Ignite Creation Date:
2025-12-24 @ 1:56 PM
Ignite Modification Date:
2025-12-31 @ 7:13 AM
Study NCT ID:
NCT00249795
Status:
COMPLETED
Last Update Posted:
2010-10-15
First Post:
2005-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Atrial Fibrillation Clopidogrel Trial With Irbesartan for Prevention of Vascular Events (ACTIVE I)
Sponsor:
Sanofi
Organization:
Study Overview
Official Title:
A Parallel Randomized Controlled Evaluation of Clopidogrel Plus Aspirin, With Factorial Evaluation of Irbesartan, for the Prevention of Vascular Events, in Patients With Atrial Fibrillation
Status:
COMPLETED
Status Verified Date:
2010-09
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:
ACTIVE I
Brief Summary:
The purpose of this study was to determine if Irbesartan compared to Placebo would reduce the risk of vascular events such as heart attack, stroke, non-cerebral thromboembolic event and death in patients with Atrial Fibrillation (AF) and with at least one major risk of vascular events.
Detailed Description:
ACTIVE I was one of the 3 separate but related trials of the ACTIVE program conducted in AF patients at risk of vascular events.
Patients were enrolled first into one of the 2 parallel trials of the ACTIVE program evaluating Clopidogrel:
* ACTIVE A comparing clopidogrel + acetylsalicylic acid (ASA) and ASA alone
* ACTIVE W comparing clopidogrel + ASA and oral anticoagulant (OAC).
Then those satisfying additional criteria related to blood pressure and angiotensin receptor blocking agents were re-randomized in the two ACTIVE I arms according to a separate randomization list.
Patients were enrolled first into one of the 2 parallel trials of the ACTIVE program evaluating Clopidogrel:
* ACTIVE A comparing clopidogrel + acetylsalicylic acid (ASA) and ASA alone
* ACTIVE W comparing clopidogrel + ASA and oral anticoagulant (OAC).
Then those satisfying additional criteria related to blood pressure and angiotensin receptor blocking agents were re-randomized in the two ACTIVE I arms according to a separate randomization list.
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| Clopidogrel (SR25990) | None | None | View |