<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/NCT04499859</url>
  </required_header>
  <id_info>
    <org_study_id>ROSUZET-AMI</org_study_id>
    <nct_id>NCT04499859</nct_id>
  </id_info>
  <brief_title>Low Dose Rosuvastatin Plus Ezetimibe Versus High-dose Rosuvastatin in AMI</brief_title>
  <acronym>ROSUZET-AMI</acronym>
  <official_title>A Prospective, Multicenter, Randomized, Open-label Trial to Compare Low-dose ROSUvastatin Plus eZETimibe Versus High-dose Rosuvastatin in Patients With Acute Myocardial Infarction Undergoing Percutaneous Coronary Intervention</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kiyuk Chang, MD,PhD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Catholic University of Korea</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>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Combination therapy of rosuvastatin 5mg and ezetimibe 10 mg showed similar achievement rate&#xD;
      in decreasing LDL cholesterol level by 50% as single use of rosuvastatin 20 mg.&#xD;
&#xD;
      This trial aims to prove non-inferiority of concomitant usage of low dose rosuvastatin and&#xD;
      ezetimibe among patients with acute myocardial infarction who went through percutaneous&#xD;
      coronary intervention at decreasing major adverse cardiac events compared to the efficacy of&#xD;
      single use of high dose rosuvastatin.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      IMPROVE-IT (Improved Reduction of Outcomes: Vytorin Efficacy International Trial) study&#xD;
      showed that even when statin is not used as a treatment the rate of decrease of LDL&#xD;
      cholesterol is correlated to the risk of heart disease. Yet whether concomitant use of&#xD;
      ezetimibe and statin will have similar degree of clinical efficacy as single use of high dose&#xD;
      statin in decreasing LDL cholesterol level needs further examination.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 1, 2020</start_date>
  <completion_date type="Anticipated">July 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2024</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>Major Adverse Cardiovascular Events (MACE)</measure>
    <time_frame>24 months</time_frame>
    <description>A composite of cardiovascular death, non-fatal myocardial infarction, ischemic stroke and hospitalization due to unstable angina</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Each clinical outcome from MACE</measure>
    <time_frame>24 months</time_frame>
    <description>Assessment variable including cardiovascular deaths, total deaths, non-fatal myocardial infarction, non-fatal ischemic stroke, hospitalization due to unstable angina</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Revascularization</measure>
    <time_frame>24 months</time_frame>
    <description>any revascularization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>LDL-C reduction</measure>
    <time_frame>3 months</time_frame>
    <description>LDL cholesterol level of 70mg/dL or less</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of Statin associated muscle symptoms</measure>
    <time_frame>3 months</time_frame>
    <description>Stain Associated Muscle Symptom questionnaire</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">3548</enrollment>
  <condition>Myocardial Infarction</condition>
  <condition>Statin Adverse Reaction</condition>
  <condition>HMG-CoA Reductase Inhibitor Toxicity</condition>
  <arm_group>
    <arm_group_label>ezetimibe 10 mg plus rosuvastatin 5 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Rosuzet 5/10 mg , once a day for 24 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>rosuvastatin 20 mg only</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Any brand drugs of rosuvastatin 20mg, once a day for 24 months</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ezetimibe 10mg + Rosuvastatin 5mg</intervention_name>
    <description>Initial use of 10mg of ezetimibe combined with 5 mg of rosuvastatin</description>
    <arm_group_label>ezetimibe 10 mg plus rosuvastatin 5 mg</arm_group_label>
    <other_name>Rosuzet 10/5 mg</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rosuvastatin 20mg</intervention_name>
    <description>20mg of Rosuvastatin as a standard treatment for AMI patients</description>
    <arm_group_label>rosuvastatin 20 mg only</arm_group_label>
    <other_name>Crestor 20mg</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Adults Aged 19 and up&#xD;
&#xD;
          2. Patients diagnosed with myocardial infarction (both ST segment elevation and non-ST&#xD;
             segment elevation) who were treated with percutaneous coronary intervention&#xD;
             (Myocardial infarction defined as in the 4th Universal Definition of Myocardial&#xD;
             Infarction)&#xD;
&#xD;
          3. For female patients who are of childbearing age, subjects that agreed on taking&#xD;
             mandatory pregnancy test&#xD;
&#xD;
          4. Patients who agreed and signed on the informed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with life expectancy of a year or less due to malignancy&#xD;
&#xD;
          2. Patients with chronic liver disease&#xD;
&#xD;
          3. Patients with sensitivity to active ingredient of the research drugs (ezetimibe and/or&#xD;
             rosuvastatin) or patients who are prohibited to take ezetimibe and/or rosuvastatin.&#xD;
&#xD;
          4. Pregnant and/or breastfeeding&#xD;
&#xD;
          5. Female patients who are unable to use any means of contraception&#xD;
&#xD;
          6. Patients receiving hemodialysis, peritoneal dialysis patients and/or kidney transplant&#xD;
             patients, due to end stage renal disease&#xD;
&#xD;
          7. Patients who participated in other clinical trial(s) within 3 months from the&#xD;
             screening (except non-interventional observational study)&#xD;
&#xD;
