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SLCTR Registration Number
SLCTR/2013/034
Date of Registration
The date of last modification
Mar 27, 2014
View original TRDS
Scientific Title of Trial
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
Public Title of Trial
Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With SAR236553 (REGN727)
Disease or Health Condition(s) Studied
Hypercholesterolemia, Acute Coronary Syndromes
Scientific Acronym
ODYSSEY OUTCOMES
Public Acronym
None
Brief title
None
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
EFC11570 (Internal Protocol Number)NCT01663402 (clinicaltrials.gov)
What is the research question being addressed?
What is the effectiveness of the lipid lowering agent SAR236553 compared to 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 intensive statin therapy
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Double blinded
Control
Placebo
Assignment
Parallel
Purpose
Treatment
Study Phase
Phase 3
Intervention(s) planned
Consenting patients will be randomized into two arms. The intervention arm will receive SAR236553 - 75mg/150mg as a subcutaneous injection every two weeks until a study end-point is reached. It is expected that that each patient will receive the allocated treatment for at least 24 months.
The cotrol arm will receive a standardized placebo as a subcutaneous injection every two weeks for (please give duration).
Standard therapy will be continued for both arms.
Inclusion criteria
Exclusion criteria
Laboratory findings measured during screening and before randomization visit: Positive test for hepatitis B surface antigen and/or hepatitis C antibody, Triglycerides (TG) > 400mg/dL (>4.52 mmol/L) (1 repeat lab allowed), Positive serum or urine pregnancy test in females of childbearing potential, eGFR <30 mL/min/1.73 m² according to 4-variable MDRD Study equation (calculated by central lab), ALT or AST >3 x ULN on most recent determination prior to randomization (1 repeat lab is allowed), CPK >3 x ULN on most recent determination prior to randomization (1 repeat lab is allowed).
Any clinically significant abnormality identified at the time of screening that in the judgment of the Investigator or any sub-Investigator would preclude safe completion of the study or constrain endpoints assessment such as major systemic diseases, patients with short life expectancy.
Patients considered by the Investigator or any sub-Investigator as inappropriate for this study for any reason, eg: •Those deemed unable to meet specific protocol requirements, such as scheduled visits. •Investigator or any sub-Investigator, pharmacist, study coordinator, other study staff or relative thereof directly involved in the conduct of the protocol, etc. •Presence of any other conditions (eg, geographic, social….) actual or anticipated, that the Investigator feels would restrict or limit the patient’s participation for the duration of the study
Primary outcome(s)
1.
|
[ From randomization up to 64months ] |
2.
Any non-fatal MI |
[ From randomization up to 64months ] |
3.
Fatal and non-fatal ischemic stroke |
[ From randomization up to 64months ] |
4.
Unstable angina requiring hospitalization |
[ From randomization up to 64months ] |
Secondary outcome(s)
1.
The first occurrence of 1. Any CHD event, 2. Major CHD event, 3. Any CV event, 4. Composite of all cause mortality/non-fatal MI/non-fatal ischemic stroke, 5. All cause mortality |
[ Every month up to completion 64 months post randomization.ar ] |
2.
The first occurrence of Major CHD event |
[ Every month up to completion 64 months post randomization ] |
3.
The first occurrence of Any CV event |
[ Every month up to completion 64 months post randomization ] |
4.
Composite of all cause mortality/non-fatal MI/non-fatal ischemic stroke |
[ Every month up to completion 64 months post randomization ] |
5.
All cause mortality |
[ Every month up to completion 64 months post randomization ] |
Target number/sample size
250
Countries of recruitment
Argentina, Australia, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Hong Kong, Hungary, India, Israel, Italy, Latvia, Lithuania, Malaysia, Mexico, Netherlands, Norway, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Serbia, Singapore, Slovakia, South Africa, Spain, Sri Lanka, Switzerland, Taiwan, Province of China, Thailand, Turkey, Ukraine, United Kingdom, United States
Anticipated start date
2013-11-18
Anticipated end date
2018-03-15
Date of first enrollment
Date of study completion
Recruitment status
Recruiting
Funding source
Sanofi-Aventis
Regulatory approvals
Status
Date of Approval
Approval number
Details of Ethics Review Committee
Name: | |
Institutional Address: | |
Telephone: | |
Email: |
Primary study sponsor/organization
Sanofi-Aventis
I, avenue Pierre Brossolette, 91380 Chilly-Mazarin, France
+33 1 60 49 77 77
+33 1 60 49 77 77
www.sanofi.com
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results