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

NCT01663402

CompletedPhase 3

Sponsor: Sanofi

Conditions: Atherosclerotic Cardiovascular Disease

Interventions: Alirocumab, Placebo, LMT

Countries: United States, Argentina, Australia, Austria, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria

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.

Eligibility overview

Sex: ALL

Age: 40 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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.
Locations (1388)
  • Birmingham, Alabama, United States
  • Birmingham, Alabama, United States
  • Huntsville, Alabama, United States
  • Huntsville, Alabama, United States
  • Mobile, Alabama, United States
  • Mobile, Alabama, United States
  • Atlantis, Arizona, United States
  • Newport Beach, Arizona, United States
  • Tucson, Arizona, United States
  • Tucson, Arizona, United States
  • Banning, California, United States
  • Beverly Hills, California, United States
  • Beverly Hills, California, United States
  • Beverly Hills, California, United States
  • Carmichael, California, United States
  • Chula Vista, California, United States
  • Fresno, California, United States
  • Fullerton, California, United States
  • Huntington Beach, California, United States
  • La Jolla, California, United States
  • Long Beach, California, United States
  • Long Beach, California, United States
  • Los Alamitos, California, United States
  • Los Angeles, California, United States
  • Los Angeles, California, United States
  • Mission Viejo, California, United States
  • Moreno Valley, California, United States
  • Northridge, California, United States
  • Pasadena, California, United States
  • Pasadena, California, United States
  • + 1358 more on CT.gov