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

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.

Conditions

• Atherosclerotic Cardiovascular Disease

Interventions

DRUG

Alirocumab

Alirocumab administered as SC injection of 1 mL in the abdomen or thigh with a disposable auto-injector.

DRUG

Placebo

Placebo matched to alirocumab administered as a SC injection of 1 mL in the abdomen or thigh with a disposable auto-injector.

DRUG

LMT

Statins (atorvastatin or rosuvastatin) at stable maximal tolerated dose of statin with or without other LMT as clinically indicated.

Sponsors & Collaborators

• Regeneron Pharmaceuticals

  collaborator INDUSTRY

• Sanofi

  lead INDUSTRY

Principal Investigators

• Clinical Sciences & Operations · Sanofi

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-10-31

Primary Completion

2018-01-23

Completion

2018-01-23

Countries

• United States
• Argentina
• Australia
• Austria
• Belgium
• Bosnia and Herzegovina
• Brazil
• Bulgaria
• Canada
• Chile
• China
• Colombia
• Croatia
• Czechia
• Denmark
• Estonia
• Finland
• France
• Georgia
• Germany
• Greece
• Guatemala
• Hong Kong
• Hungary
• India
• Israel
• Italy
• Japan
• Latvia
• Lithuania
• Malaysia
• Mexico
• Netherlands
• New Zealand
• North Macedonia
• Norway
• Peru
• Philippines
• Poland
• Portugal
• Romania
• Russia
• Serbia
• Singapore
• Slovakia
• Slovenia
• South Africa
• South Korea
• Spain
• Sri Lanka
• Sweden
• Switzerland
• Taiwan
• Thailand
• Turkey (Türkiye)
• Ukraine
• United Kingdom

Study Locations