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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01663402
First Posted: August 13, 2012
Last Update Posted: March 3, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi
August 8, 2012
August 13, 2012
March 3, 2017
October 2012
December 2017   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01663402 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Change from baseline in blood lipids and lipoprotein levels [ Time Frame: Up to Month 64 ]
  • 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 ]
  • Change from baseline in blood lipids and lipoprotein levels [ Time Frame: Up to Month 64 ]
  • Number of patients with adverse events [ Time Frame: Up to Month 64 ]
Not Provided
Not Provided
 
ODYSSEY Outcomes: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab
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

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.

The maximum study duration will be 64 months, including up to a 4-month run-in period, 60 months randomized treatment period.

Number of patients aged from 18 to 64 years and >= 65 years old are based on the number of randomized patients (18600 patients).

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Acute Coronary Syndrome
  • Drug: alirocumab

    Pharmaceutical form: solution for injection

    Route of administration: subcutaneous

    Other Names:
    • SAR236553
    • REGN727
  • Drug: Placebo

    Pharmaceutical form: solution for injection

    Route of administration: subcutaneous

  • Experimental: Alirocumab

    Injection through subcutaneous (SC) administration

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

    Intervention: Drug: alirocumab
  • Placebo Comparator: Placebo
    Injection through subcutaneous (SC) administration
    Intervention: Drug: Placebo
Schwartz GG, Bessac L, Berdan LG, Bhatt DL, Bittner V, Diaz R, Goodman SG, Hanotin C, Harrington RA, Jukema JW, Mahaffey KW, Moryusef A, Pordy R, Roe MT, Rorick T, Sasiela WJ, Shirodaria C, Szarek M, Tamby JF, Tricoci P, White H, Zeiher A, Steg PG. Effect of alirocumab, a monoclonal antibody to PCSK9, on long-term cardiovascular outcomes following acute coronary syndromes: rationale and design of the ODYSSEY outcomes trial. Am Heart J. 2014 Nov;168(5):682-9. doi: 10.1016/j.ahj.2014.07.028. Epub 2014 Aug 7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
18600
December 2017
December 2017   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
40 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Australia,   Austria,   Belgium,   Bosnia and Herzegovina,   Brazil,   Bulgaria,   Canada,   Chile,   China,   Colombia,   Croatia,   Czech Republic,   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
 
 
NCT01663402
EFC11570
2011-005698-21 ( EudraCT Number )
U1111-1127-4323 ( Other Identifier: UTN )
Yes
Not Provided
Not Provided
Sanofi
Sanofi
Regeneron Pharmaceuticals
Study Director: Clinical Sciences & Operations Sanofi
Sanofi
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP
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