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 21.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute coronary syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Angina unstable</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Coronary artery dissection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Coronary artery stenosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Myocardial ischaemia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Prinzmetal angina</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Ventricular tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Haemorrhoids</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Incarcerated inguinal hernia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Vascular stent stenosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Drug-induced liver injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Hepatic function abnormal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Liver disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Anal abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Coronary artery reocclusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Vascular pseudoaneurysm</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Lung adenocarcinoma stage I</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Rectal cancer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebral infarction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Transient ischaemic attack</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Nephropathy toxic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Peripheral arterial occlusive disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 21.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="33" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Injection site reaction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="27" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="102"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Trial Transparency Team</name_or_title>
      <organization>Sanofi</organization>
      <phone>800-633-1610 ext 1#</phone>
      <email>Contact-US@sanofi.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02984982
org study id: ALIROL08069
secondary id: U1111-1184-8764
nct id: NCT02984982
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated device: No
is us export: No
Primary Objective:

      To compare the efficacy of alirocumab (Praluent®) with standard of care (SoC) on coronary
      atheroma progression (percent change in normalized total atheroma volume [TAV]) after 9
      months of treatment in participants who had acute coronary syndrome (ACS) within 4 weeks
      prior to randomization, with hypercholesterolemia treated with statin.

      Secondary Objectives:

        -  To compare the efficacy of alirocumab (Praluent®) with SoC on secondary endpoints
           including absolute change in percent atheroma volume and normalized TAV after 9 months
           of treatment.

        -  To evaluate the efficacy of alirocumab (Praluent®) on low-density lipoprotein
           cholesterol (LDL-C), apolipoprotein B, triglycerides, non-high-density lipoprotein
           cholesterol and lipoprotein (a) after 9 months treatment.

