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

ID: NCT01663402
Status: Completed
Phase: Phase 3
Start Date: October 01, 2012
First Submitted: August 08, 2012
Last Updated: February 13, 2018
Results: N/A
Organization: Sanofi
Sponsors & Collaborators: Sanofi, Regeneron Pharmaceuticals
Location: Argentina, Australia, Austria, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, 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
Conditions: Acute Coronary Syndrome
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Study Description

Brief Summary

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.

Detailed Description

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).
Condition or disease Intervention/treatment Phase

Acute Coronary Syndrome

Drug: alirocumab
Other Names
SAR236553 REGN727
Drug: Placebo
Other Names
Phase 3

Tracking Information

First Submitted DateAugust 08, 2012
Last Update Posted DateFebruary 13, 2018
Actual Start DateOctober 01, 2012
Actual Completion DateJanuary 23, 2018
Actual Primary Completion DateJanuary 23, 2018
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current 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]

Original Primary Outcome Measures

Not Available

Current 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]

  • Change from baseline in blood lipids and lipoprotein levels [Time Frame: Up to Month 64]

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleODYSSEY Outcomes: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab
Official TitleA 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
Brief Summary

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.

Detailed Description

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).

Study TypeInterventional
Study PhasePhase 3
Estimated Enrollment
18600
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
Quadruple
Primary Purpose
Prevention
Conditions
Acute Coronary Syndrome
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
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

Other Names
Study Groups/Cohorts
Alirocumab
Injection through subcutaneous (SC) administration Alirocumab is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9)

Placebo
Injection through subcutaneous (SC) administration

Study Arms
Experimental Alirocumab
Injection through subcutaneous (SC) administration Alirocumab is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9)
Drug : alirocumab
Pharmaceutical form: solution for injection Route of administration: subcutaneous

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

Arm Intervention/Treatment
Experimental Alirocumab
Injection through subcutaneous (SC) administration Alirocumab is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9)
Drug : alirocumab
Placebo Comparator Placebo
Injection through subcutaneous (SC) administration
Drug : Placebo

Recruitment Information

Recruitment Status:Completed
Enrollment18600
Completion DateJanuary 23, 2018
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) 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.
GenderAll
Age40 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Not Available
Listed Location Countries
Argentina
Australia
Austria
Belgium
Bosnia and Herzegovina
Brazil
Bulgaria
Canada
Chile
China
Colombia
Croatia
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
Czech Republic

Administrative Information

NCT Number:NCT01663402
Other Study ID Numbers
EFC11570
2011-005698-21
U1111-1127-4323
Has Data Monitoring CommitteeYes
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
Sanofi
Collaborators
Regeneron Pharmaceuticals
Investigators
Study Director
Clinical Sciences & Operations
Sanofi