<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/NCT03287609</url>
  </required_header>
  <id_info>
    <org_study_id>2017-01753</org_study_id>
    <nct_id>NCT03287609</nct_id>
  </id_info>
  <brief_title>EVOlocumab for Early Reduction of LDL-cholesterol Levels in Patients With Acute Coronary Syndromes (EVOPACS)</brief_title>
  <acronym>EVOPACS</acronym>
  <official_title>EVOlocumab for Early Reduction of LDL-cholesterol Levels in Patients With Acute Coronary Syndromes (EVOPACS) - A Randomized, Double-blind, Placebo-controlled Multicenter Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Insel Gruppe AG, University Hospital Bern</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Amgen</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Bern</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Insel Gruppe AG, University Hospital Bern</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Reduction of low-density lipoprotein cholesterol (LDL-C) levels effectively reduces the risk&#xD;
      of adverse events in patients with established atherosclerotic cardiovascular disease. The&#xD;
      clinical benefit of statins in improving clinical outcomes is proportional to the magnitude&#xD;
      of LDL-C reduction, is more pronounced in patients with acute coronary syndromes (ACS)&#xD;
      compared with stable coronary artery disease, and emerges at very early stages (as early as 4&#xD;
      weeks) after ACS when statins are administered in the acute phase of the event. On the basis&#xD;
      of this evidence, early initiation of statin therapy is currently recommended in patients&#xD;
      presenting with ACS. Because many patients cannot achieve adequate reduction of LDL-C levels&#xD;
      despite treatment with high doses of statins or non-statin lipid-modifying medications,&#xD;
      substantial residual risk remains. Moreover, the time of onset of LDL-C reduction takes 2&#xD;
      weeks following initiation of statin therapy. Proprotein convertase subtilisin/kexin type-9&#xD;
      (PCSK9) inhibitors represent a novel class of lipid-lowering drugs leading to rapid,&#xD;
      profound, and consistent reductions in LDL-C levels. While the effectiveness of PCSK9&#xD;
      monoclonal antibodies for LDL-C lowering has been established across patient populations&#xD;
      without atherosclerotic cardiovascular disease or with stable ischemic heart disease,&#xD;
      reduction and attainment of LDL-C target levels has not been explored in the acute setting of&#xD;
      ACS - a clinical setting with highest risk of early event recurrence (within the first&#xD;
      month). In this study the investigators want to evaluate the safety and effectiveness of the&#xD;
      PCSK9 inhibitor evolocumab as compared with placebo, administered in the acute phase of ACS,&#xD;
      for reduction of LDL-C levels within 8 weeks in patients receiving guideline-recommended&#xD;
      high-intensity statin treatment (atorvastatin 40mg QD).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 23, 2018</start_date>
  <completion_date type="Actual">August 7, 2019</completion_date>
  <primary_completion_date type="Actual">May 20, 2019</primary_completion_date>
  <phase>Phase 3</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percent change in calculated LDL-C in the intent to treat (ITT) population</measure>
    <time_frame>Baseline to week 8</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of patients with adverse events and serious adverse events</measure>
    <time_frame>Baseline to week 8</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Nominal change in calculated LDL-C</measure>
    <time_frame>Baseline to week 8</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Proportion of patients with LDL-C level &lt;70 mg/dL (&lt;1.8 mmol/L) at week 8</measure>
    <time_frame>Baseline to week 8</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change in total cholesterol in the ITT population</measure>
    <time_frame>Baseline to week 8</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change in HDL-C in the ITT population</measure>
    <time_frame>Baseline to week 8</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change in lipoprotein-a in the ITT population</measure>
    <time_frame>Baseline to week 8</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change in triglycerides in the ITT population</measure>
    <time_frame>Baseline to week 8</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change in non-HDL-C in the ITT population</measure>
    <time_frame>Baseline to week 8</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change in apolipoprotein B in the ITT population</measure>
    <time_frame>Baseline to week 8</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change in apolipoprotein A-1 in the ITT population</measure>
    <time_frame>Baseline to week 8</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Percent change in high-sensitivity CRP (hs-CRP) in the ITT population</measure>
    <time_frame>Baseline to week 8</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Proportion of patients with hs-CRP level &lt;2 mg/dL at week 8 in the ITT population</measure>