        -  To evaluate the safety of alirocumab (Praluent®) including the occurrence of
           cardiovascular events (coronary heart disease death, non-fatal myocardial infarction,
           fatal and non-fatal ischemic stroke, unstable angina requiring hospitalization)
           throughout the study.
The duration of study per participant was 9 months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percent Change From Baseline in Normalized Total Atheroma Volume (TAV) at Week 36
time frame: Baseline, Week 36
description: Least-squares (LS) means and standard errors (SE) at Week 36 were obtained from analysis of covariance (ANCOVA) model including treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]) as fixed categorical effects, and the baseline normalized TAV as continuous fixed covariate.
measure: Absolute Change From Baseline in Percent Atheroma Volume (PAV) at Week 36
time frame: Baseline, Week 36
description: LS mean and SE at Week 36 were obtained from ANCOVA model including treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]) as fixed categorical effects, and the baseline PAV as continuous fixed covariate.
measure: Absolute Change From Baseline in Normalized Total Atheroma Volume at Week 36
time frame: Baseline, Week 36
description: LS mean and SE at Week 36 were obtained from ANCOVA model including treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]) as fixed categorical effects, and the baseline normalized TAV as continuous fixed covariate.
measure: Absolute Change From Baseline in External Elastic Membrane (EEM) Volume at Week 36
time frame: Baseline, Week 36
description: Adjusted mean and SE at Week 36 were obtained from robust regression model with treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]), as fixed categorical effects, and the baseline EEM volume value as continuous fixed covariate.
measure: Percent Change From Baseline in External Elastic Membrane Volume at Week 36
time frame: Baseline, Week 36
description: Adjusted mean and SE at Week 36 were obtained from robust regression model including treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]) as fixed categorical effects, and the baseline EEM volume value as continuous fixed covariate.
measure: Absolute Change From Baseline in Lumen Volume at Week 36
time frame: Baseline, Week 36
description: Adjusted mean and SE at Week 36 were obtained from robust regression model including treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]) as fixed categorical effects, and the baseline lumen volume value as continuous fixed covariate.
measure: Percent Change From Baseline in Lumen Volume at Week 36
time frame: Baseline, Week 36
description: Adjusted mean and SE at Week 36 were obtained from robust regression model including treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]) as fixed categorical effect, and the baseline lumen volume value as continuous fixed covariate.
measure: Absolute Change From Baseline in Calculated Low-density Lipoprotein Cholesterol at Week 12 and Week 36
time frame: Baseline, Week 12, Week 36
description: Adjusted LS mean and SE at Week 12 and Week 36 were obtained from mixed-effect model including all available post-baseline data from Week 4 to Week 36. Model included treatment arm (SoC arm, alirocumab arm), randomization strata (statin at ACS onset [Yes / No]), time point, treatment-by-time point and randomization strata-by-time point interaction as fixed categorical effects, and baseline calculated LDL-C value and baseline calculated LDL-C value-by-time point interaction as continuous fixed covariates.
measure: Percent Change From Baseline in Calculated Low-density Lipoprotein Cholesterol at Week 12 and Week 36
time frame: Baseline, Week 12, Week 36
description: Adjusted LS mean and SE at Week 12 and Week 36 were obtained from mixed-effect model including all available post-baseline data from Week 4 to Week 36. Model included treatment arm (SoC arm, alirocumab arm), randomization strata (statin at ACS onset [Yes / No]), time point, treatment-by-time point and randomization strata-by-time point interaction as fixed categorical effects, and baseline calculated LDL-C value and baseline calculated LDL-C value-by-time point interaction as continuous fixed covariates.
measure: Absolute Change From Baseline in Apolipoprotein B (Apo B) at Week 36
time frame: Baseline, Week 36
description: Adjusted LS mean and SE at Week 36 were obtained from ANCOVA model including treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]) as fixed categorical effects, and baseline Apo B value as continuous fixed covariate.
measure: Percent Change From Baseline in Apolipoprotein B at Week 36
time frame: Baseline, Week 36
description: Adjusted LS mean and SE at Week 36 were obtained from ANCOVA model including treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]) as fixed categorical effects, and baseline Apo B value as continuous fixed covariate.
measure: Absolute Change From Baseline in Non-High-density Lipoprotein Cholesterol (Non-HDL-C) at Week 36
time frame: Baseline, Week 36
description: Adjusted LS mean and SE at Week 36 were obtained from mixed-effect model including all available post-baseline data from Week 4 to Week 36. Model included treatment arm (SoC arm, alirocumab arm), randomization strata (statin at ACS onset [Yes / No]), time point, treatment-by-time point and randomization strata-by-time point interaction as fixed categorical effects, and baseline calculated non-HDL-C value and baseline calculated non-HDL-C value-by-time point interaction as continuous fixed covariates.
measure: Percent Change From Baseline in Non-High-density Lipoprotein Cholesterol at Week 36
time frame: Baseline, Week 36
description: Adjusted LS mean and SE at Week 36 were obtained from mixed-effect model including all available post-baseline data from Week 4 to Week 36. Model included treatment arm (SoC arm, alirocumab arm), randomization strata (statin at ACS onset [Yes / No]), time point, treatment-by-time point and randomization strata-by-time point interaction as fixed categorical effects, and baseline calculated non-HDL-C value and baseline calculated non-HDL-C value-by-time point interaction as continuous fixed covariates.
measure: Absolute Change From Baseline in Total Cholesterol (TC) at Week 36
time frame: Baseline, Week 36
description: LS mean and SE at Week 36 were obtained from mixed-effect model including all available post-baseline data from Week 4 to Week 36. Model included treatment arm (SoC arm, alirocumab arm), randomization strata (statin at ACS onset [Yes / No]), time point, treatment-by-time point and randomization strata-by-time point interaction as fixed categorical effects, and baseline calculated TC value and baseline calculated TC value-by-time point interaction as continuous fixed covariates.
measure: Percent Change From Baseline in Total Cholesterol at Week 36
time frame: Baseline, Week 36
