Evaluation of Effect of Alirocumab on Coronary Atheroma Volume in Japanese Patients Hospitalized for Acute Coronary Syndrome With Hypercholesterolemia

Sponsor
Sanofi
Study ID
NCT02984982
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Alirocumab SAR236553 — DRUG
    Pharmaceutical form: Solution for injection Route of administration: Subcutaneous
  • Atorvastatin — DRUG
    Pharmaceutical form: tablet Route of administration: oral
  • Rosuvastatin — DRUG
    Pharmaceutical form: tablet Route of administration: oral
  • Fenofibrate — DRUG
    Pharmaceutical form: tablet Route of administration: oral
  • Bezafibrate — DRUG
    Pharmaceutical form: tablet Route of administration: oral
  • Ezetimibe — DRUG
    Pharmaceutical form: tablet Route of administration: oral
  • Antiplatelets — DRUG
    Pharmaceutical form: tablet or capsule Route of administration: oral
  • Anticoagulants — DRUG
    Pharmaceutical form: tablet or capsule Route of administration: oral

Study Details

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.

Key Dates

Start date
Nov 15, 2016
Status verified
Jul 2019
Primary completion
Jul 27, 2018
Completion
Jul 27, 2018

Study Design

Enrollment
206 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Standard of Care
    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).
  • Experimental: Alirocumab
    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.

Primary Outcome Measure

Percent Change From Baseline in Normalized Total Atheroma Volume (TAV) at Week 36 [ Time Frame: Baseline, Week 36 ]

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