    <time_frame>Baseline to week 8</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Proportion of patients with LDL-C &lt;70 mg/dL and hs-CRP &lt;2 mg/dL at week 8 in the ITT population</measure>
    <time_frame>Baseline to week 8</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Nominal change in Interleukin (IL)-1b and IL-6 in the ITT population</measure>
    <time_frame>Baseline to week 8</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Change in high-sensitivity Troponin T</measure>
    <time_frame>Baseline to 72 hours</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Area under the curve (AUC) at Multiplate with Adenosinediphosphate (ADP) test</measure>
    <time_frame>Baseline to 72 hours and to week 8</time_frame>
    <description>Platelet inhibition assessed with Multiplate ADP test at 72 hours and 8 weeks</description>
  </other_outcome>
  <other_outcome>
    <measure>Area under the curve (AUC) at Multiplate with Thrombin receptor activating peptide (TRAP) test</measure>
    <time_frame>Baseline to 72 hours and to week 8</time_frame>
    <description>Platelet inhibition assessed with Multiplate TRAP test at 72 hours and 8 weeks</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of patients with contrast-induced acute kidney injury (CI-AKI) at 72 hours among patients who undergo coronary angiography at baseline</measure>
    <time_frame>Baseline to 72 hours</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Number of patients with adjudicated events (death, cardiovascular death, myocardial infarction, hospitalization for recurrent ACS, hospitalization for heart failure, coronary revascularization, stroke</measure>
    <time_frame>Baseline to week 8</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">308</enrollment>
  <condition>Acute Coronary Syndrome</condition>
  <arm_group>
    <arm_group_label>Evolocumab</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Evolocumab 140 mg/mL, pre-filled auto-injector pen, 3 injections at day 1 and week 4</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo, pre-filled auto-injector pen, 3 injections at day 1 and week 4</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Evolocumab 140 mg/mL</intervention_name>
    <description>Three injections with pre-filled auto-injector pen at day 1 and at week 4.</description>
    <arm_group_label>Evolocumab</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Three injections with pre-filled auto-injector pen at day 1 and at week 4.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Male or female ≥ 18 years of age;&#xD;
&#xD;
          -  Hospitalized for a recent ACS;&#xD;
&#xD;
          -  LDL-C levels defined as follows:&#xD;
&#xD;
          -  LDL-C ≥70 mg/dL (≥1.8 mmol/L) or non-HDL-C ≥100 mg/dL (≥2.6 mmol/) in patients who&#xD;
             have been receiving stable treatment with high-intensity statin within ≥ 4 weeks prior&#xD;
             to enrollment (i.e. continuous treatment that has not changed with regard to statin&#xD;
             intensity over the past 4 weeks) or, LDL-C ≥90 mg/dL (≥2.3 mmol/L) or non-HDL-C ≥120&#xD;
             mg/dL (≥3.1 mmol/) in patients who have been receiving stable treatment with low- or&#xD;
             moderate-intensity statin within ≥ 4 weeks prior to enrollment (i.e. continuous&#xD;
             treatment that has not changed with regard to statin intensity over the past 4 weeks),&#xD;
             or LDL-C ≥125 mg/dL (≥3.2 mmol/L) or non-HDL-C ≥155 mg/dL (≥4.0 mmol/) in patients who&#xD;
             are statin-naïve or have not been on a stable (unchanged) statin regimen for at least&#xD;
             4 weeks prior to enrollment;&#xD;
&#xD;
          -  Ability to understand the requirements of the study and to provide informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unstable clinical status (hemodynamic or electrical instability;&#xD;
&#xD;
          -  Uncontrolled cardiac arrhythmia, defined as recurrent and symptomatic ventricular&#xD;
             tachycardia or atrial fibrillation with rapid ventricular response not controlled by&#xD;
             medications in the past 3 months prior to screening;&#xD;
&#xD;
          -  Severe renal dysfunction, defined by estimated glomerular filtration rate &lt;30&#xD;
             ml/min/1.73m2;&#xD;
&#xD;
          -  Active liver disease or hepatic dysfunction, either reported in patient medical record&#xD;
             or defined by asparate aminotransferase (AST) or alanine aminotransferase (ALT) levels&#xD;
             &gt; 3x the upper limit of normal;&#xD;
&#xD;
          -  Reported intolerance to atorvastatin (any dose) OR statin intolerance;&#xD;
&#xD;
          -  Known allergy to contrast medium, heparin, aspirin, ticagrelor or prasugrel;&#xD;
&#xD;
          -  Known sensitivity to any substances to be administered;&#xD;
&#xD;
          -  Patients who previously received evolocumab or other PCSK9 inhibitor;&#xD;
&#xD;
          -  Patient who received cholesterol ester transfer protein inhibitors in the past 12&#xD;