description: Adjusted LS mean and SE at Week 36 were obtained from mixed-effect model including all available post-baseline data from Week 4 to Week 36. Model included treatment arm (SoC arm, alirocumab arm), randomization strata (statin at ACS onset [Yes / No]), time point, treatment-by-time point and randomization strata-by-time point interaction as fixed categorical effects, and baseline TC value and baseline TC value-by-time point interaction as continuous fixed covariates.
measure: Absolute Change From Baseline in Lipoprotein (a) (Lp[a]) at Week 36
time frame: Baseline, Week 36
description: Adjusted mean and SE at Week 36 were obtained from robust regression model including treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]) as fixed categorical effect, and baseline Lp(a) value as continuous fixed covariate.
measure: Percent Change From Baseline in Lipoprotein (a) at Week 36
time frame: Baseline, Week 36
description: Adjusted mean and SE at Week 36 were obtained from robust regression model including treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]) as fixed categorical effect, and baseline Lp(a) value as continuous fixed covariate.
measure: Absolute Change From Baseline in High-density Lipoprotein Cholesterol at Week 36
time frame: Baseline, Week 36
description: Adjusted LS mean and SE at Week 36 were obtained from mixed-effect model including all available post-baseline data from Week 4 to Week 36. Model included treatment arm (SoC arm, alirocumab arm), randomization strata (statin at ACS onset [Yes / No]), time point, treatment-by-time point and randomization strata-by-time point interaction as fixed categorical effects, and baseline HDL-C value and baseline HDL-C value-by-time point interaction as continuous fixed covariates.
measure: Percent Change From Baseline in High-density Lipoprotein Cholesterol at Week 36
time frame: Baseline, Week 36
description: Adjusted LS mean and SE at Week 36 were obtained from mixed-effect model including all available post-baseline data from Week 4 to Week 36. Model included treatment arm (SoC arm, alirocumab arm), randomization strata (statin at ACS onset [Yes / No]), time point, treatment-by-time point and randomization strata-by-time point interaction as fixed categorical effects, and baseline HDL-C value and baseline HDL-C value-by-time point interaction as continuous fixed covariates.
measure: Absolute Change From Baseline in Fasting Triglycerides (TGs) at Week 36
time frame: Baseline, Week 36
description: Adjusted mean and SE were obtained from multiple imputation approach followed by robust regression model including fixed categorical effect of treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]) and the continuous fixed covariate of baseline fasting TGs value.
measure: Percent Change From Baseline in Fasting Triglycerides at Week 36
time frame: Baseline, Week 36
description: Adjusted mean and SE were obtained by multiple imputation approach followed by robust regression model included fixed categorical effect of treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]) and the continuous fixed covariate of baseline fasting TGs value.
measure: Absolute Change From Baseline in Apolipoprotein A-1 (Apo A-1) at Week 36
time frame: Baseline, Week 36
description: Adjusted LS mean and SE at Week 36 were obtained from ANCOVA model including treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]) as fixed categorical effects, and baseline Apo A-1 value as continuous fixed covariate.
measure: Percent Change From Baseline in Apolipoprotein A-1 at Week 36
time frame: Baseline, Week 36
description: Adjusted LS mean and SE at Week 36 were obtained from ANCOVA model including treatment arm (SoC arm, alirocumab arm) and randomization strata (statin at ACS onset [Yes / No]) as fixed categorical effects, and baseline Apo A-1 value as continuous fixed covariate.
measure: Number of Participants With Cardiovascular (CV) Adverse Events
time frame: Up to 36 weeks
description: The suspected or confirmed CV events that occurred from randomization until end of the study visit were collected and reported. The various CV events included CV death, myocardial infarction, ischemic stroke, unstable angina requiring hospitalization , congestive heart failure requiring hospitalization, congestive heart failure requiring hospitalization, ischemia-driven coronary revascularization procedure.
arm group label: Standard of Care
arm group type: Active Comparator
description: Statin therapy (atorvastatin or rosuvastatin) will be administered with or without non-statin lipid modifying therapies (LMTs). Non-statin LMTs will be adjusted by physicians to achieve the LDL-C target level <100 milligrams per deciliter (mg/dL).
arm group label: Alirocumab
arm group type: Experimental
description: Alirocumab will be given subcutaneously every 2 weeks on top of stable dose statin therapy (atorvastatin or rosuvastatin) with or without stable dose non-statin LMTs.
intervention type: Drug
intervention name: Alirocumab SAR236553
description: Pharmaceutical form: Solution for injection
Route of administration: Subcutaneous
arm group label: Alirocumab
other name: Praluent
intervention type: Drug
intervention name: Atorvastatin
description: Pharmaceutical form: tablet
Route of administration: oral
arm group label: Alirocumab
arm group label: Standard of Care
intervention type: Drug
intervention name: Rosuvastatin
description: Pharmaceutical form: tablet
Route of administration: oral
arm group label: Alirocumab
arm group label: Standard of Care
intervention type: Drug
intervention name: Fenofibrate
description: Pharmaceutical form: tablet
Route of administration: oral
arm group label: Alirocumab
arm group label: Standard of Care
intervention type: Drug
intervention name: Bezafibrate
description: Pharmaceutical form: tablet
Route of administration: oral
arm group label: Alirocumab
arm group label: Standard of Care
intervention type: Drug
intervention name: Ezetimibe
description: Pharmaceutical form: tablet
Route of administration: oral
arm group label: Alirocumab
arm group label: Standard of Care
intervention type: Drug
intervention name: Antiplatelets
description: Pharmaceutical form: tablet or capsule
Route of administration: oral
arm group label: Alirocumab
arm group label: Standard of Care
intervention type: Drug
intervention name: Anticoagulants
description: Pharmaceutical form: tablet or capsule
Route of administration: oral
arm group label: Alirocumab
arm group label: Standard of Care
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Clinical Sciences & Operations
role: Study Director
affiliation: Sanofi
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Japan
responsible party type: Sponsor
mesh term: Acute Coronary Syndrome
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
mesh term: Hypercholesterolemia
mesh term: Syndrome
mesh term: Plaque, Atherosclerotic
mesh term: Anticoagulants
mesh term: Atorvastatin
mesh term: Rosuvastatin Calcium
mesh term: Ezetimibe
mesh term: Alirocumab
mesh term: Fenofibrate
mesh term: Bezafibrate
sharing ipd: No
ipd description: Not available for request.
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 