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

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) Note: 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

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clinical trial

References

  1. ClinicalTrials.gov http://clinicaltrials.gov/show/NCT00243178
  2. Connolly SJ et al for the ACTIVE Investigators Effect of Clopidogrel Added to Aspirin in Patients with Atrial Fibrillation N Engl J Med. 2009 Apr 3. [Epub ahead of print] PMID: 19336502 www.nejm.org March 31, 2009 (10.1056/NEJMoa0901301) http://content.nejm.org/cgi/content/full/NEJMoa0901301