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

Study Description

Brief Summary

Detailed Description

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 Date	August 08, 2012
Last Update Posted Date	February 13, 2018
Actual Start Date	October 01, 2012
Actual Completion Date	January 23, 2018
Actual Primary Completion Date	January 23, 2018
Results First Submitted Date	N/A
Received Results Disposit Date	N/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

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

Study Design

Brief Title	ODYSSEY Outcomes: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab
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
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 Type	Interventional
Study Phase	Phase 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 Method	N/A
Study Population	N/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 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

Recruitment Information

Recruitment Status:	Completed
Enrollment	18600
Completion Date	January 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.
Gender	All
Age	40 Years to N/A
Accepts Healthy Volunteers	No
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 Committee	Yes
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