Clinical Trial Details

Overview

Research Study Summary

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Effect of SAR236553/REGN727 on the Occurrence of Cardiovascular Events in Patients Who Have Recently Experienced an Acute Coronary Syndrome

Purpose

Primary Objective:

  • To compare the effect of alirocumab with placebo on the occurrence of cardiovascular events (composite endpoint of coronary heart disease (CHD) death, non-fatal myocardial infarction (MI), fatal and non-fatal ischemic stroke, unstable angina requiring hospitalization) in patients who have experienced an acute coronary syndrome (ACS) event 4 to 52 weeks prior to randomization and are treated with evidence-based medical and dietary management of dyslipidemia.

Secondary Objectives:

  • To evaluate the effect of alirocumab on secondary endpoints (any CHD event , major CHD event, any CV event, composite of all cause mortality/non-fatal MI/non-fatal ischemic stroke, all cause mortality).
  • To evaluate the safety and tolerability of alirocumab.
  • To evaluate the effect of alirocumab on lipid parameters.

To Learn more

CW ID: 203049
Date Last Changed: November 5, 2014

Clinical Trial Snapshot

Phase
3
Gender
Both Male and Female
Age
40 and up
Overall Status
Recruiting
Lead Sponsor
Sanofi Aventis
Facility Type
N/A

Contact

Bonnie Kirby
University of South Florida - South Tampa Center for Advanced Healthcare
2 Tampa General Circle
Tampa, FL 33606
Phone: (813)259-8543

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