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A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Effect of Alirocumab (SAR236553/REGN727) on the Occurrence of Cardiovascular Events in Patients Who Have Recently Experienced an Acute Coronary Syndrome
Primary Objective: To compare the effect of alirocumab with placebo on the occurrence of cardiovascular (CV) events (composite endpoint of coronary heart disease (CHD) death, non-fatal myocardial infarction (MI), fatal and non-fatal ischemic stroke, unstable angina (UA) requiring hospitalization) in participants who experienced an acute coronary syndrome (ACS) event 4 to 52 weeks prior to randomization and were 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, CHD deaths, CV deaths, all cause mortality). * To evaluate the safety and tolerability of alirocumab. * To evaluate the effect of alirocumab on lipid parameters.
18924 number of participants aged \>= 40 years old were randomized in the study.
Age
40 - No limit years
Sex
ALL
Healthy Volunteers
No
Investigational Site Number 840163
Birmingham, Alabama, United States
Investigational Site Number 840060
Birmingham, Alabama, United States
Investigational Site Number 840117
Huntsville, Alabama, United States
Investigational Site Number 840192
Huntsville, Alabama, United States
Investigational Site Number 840121
Mobile, Alabama, United States
Investigational Site Number 840319
Mobile, Alabama, United States
Investigational Site Number 840332
Atlantis, Arizona, United States
Investigational Site Number 840320
Newport Beach, Arizona, United States
Investigational Site Number 840103
Tucson, Arizona, United States
Investigational Site Number 840084
Tucson, Arizona, United States
Start Date
October 1, 2012
Primary Completion Date
January 23, 2018
Completion Date
January 23, 2018
Last Updated
March 18, 2019
18,924
ACTUAL participants
Alirocumab
DRUG
Placebo
DRUG
LMT
DRUG
Lead Sponsor
Sanofi
Collaborators
NCT06813911
NCT06295679
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06571162