             months prior to screening;&#xD;
&#xD;
          -  Treatment with systemic steroids or systemic cyclosporine in the past 3 months&#xD;
             systemic cyclosporine, systemic steroids (eg. intravenous, intramuscular or per os);&#xD;
&#xD;
          -  Known active infection or major hematologic, metabolic, or endocrine dysfunction in&#xD;
             the judgment of the Investigator;&#xD;
&#xD;
          -  Patients who will not be available for study-required procedures in the judgment of&#xD;
             the Investigator;&#xD;
&#xD;
          -  Current enrollment in another investigational device or drug study;&#xD;
&#xD;
          -  Active malignancy requiring treatment;&#xD;
&#xD;
          -  Female of childbearing potential (age &lt;50 years and last menstruation within the last&#xD;
             12 months), who did not undergo tubal ligation, ovariectomy or hysterectomy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stephan Windecker, Prof., MD</last_name>
    <role>Study Chair</role>
    <affiliation>Bern University Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Konstantinos Koskinas, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Bern University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Basel University Hospital</name>
      <address>
        <city>Basel</city>
        <state>BS</state>
        <zip>4031</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HFR Kantonsspital</name>
      <address>
        <city>Fribourg</city>
        <state>FR</state>
        <zip>1708</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopitaux Universitaires Geneve</name>
      <address>
        <city>Geneva</city>
        <state>GE</state>
        <zip>1211</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiocentro Ticino</name>
      <address>
        <city>Lugano</city>
        <state>TI</state>
        <zip>6900</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire Vaudois</name>
      <address>
        <city>Lausanne</city>
        <state>VD</state>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital</name>
      <address>
        <city>Zurich</city>
        <state>ZH</state>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bern University Hospital</name>
      <address>
        <city>Bern</city>
        <zip>3010</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <results_reference>
    <citation>Sabatine MS, Giugliano RP, Keech AC, Honarpour N, Wiviott SD, Murphy SA, Kuder JF, Wang H, Liu T, Wasserman SM, Sever PS, Pedersen TR; FOURIER Steering Committee and Investigators. Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease. N Engl J Med. 2017 May 4;376(18):1713-1722. doi: 10.1056/NEJMoa1615664. Epub 2017 Mar 17.</citation>
    <PMID>28304224</PMID>
  </results_reference>
  <results_reference>
    <citation>Lipinski MJ, Benedetto U, Escarcega RO, Biondi-Zoccai G, Lhermusier T, Baker NC, Torguson R, Brewer HB Jr, Waksman R. The impact of proprotein convertase subtilisin-kexin type 9 serine protease inhibitors on lipid levels and outcomes in patients with primary hypercholesterolaemia: a network meta-analysis. Eur Heart J. 2016 Feb 7;37(6):536-45. doi: 10.1093/eurheartj/ehv563. Epub 2015 Nov 17.</citation>
    <PMID>26578202</PMID>
  </results_reference>
  <results_reference>
    <citation>Ray KK, Cannon CP, McCabe CH, Cairns R, Tonkin AM, Sacks FM, Jackson G, Braunwald E; PROVE IT-TIMI 22 Investigators. Early and late benefits of high-dose atorvastatin in patients with acute coronary syndromes: results from the PROVE IT-TIMI 22 trial. J Am Coll Cardiol. 2005 Oct 18;46(8):1405-10. doi: 10.1016/j.jacc.2005.03.077.</citation>
    <PMID>16226162</PMID>
  </results_reference>
  <results_reference>
    <citation>Schwartz GG, Olsson AG, Ezekowitz MD, Ganz P, Oliver MF, Waters D, Zeiher A, Chaitman BR, Leslie S, Stern T; Myocardial Ischemia Reduction with Aggressive Cholesterol Lowering (MIRACL) Study Investigators. Effects of atorvastatin on early recurrent ischemic events in acute coronary syndromes: the MIRACL study: a randomized controlled trial. JAMA. 2001 Apr 4;285(13):1711-8. doi: 10.1001/jama.285.13.1711.</citation>
    <PMID>11277825</PMID>
  </results_reference>
  <results_reference>
    <citation>Navarese EP, Kolodziejczak M, Kereiakes DJ, Tantry US, O'Connor C, Gurbel PA. Proprotein Convertase Subtilisin/Kexin Type 9 Monoclonal Antibodies for Acute Coronary Syndrome: A Narrative Review. Ann Intern Med. 2016 May 3;164(9):600-7. doi: 10.7326/M15-2994. Epub 2016 Mar 22.</citation>
    <PMID>26999484</PMID>
  </results_reference>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>September 7, 2017</study_first_submitted>
  <study_first_submitted_qc>September 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 19, 2017</study_first_posted>
  <last_update_submitted>August 13, 2019</last_update_submitted>
  <last_update_submitted_qc>August 13, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 14, 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>Syndrome</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Evolocumab</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No plan to make individual participant data available to other researchers</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03287609
