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Effect of clopidogrel added to aspirin in patients with atrial fibrillation.

Publication ,  Journal Article
ACTIVE Investigators, ; Connolly, SJ; Pogue, J; Hart, RG; Hohnloser, SH; Pfeffer, M; Chrolavicius, S; Yusuf, S
Published in: N Engl J Med
May 14, 2009

BACKGROUND: Vitamin K antagonists reduce the risk of stroke in patients with atrial fibrillation but are considered unsuitable in many patients, who usually receive aspirin instead. We investigated the hypothesis that the addition of clopidogrel to aspirin would reduce the risk of vascular events in patients with atrial fibrillation. METHODS: A total of 7554 patients with atrial fibrillation who had an increased risk of stroke and for whom vitamin K-antagonist therapy was unsuitable were randomly assigned to receive clopidogrel (75 mg) or placebo, once daily, in addition to aspirin. The primary outcome was the composite of stroke, myocardial infarction, non-central nervous system systemic embolism, or death from vascular causes. RESULTS: At a median of 3.6 years of follow-up, major vascular events had occurred in 832 patients receiving clopidogrel (6.8% per year) and in 924 patients receiving placebo (7.6% per year) (relative risk with clopidogrel, 0.89; 95% confidence interval [CI], 0.81 to 0.98; P=0.01). The difference was primarily due to a reduction in the rate of stroke with clopidogrel. Stroke occurred in 296 patients receiving clopidogrel (2.4% per year) and 408 patients receiving placebo (3.3% per year) (relative risk, 0.72; 95% CI, 0.62 to 0.83; P<0.001). Myocardial infarction occurred in 90 patients receiving clopidogrel (0.7% per year) and in 115 receiving placebo (0.9% per year) (relative risk, 0.78; 95% CI, 0.59 to 1.03; P=0.08). Major bleeding occurred in 251 patients receiving clopidogrel (2.0% per year) and in 162 patients receiving placebo (1.3% per year) (relative risk, 1.57; 95% CI, 1.29 to 1.92; P<0.001). CONCLUSIONS: In patients with atrial fibrillation for whom vitamin K-antagonist therapy was unsuitable, the addition of clopidogrel to aspirin reduced the risk of major vascular events, especially stroke, and increased the risk of major hemorrhage. (ClinicalTrials.gov number, NCT00249873.)

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Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

May 14, 2009

Volume

360

Issue

20

Start / End Page

2066 / 2078

Location

United States

Related Subject Headings

  • Vitamin K
  • Vascular Diseases
  • Ticlopidine
  • Stroke
  • Risk
  • Platelet Aggregation Inhibitors
  • Myocardial Infarction
  • Middle Aged
  • Male
  • Incidence
 

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ACTIVE Investigators, ., Connolly, S. J., Pogue, J., Hart, R. G., Hohnloser, S. H., Pfeffer, M., … Yusuf, S. (2009). Effect of clopidogrel added to aspirin in patients with atrial fibrillation. N Engl J Med, 360(20), 2066–2078. https://doi.org/10.1056/NEJMoa0901301
ACTIVE Investigators, Salim, Stuart J. Connolly, Janice Pogue, Robert G. Hart, Stefan H. Hohnloser, Marc Pfeffer, Susan Chrolavicius, and Salim Yusuf. “Effect of clopidogrel added to aspirin in patients with atrial fibrillation.N Engl J Med 360, no. 20 (May 14, 2009): 2066–78. https://doi.org/10.1056/NEJMoa0901301.
ACTIVE Investigators, Connolly SJ, Pogue J, Hart RG, Hohnloser SH, Pfeffer M, et al. Effect of clopidogrel added to aspirin in patients with atrial fibrillation. N Engl J Med. 2009 May 14;360(20):2066–78.
ACTIVE Investigators, Salim, et al. “Effect of clopidogrel added to aspirin in patients with atrial fibrillation.N Engl J Med, vol. 360, no. 20, May 2009, pp. 2066–78. Pubmed, doi:10.1056/NEJMoa0901301.
ACTIVE Investigators, Connolly SJ, Pogue J, Hart RG, Hohnloser SH, Pfeffer M, Chrolavicius S, Yusuf S. Effect of clopidogrel added to aspirin in patients with atrial fibrillation. N Engl J Med. 2009 May 14;360(20):2066–2078.

Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

May 14, 2009

Volume

360

Issue

20

Start / End Page

2066 / 2078

Location

United States

Related Subject Headings

  • Vitamin K
  • Vascular Diseases
  • Ticlopidine
  • Stroke
  • Risk
  • Platelet Aggregation Inhibitors
  • Myocardial Infarction
  • Middle Aged
  • Male
  • Incidence