Atrial Fibrillation Clopidogrel Trial With Irbesartan for Prevention of Vascular Events (ACTIVE A,W,I) trial

Introduction

ACTIVE W: eligible for warfarin

ACTIVE A: not eligible for warfarin

ACTIVE I: randomization to either irbesartan or placebo

Industry-sponsored: Sanofi-Aventis & Bristol-Myers Squibb

Active A:

Study characteristics:

• 7500 adults with atrial fibrillation & cardiovascular risk factors
• participants not candidates for warfarin

Study design:

• randomized to receive daily clopidogrel 75 mg QD or placebo
• all patients received aspirin 75-100 mg QD
• median 3.6-year follow-up

Results:

• major vascular events significantly lower with clopidogrel than placebo (6.8% vs 7.6% per year)
• major bleeding occurred more often with clopidogrel (2.0% vs. 1.3% per year)

Notes

Although cardiologist commentary suggests marginal benefit in stroke risk will outweigh the relatively larger compensatory risk for gastrointestinal bleed & tip the balance toward clopidogrel, it would be interesting to hear a gastroenterology perspective

More general terms

• clinical trial