Evaluation of Effect of Alirocumab on Coronary Atheroma Volume in Japanese Patients Hospitalized for Acute Coronary Syndrome With Hypercholesterolemia
Condition: Hypercholesterolemia; Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome; Coronary Artery Disease; Myocardial Ischemia; Hypercholesterolemia; Syndrome; Plaque, Atherosclerotic
Intervention: Alirocumab SAR236553; Atorvastatin; Rosuvastatin; Fenofibrate; Bezafibrate; Ezetimibe; Antiplatelets; Anticoagulants
Intervention description: Pharmaceutical form: Solution for injection
Route of administration: Subcutaneous; Pharmaceutical form: tablet
Route of administration: oral; Pharmaceutical form: tablet
Route of administration: oral; Pharmaceutical form: tablet
Route of administration: oral; Pharmaceutical form: tablet
Route of administration: oral; Pharmaceutical form: tablet
Route of administration: oral; Pharmaceutical form: tablet or capsule
Route of administration: oral; Pharmaceutical form: tablet or capsule
Route of administration: oral
Intervention MeSH terms: Anticoagulants; Atorvastatin; Rosuvastatin Calcium; Ezetimibe; Alirocumab; Fenofibrate; Bezafibrate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 206.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        Inclusion criteria :

          -  Participants hospitalized for ACS (Acute ST-segment elevation myocardial infarction
             [STEMI], Acute non-ST-segment elevation myocardial infarction [NSTEMI], and unstable
             angina.

          -  LDL-C >=100 mg/dL at ACS diagnosis.

          -  Participants who has stenosis with at least >50% stenosis angiographically within 1
             week after the ACS onset, and has analyzable coronary intravascular Ultrasound image.

          -  Participants aged >=20 years old at ACS diagnosis.

          -  Negative Hepatitis B surface antigen, negative Hepatitis B core antibody, and negative
             Hepatitis C antibody. Or, negative Hepatitis B surface antigen, positive Hepatitis B
             core antibody, negative Hepatitis B deoxyribonucleic acid, and negative Hepatitis C
             antibody.

          -  Written informed consent.

        Exclusion criteria:

          -  Participants who had previously treated with at least one dose of any anti-proprotein
             convertase subtilisin/kexin type 9 monoclonal antibody.

          -  Uncontrolled hypertension (multiple reading with systolic blood pressure >180 mmHg or
             diastolic blood pressure >110 mmHg) between ACS diagnosis and randomization visit.

          -  Known history of hemorrhagic stroke.

          -  Currently under treatment for cancer.

          -  Participants on LDL apheresis.

          -  Any clinically significant abnormality identified that in the judgment of the
             Investigator or any sub-Investigator would preclude safe completion of the study or
             constrain endpoints assessment such as major systemic diseases, participants with
             short life expectancy.

          -  Considered by the Investigator or any sub-Investigator as inappropriate for this study
             for any reason, including:

               -  Unable to meet specific protocol requirements, such as scheduled visits;

               -  Investigator or any sub-Investigator, pharmacist, study coordinator, other study
                  staff or relative thereof directly involved in the conduct of the protocol, etc;

               -  Presence of any other conditions (eg, geographic, social, etc.) actual or
                  anticipated, that the Investigator feels would restrict or limit the
                  participant's participation for the duration of the study.

          -  Laboratory findings measured within 4 weeks after the ACS diagnosis (positive serum or
             urine pregnancy test in females of childbearing potential).

        The above information was not intended to contain all considerations relevant to a
        participant's potential participation in a clinical trial.