org study id: 2017-01753
nct id: NCT03287609
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Reduction of low-density lipoprotein cholesterol (LDL-C) levels effectively reduces the risk
      of adverse events in patients with established atherosclerotic cardiovascular disease. The
      clinical benefit of statins in improving clinical outcomes is proportional to the magnitude
      of LDL-C reduction, is more pronounced in patients with acute coronary syndromes (ACS)
      compared with stable coronary artery disease, and emerges at very early stages (as early as 4
      weeks) after ACS when statins are administered in the acute phase of the event. On the basis
      of this evidence, early initiation of statin therapy is currently recommended in patients
      presenting with ACS. Because many patients cannot achieve adequate reduction of LDL-C levels
      despite treatment with high doses of statins or non-statin lipid-modifying medications,
      substantial residual risk remains. Moreover, the time of onset of LDL-C reduction takes 2
      weeks following initiation of statin therapy. Proprotein convertase subtilisin/kexin type-9
      (PCSK9) inhibitors represent a novel class of lipid-lowering drugs leading to rapid,
      profound, and consistent reductions in LDL-C levels. While the effectiveness of PCSK9
      monoclonal antibodies for LDL-C lowering has been established across patient populations
      without atherosclerotic cardiovascular disease or with stable ischemic heart disease,
      reduction and attainment of LDL-C target levels has not been explored in the acute setting of
      ACS - a clinical setting with highest risk of early event recurrence (within the first
      month). In this study the investigators want to evaluate the safety and effectiveness of the
      PCSK9 inhibitor evolocumab as compared with placebo, administered in the acute phase of ACS,
      for reduction of LDL-C levels within 8 weeks in patients receiving guideline-recommended
      high-intensity statin treatment (atorvastatin 40mg QD).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Percent change in calculated LDL-C in the intent to treat (ITT) population
time frame: Baseline to week 8
measure: Number of patients with adverse events and serious adverse events
time frame: Baseline to week 8
measure: Nominal change in calculated LDL-C
time frame: Baseline to week 8
measure: Proportion of patients with LDL-C level <70 mg/dL (<1.8 mmol/L) at week 8
time frame: Baseline to week 8
measure: Change in total cholesterol in the ITT population
time frame: Baseline to week 8
measure: Change in HDL-C in the ITT population
time frame: Baseline to week 8
measure: Change in lipoprotein-a in the ITT population
time frame: Baseline to week 8
measure: Change in triglycerides in the ITT population
time frame: Baseline to week 8
measure: Change in non-HDL-C in the ITT population
time frame: Baseline to week 8
measure: Change in apolipoprotein B in the ITT population
time frame: Baseline to week 8
measure: Change in apolipoprotein A-1 in the ITT population
time frame: Baseline to week 8
measure: Percent change in high-sensitivity CRP (hs-CRP) in the ITT population
time frame: Baseline to week 8
measure: Proportion of patients with hs-CRP level <2 mg/dL at week 8 in the ITT population
time frame: Baseline to week 8
measure: Proportion of patients with LDL-C <70 mg/dL and hs-CRP <2 mg/dL at week 8 in the ITT population
time frame: Baseline to week 8
measure: Nominal change in Interleukin (IL)-1b and IL-6 in the ITT population
time frame: Baseline to week 8
measure: Change in high-sensitivity Troponin T
time frame: Baseline to 72 hours
measure: Area under the curve (AUC) at Multiplate with Adenosinediphosphate (ADP) test
time frame: Baseline to 72 hours and to week 8
description: Platelet inhibition assessed with Multiplate ADP test at 72 hours and 8 weeks
measure: Area under the curve (AUC) at Multiplate with Thrombin receptor activating peptide (TRAP) test
time frame: Baseline to 72 hours and to week 8
description: Platelet inhibition assessed with Multiplate TRAP test at 72 hours and 8 weeks
measure: Number of patients with contrast-induced acute kidney injury (CI-AKI) at 72 hours among patients who undergo coronary angiography at baseline
time frame: Baseline to 72 hours
measure: Number of patients with adjudicated events (death, cardiovascular death, myocardial infarction, hospitalization for recurrent ACS, hospitalization for heart failure, coronary revascularization, stroke
time frame: Baseline to week 8
arm group label: Evolocumab
arm group type: Active Comparator
description: Evolocumab 140 mg/mL, pre-filled auto-injector pen, 3 injections at day 1 and week 4
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo, pre-filled auto-injector pen, 3 injections at day 1 and week 4
intervention type: Drug
intervention name: Evolocumab 140 mg/mL
description: Three injections with pre-filled auto-injector pen at day 1 and at week 4.
