Ignite Creation Date:
2024-05-06 @ 12:48 AM
Last Modification Date:
2024-10-26 @ 10:55 AM
Study NCT ID:
NCT01663402
Status:
COMPLETED
Last Update Posted:
2019-03-18
First Post:
2012-08-08
Brief Title:
ODYSSEY Outcomes Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Parallel-Group Study to Evaluate the Effect of Alirocumab SAR236553REGN727 on the Occurrence of Cardiovascular Events in Patients Who Have Recently Experienced an Acute Coronary Syndrome
Status:
COMPLETED
Status Verified Date:
2019-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Primary Objective
To compare the effect of alirocumab with placebo on the occurrence of cardiovascular CV events composite endpoint of coronary heart disease CHD death non-fatal myocardial infarction MI fatal and non-fatal ischemic stroke unstable angina UA requiring hospitalization in participants who experienced an acute coronary syndrome ACS event 4 to 52 weeks prior to randomization and were 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 mortalitynon-fatal MInon-fatal ischemic stroke CHD deaths CV deaths all cause mortality
To evaluate the safety and tolerability of alirocumab
To evaluate the effect of alirocumab on lipid parameters
To compare the effect of alirocumab with placebo on the occurrence of cardiovascular CV events composite endpoint of coronary heart disease CHD death non-fatal myocardial infarction MI fatal and non-fatal ischemic stroke unstable angina UA requiring hospitalization in participants who experienced an acute coronary syndrome ACS event 4 to 52 weeks prior to randomization and were 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 mortalitynon-fatal MInon-fatal ischemic stroke CHD deaths CV deaths all cause mortality
To evaluate the safety and tolerability of alirocumab
To evaluate the effect of alirocumab on lipid parameters
Detailed Description:
18924 number of participants aged 40 years old were randomized in the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U1111-1127-4323 | OTHER | UTN | None |
| 2011-005698-21 | EUDRACT_NUMBER | None | None |