          8. Patients considered inappropriate for the study for any other reason(s) by the&#xD;
             inspector(s)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kiyuk Chang, MD,PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Seoul St. Mary's Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Kiyuk Chang, MD,PhD</last_name>
    <phone>82-10-9175-2076</phone>
    <email>kiyuk@catholic.ac.kr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Eun Ho Choo, MD</last_name>
    <phone>82-10-8500-4569</phone>
    <email>cmcchu@catholic.ac.kr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Bucheon St.Mary Hospital</name>
      <address>
        <city>Bucheon</city>
        <state>Gyeonggido</state>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hee Yeol Kim, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>St.Vincent's Hospital</name>
      <address>
        <city>Suwon</city>
        <state>Gyeonggido</state>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ki-Dong Yoo, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Uijeongbu St.Mary's Hospital</name>
      <address>
        <city>Uijeongbu</city>
        <state>Gyeonggido</state>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Chan Joon Kim, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Daejeon St.Mary's Hospital</name>
      <address>
        <city>Daejeon</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Man Won Park, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Incheon St.Mary's Hospital</name>
      <address>
        <city>Incheon</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Doo Soo Jeon, M.D.</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Seoul St.Mary's Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>137-701</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Kiyuk Chang, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Yeouido St.Mary Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Chul-Soo Park, M.D.</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>July 29, 2020</study_first_submitted>
  <study_first_submitted_qc>August 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <last_update_submitted>September 2, 2022</last_update_submitted>
  <last_update_submitted_qc>September 2, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>The Catholic University of Korea</investigator_affiliation>
    <investigator_full_name>Kiyuk Chang, MD,PhD</investigator_full_name>
    <investigator_title>Professor of Medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>Infarction</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rosuvastatin Calcium</mesh_term>
    <mesh_term>Ezetimibe</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04499859
org study id: ROSUZET-AMI
nct id: NCT04499859
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: Yes
Combination therapy of rosuvastatin 5mg and ezetimibe 10 mg showed similar achievement rate
      in decreasing LDL cholesterol level by 50% as single use of rosuvastatin 20 mg.

      This trial aims to prove non-inferiority of concomitant usage of low dose rosuvastatin and
      ezetimibe among patients with acute myocardial infarction who went through percutaneous
      coronary intervention at decreasing major adverse cardiac events compared to the efficacy of
      single use of high dose rosuvastatin.
IMPROVE-IT (Improved Reduction of Outcomes: Vytorin Efficacy International Trial) study
      showed that even when statin is not used as a treatment the rate of decrease of LDL
      cholesterol is correlated to the risk of heart disease. Yet whether concomitant use of
      ezetimibe and statin will have similar degree of clinical efficacy as single use of high dose
      statin in decreasing LDL cholesterol level needs further examination.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Major Adverse Cardiovascular Events (MACE)
time frame: 24 months
description: A composite of cardiovascular death, non-fatal myocardial infarction, ischemic stroke and hospitalization due to unstable angina
measure: Each clinical outcome from MACE
time frame: 24 months
description: Assessment variable including cardiovascular deaths, total deaths, non-fatal myocardial infarction, non-fatal ischemic stroke, hospitalization due to unstable angina
measure: Revascularization
time frame: 24 months
description: any revascularization
measure: LDL-C reduction
time frame: 3 months
description: LDL cholesterol level of 70mg/dL or less
measure: Rate of Statin associated muscle symptoms
time frame: 3 months
description: Stain Associated Muscle Symptom questionnaire
arm group label: ezetimibe 10 mg plus rosuvastatin 5 mg
arm group type: Experimental
description: Rosuzet 5/10 mg , once a day for 24 months
arm group label: rosuvastatin 20 mg only
arm group type: Active Comparator
description: Any brand drugs of rosuvastatin 20mg, once a day for 24 months
intervention type: Drug
intervention name: Ezetimibe 10mg + Rosuvastatin 5mg
description: Initial use of 10mg of ezetimibe combined with 5 mg of rosuvastatin
arm group label: ezetimibe 10 mg plus rosuvastatin 5 mg
other name: Rosuzet 10/5 mg
intervention type: Drug
intervention name: Rosuvastatin 20mg
description: 20mg of Rosuvastatin as a standard treatment for AMI patients
arm group label: rosuvastatin 20 mg only
other name: Crestor 20mg
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Kiyuk Chang, MD,PhD
role: Study Chair
affiliation: Seoul St. Mary's Hospital
last name: Kiyuk Chang, MD,PhD
phone: 82-10-9175-2076
email: kiyuk@catholic.ac.kr
last name: Eun Ho Choo, MD
phone: 82-10-8500-4569
email: cmcchu@catholic.ac.kr
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Sponsor-Investigator
investigator affiliation: The Catholic University of Korea
investigator full name: Kiyuk Chang, MD,PhD
investigator title: Professor of Medicine
mesh term: Myocardial Infarction
mesh term: Infarction
mesh term: Rosuvastatin Calcium
mesh term: Ezetimibe
sharing ipd: No