Atrial Fibrillation Clopidogrel Trial With Irbesartan for Prevention of Vascular Events (ACTIVE I)

Phase 3 Completed 9016 enrolled Sanofi Bristol-Myers Squibb · collab

RandomizedParallel-groupTriple-blindPrevention

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.

Timeline

Start: 2003-06
Primary completion: 2009-08
Completion: 2009-08

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Irbesartan vs Placebo; p = 0.8570; Hazard Ratio (HR) 0.992 (95% CI 0.907 to 1.085); NCT00249795 ↗

registry analysis (superiority or other test); Irbesartan vs Placebo; p = 0.1200; Hazard Ratio (HR) 0.940 (95% CI 0.869 to 1.016); NCT00249795 ↗

Publications

ACTIVE I Investigators; Yusuf S, Healey JS, Pogue J, Chrolavicius S, Flather M, Hart RG, Hohnloser SH, Joyner CD, Pfeffer MA, Connolly SJ. Irbesartan in patients with atrial fibrillation. N Engl J Med. 2011 Mar 10;364(10):928-38. doi: 10.1056/NEJMoa1008816.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Irbesartan	Small molecule	300 mg	Oral