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

Completed · Phase 3 · Has a placebo group

Conditions studied: Atherosclerotic Cardiovascular Disease

In brief

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.

Key facts

Study ID

NCT01663402

Run by

Sanofi

People needed

18924

Starts

2012-10-01

Expected to finish

2018-01-23

Last updated by the study team

2019-03-18

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Recently (< 52 weeks) hospitalized for ACS.

You may not qualify if…

• 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.

Where it is running

• 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
• Investigational Site Number 840139 — Banning, California, United States
• Investigational Site Number 840286 — Beverly Hills, California, United States
• Investigational Site Number 840246 — Beverly Hills, California, United States
• Investigational Site Number 840353 — Beverly Hills, California, United States
• Investigational Site Number 840341 — Carmichael, California, United States
• Investigational Site Number 840299 — Chula Vista, California, United States
• Investigational Site Number 840164 — Fresno, California, United States
• Investigational Site Number 840076 — Fullerton, California, United States
• Investigational Site Number 840073 — Huntington Beach, California, United States
• Investigational Site Number 840092 — La Jolla, California, United States
• Investigational Site Number 840208 — Long Beach, California, United States
• Investigational Site Number 840068 — Long Beach, California, United States
• Investigational Site Number 840269 — Los Alamitos, California, United States
• Investigational Site Number 840009 — Los Angeles, California, United States
• Investigational Site Number 840282 — Los Angeles, California, United States
• Investigational Site Number 840163 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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