ODYSSEY Outcomes: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab



Status:Completed
Conditions:Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:40 - Any
Updated:3/20/2019
Start Date:October 2012
End Date:January 23, 2018

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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.

Inclusion criteria :

Recently (< 52 weeks) hospitalized for ACS.

Exclusion criteria:

- Age < 40 years.

- ACS event occurring more than 52 weeks prior to randomization visit.

- LDL-C likely to be <70 mg/dL (<1.81 mmo/L), and apolipoprotein B (ApoB) <80 mg/dL
(<0.8 g/L), and non - high-density lipoprotein cholesterol (HDL-C) <100 mg/dL (<2.59
mmol/L) with evidence-based medical and dietary management of dyslipidemia.

The above information is not intended to contain all considerations relevant to a
participant's potential participation in a clinical trial.
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