ODYSSEY Outcomes: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab SAR236553 (REGN727)

This study is currently recruiting participants.
Verified April 2014 by Sanofi
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01663402
First received: August 8, 2012
Last updated: April 16, 2014
Last verified: April 2014
  Purpose

Primary Objective:

To compare the effect of alirocumab with placebo on the occurrence of cardiovascular events (composite endpoint of coronary heart disease (CHD) death, non-fatal myocardial infarction (MI), fatal and non-fatal ischemic stroke, unstable angina requiring hospitalization) in patients who have experienced an acute coronary syndrome (ACS) event 4 to 52 weeks prior to randomization and are 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, all cause mortality).
  • To evaluate the safety and tolerability of alirocumab.
  • To evaluate the effect of alirocumab on lipid parameters.

Condition Intervention Phase
Acute Coronary Syndrome
Drug: alirocumab SAR236553 (REGN727)
Other: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Time from randomization to first occurrence of one of the following clinical events: CHD death, any non-fatal MI, fatal and non-fatal ischemic stroke, unstable angina requiring hospitalization [ Time Frame: Up to Month 64 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to the first occurrence of any CHD event, major CHD event, any CV event, composite of all cause mortality/non-fatal MI/non-fatal ischemic stroke, all cause mortality [ Time Frame: Up to Month 64 ] [ Designated as safety issue: No ]
  • Change from baseline in blood lipids and lipoprotein levels [ Time Frame: Up to Month 64 ] [ Designated as safety issue: No ]

Estimated Enrollment: 18000
Study Start Date: October 2012
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Alirocumab SAR236553 (REGN727)

Injection through subcutaneous (SC) administration

Alirocumab is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9)

Drug: alirocumab SAR236553 (REGN727)
Pharmaceutical form: solution for injection Route of administration: subcutaneous
Placebo Comparator: Placebo
Injection through subcutaneous (SC) administration
Other: placebo
Pharmaceutical form: solution for injection Route of administration: subcutaneous

Detailed Description:

The maximum study duration will be 70 months, including up to a 4-month run-in period, 64 months randomized treatment period, and 2-month follow-up period.

Number of patients aged from 18 to 64 years and >=65 years old are based on the number of randomized patients (18000 patients).

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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) with evidence-based medical and dietary management of dyslipidemia.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01663402

Contacts
Contact: For site information, send an email with site number to Contact-Us@sanofi.com

  Show 959 Study Locations
Sponsors and Collaborators
Sanofi
Regeneron Pharmaceuticals
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01663402     History of Changes
Other Study ID Numbers: EFC11570, 2011-005698-21, U1111-1127-4323
Study First Received: August 8, 2012
Last Updated: April 16, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014