NCT02984982

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

A Randomized, Open-label, Blinded Intravascular Ultrasound Analysis, Parallel Group, Multicenter Study to Evaluate the Effect of Praluent® (Alirocumab) on Coronary Atheroma Volume in Japanese Patients Hospitalized for Acute Coronary Syndrome With Hypercholesterolemia Not Adequately Controlled With Statin

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 206 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The duration of study per participant was 9 months.

Conditions

• Hypercholesterolemia
• Acute Coronary Syndrome

Interventions

Type	Name	Description
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

Timeline

• Start date: 2016-11-15
• Primary completion: 2018-07-27
• Completion: 2018-07-27
• First posted: 2016-12-07
• Last updated: 2019-09-09
• Results posted: 2019-09-09

Locations

39 sites across 1 country: Japan