Conditions: Atrial Fibrillation Cardiovascular Disease
Keywords: Atrial fibrillation Cardiovascular disease angiotensin II blocker
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 9016
Healthy volunteers: no

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.

Arms:
arm 1: 150 mg for 2 weeks, then up-titrated to 300 mg up to final follow-up visit arm 2: Matching placebo up to final follow-up visit

Interventions: intervention 1: Irbesartan intervention 2: placebo
Intervention descriptions: intervention 1: oral administration (tablets) once daily intervention 2: oral administration (tablets) once daily

Protocol document: