A study of SAR236553/REGN727 in patients with Acute Coronary Syndrome
Research type
Research Study
Full title
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
IRAS ID
114081
Contact name
Kausik Ray
Contact email
Sponsor organisation
sanofi-aventis Recherche & Développement
Eudract number
2011-005698-21
Clinicaltrials.gov Identifier
Research summary
Patients with recent acute coronary syndrome (ACS) are at high risk of recurrent coronary events in the near future and in approximately 10% of these patients, cardiovascular (CV) death, recurrent myocardial infarction, or stroke occurs within 1 year. Based on results from past clinical trials, a strong linear relationship between the levels of low-density lipoprotein cholesterol (LDL-C) and CV events has been demonstrated and early intensive statin therapy has become formally approved as a treatment recommendation for patients with ACS. However, there are still many high CV risk patients who cannot achieve the desired levels of LDL-C with currently available lipid-lowering drugs. This Phase 3b, randomised, double-blind, placebo-controlled study has been designed to compare the effect of SAR236553 (study drug) with placebo on the occurrence of CV events in patients who have experienced an ACS event 4 to 16 weeks prior to randomisation and are treated with intensive statin therapy or at maximally tolerated dose of these given statins, or other non-statin lipid modifying therapy.The study will consist of three periods; a run-in period during which the background LMT will be adjusted so that the patient receives the required intensive statin treatment or the maximally tolerated doses of these given statins, or other non-statin LMTs prior to randomization; a double-blind treatment period during which the background LMT will not be modified, whilst the patient receives SAR236553 or placebo (randomised in a 1:1 ratio); and a follow-up contact 8 weeks after the final visit that corresponds to the common study end date. 18000 male and female patients aged over 40 years of age, who have been hospitalised for ACS and whose lipid levels are not adequately controlled at the time of randomisation will be eligible for this study. Patients are expected to be part of the study for approximately 5 years.
REC name
West of Scotland REC 1
REC reference
12/WS/0300
Date of REC Opinion
5 Mar 2013
REC opinion
Further Information Favourable Opinion