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Clinical Trial Summary

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.


Clinical Trial Description

18924 number of participants aged >= 40 years old were randomized in the study. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01663402
Study type Interventional
Source Sanofi
Contact
Status Completed
Phase Phase 3
Start date October 2012
Completion date January 23, 2018

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