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

This study is currently recruiting participants.
Verified May 2013 by Sanofi
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01663402
First received: August 8, 2012
Last updated: May 15, 2013
Last verified: May 2013
History of Changes
  Purpose

Primary Objective:

To compare the effect of SAR236553 (REGN727) 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 16 weeks prior to randomization and are treated with evidence-based medical and dietary management of dyslipidemia.

Secondary Objectives:

To evaluate the effect of SAR236553 (REGN727) 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 SAR236553 (REGN727). To evaluate the effect of SAR236553 (REGN727) on lipid parameters.


Condition Intervention Phase
Acute Coronary Syndrome
 Drug: 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 SAR236553/REGN727 on the Occurrence of Cardiovascular Events in Patients Who Have Recently Experienced an Acute Coronary Syndrome

Resource links provided by NLM:

MedlinePlus related topics: Angina
U.S. FDA Resources

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 ]
  • Number of patients with adverse events [ Time Frame: Up to Month 64 ] [ Designated as safety issue: No ]

Estimated Enrollment: 18000
Study Start Date: October 2012
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SAR236553 (REGN727)
Injection through subcutaneous (SC) administration - Type: Experimental
 Drug: SAR236553 (REGN727)

SAR236553 (REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9)

Pharmaceutical form:solution for injection Route of administration: subcutaneous
Placebo
Injection through subcutaneous (SC) administration - Type: Placebo Comparator
 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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

- Recently hospitalized for ACS.

Exclusion criteria:

  • Age < 40 years.
  • ACS event occurring more than 16 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 163 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: May 15, 2013
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 May 19, 2013