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

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.

Conditions

• Hypercholesterolemia
• Acute Coronary Syndrome

Interventions

DRUG

Alirocumab SAR236553

Pharmaceutical form: Solution for injection Route of administration: Subcutaneous

DRUG

Atorvastatin

Pharmaceutical form: tablet Route of administration: oral

DRUG

Rosuvastatin

Pharmaceutical form: tablet Route of administration: oral

DRUG

Fenofibrate

Pharmaceutical form: tablet Route of administration: oral

DRUG

Bezafibrate

Pharmaceutical form: tablet Route of administration: oral

DRUG

Ezetimibe

Pharmaceutical form: tablet Route of administration: oral

DRUG

Antiplatelets

Pharmaceutical form: tablet or capsule Route of administration: oral

DRUG

Anticoagulants

Pharmaceutical form: tablet or capsule Route of administration: oral

Sponsors & Collaborators

• Regeneron Pharmaceuticals

  collaborator INDUSTRY

• Sanofi

  lead INDUSTRY

Principal Investigators

• Clinical Sciences & Operations · Sanofi

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

20 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-11-15

Primary Completion

2018-07-27

Completion

2018-07-27

Countries

• Japan

Study Locations