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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01663402
• Date of registration: 08/08/2012
• Prospective Registration: Yes
• Primary sponsor: Sanofi
• Public title: ODYSSEY Outcomes: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab
• Scientific title: 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
• Date of first enrolment: October 2012
• Target sample size: 18924
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01663402
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

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

Contacts

• Name: Clinical Sciences & Operations
• Affiliation: Sanofi

Key inclusion & exclusion 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.



Age minimum: 40 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Atherosclerotic Cardiovascular Disease

Intervention(s)

Drug: Placebo

Drug: Alirocumab

Drug: LMT

Primary Outcome(s)

Time to First Occurrence of Major Adverse Cardiovascular Event (MACE); Percentage of Observed Participants With Outcome Measure Events During the Study [Time Frame: From randomization up to 64 months]

Secondary Outcome(s)

Time to First Occurrence of Any Congestive Heart Failure (CHF) Requiring Hospitalization; Percentage of Observed Participants With Outcome Measure Events During the Study [Time Frame: From randomization up to 64 months]

Time to First Occurrence of Any Non-Fatal Myocardial Infarction; Percentage of Observed Participants With Outcome Measure Events During the Study [Time Frame: From randomization up to 64 months]

Time to Coronary Heart Disease Death; Percentage of Observed Participants With Outcome Measure Events During the Study [Time Frame: From randomization up to 64 months]

Time to First Occurrence of Any Cardiovascular Event; Percentage of Observed Participants With Outcome Measure Events During the Study [Time Frame: From randomization up to 64 months]

Time to First Occurrence of Any Coronary Heart Disease Event; Percentage of Observed Participants With Outcome Measure Events During the Study [Time Frame: From randomization up to 64 months]

Time to All-Cause Death; Percentage of Observed Participants With Outcome Measure Events During the Study [Time Frame: From randomization up to 64 months]

Time to First Occurrence of Any Major Coronary Heart Disease Event; Percentage of Observed Participants With Outcome Measure Events During the Study [Time Frame: From randomization up to 64 months]

Time to First Occurrence of All-Cause Mortality, Non-Fatal Myocardial Infarction, Non-Fatal Ischemic Stroke; Percentage of Observed Participants With Outcome Measure Events During the Study [Time Frame: From randomization up to 64 months]

Time to First Occurrence of Any Unstable Angina Requiring Hospitalization; Percentage of Observed Participants With Outcome Measure Events During the Study [Time Frame: From randomization up to 64 months]

Time to Cardiovascular Death; Percentage of Observed Participants With Outcome Measure Events During the Study [Time Frame: From randomization up to 64 months]

Time to First Occurrence of Fatal or Any Non-Fatal Ischemic Stroke; Percentage of Observed Participants With Outcome Measure Events During the Study [Time Frame: From randomization up to 64 months]

Time to First Occurrence of Any Ischemia-Driven Coronary Revascularization Procedure; Percentage of Observed Participants With Outcome Measure Events During the Study [Time Frame: From randomization up to 64 months]

Secondary ID(s)

U1111-1127-4323

2011-005698-21

EFC11570

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Regeneron Pharmaceuticals

Results

• Results available: Yes
• Date Posted: 18/03/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01663402