completed

The objective of the ACTIVE I study was to determine the efficacy (superiority) of Irbesartan compared to placebo to 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.

Composite outcome:

Stroke, myocardial infarction, vascular death, or hospitalization for heart failure.

Study Type

Interventional - Drug

Study Design

Double-blind, placebo-controlled, factorial design superiority RCT

NO. of Countries

33

NO. of Sites

633

NO. of Participants

9015

Study Period

2003 - 2009

Sponsor

Sanofi

Bristol-Myers Squibb

Sanofi

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