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 |
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.
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.
We found this trial at
266
sites
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