arm group label: Evolocumab
intervention type: Drug
intervention name: Placebo
description: Three injections with pre-filled auto-injector pen at day 1 and at week 4.
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Stephan Windecker, Prof., MD
role: Study Chair
affiliation: Bern University Hospital
last name: Konstantinos Koskinas, MD
role: Principal Investigator
affiliation: Bern University Hospital
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Switzerland
citation: Sabatine MS, Giugliano RP, Keech AC, Honarpour N, Wiviott SD, Murphy SA, Kuder JF, Wang H, Liu T, Wasserman SM, Sever PS, Pedersen TR; FOURIER Steering Committee and Investigators. Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease. N Engl J Med. 2017 May 4;376(18):1713-1722. doi: 10.1056/NEJMoa1615664. Epub 2017 Mar 17.
PMID: 28304224
citation: Lipinski MJ, Benedetto U, Escarcega RO, Biondi-Zoccai G, Lhermusier T, Baker NC, Torguson R, Brewer HB Jr, Waksman R. The impact of proprotein convertase subtilisin-kexin type 9 serine protease inhibitors on lipid levels and outcomes in patients with primary hypercholesterolaemia: a network meta-analysis. Eur Heart J. 2016 Feb 7;37(6):536-45. doi: 10.1093/eurheartj/ehv563. Epub 2015 Nov 17.
PMID: 26578202
citation: Ray KK, Cannon CP, McCabe CH, Cairns R, Tonkin AM, Sacks FM, Jackson G, Braunwald E; PROVE IT-TIMI 22 Investigators. Early and late benefits of high-dose atorvastatin in patients with acute coronary syndromes: results from the PROVE IT-TIMI 22 trial. J Am Coll Cardiol. 2005 Oct 18;46(8):1405-10. doi: 10.1016/j.jacc.2005.03.077.
PMID: 16226162
citation: Schwartz GG, Olsson AG, Ezekowitz MD, Ganz P, Oliver MF, Waters D, Zeiher A, Chaitman BR, Leslie S, Stern T; Myocardial Ischemia Reduction with Aggressive Cholesterol Lowering (MIRACL) Study Investigators. Effects of atorvastatin on early recurrent ischemic events in acute coronary syndromes: the MIRACL study: a randomized controlled trial. JAMA. 2001 Apr 4;285(13):1711-8. doi: 10.1001/jama.285.13.1711.
PMID: 11277825
citation: Navarese EP, Kolodziejczak M, Kereiakes DJ, Tantry US, O'Connor C, Gurbel PA. Proprotein Convertase Subtilisin/Kexin Type 9 Monoclonal Antibodies for Acute Coronary Syndrome: A Narrative Review. Ann Intern Med. 2016 May 3;164(9):600-7. doi: 10.7326/M15-2994. Epub 2016 Mar 22.
PMID: 26999484
responsible party type: Sponsor
mesh term: Acute Coronary Syndrome
mesh term: Syndrome
mesh term: Evolocumab
sharing ipd: No
ipd description: No plan to make individual participant data available to other researchers