Aspirin and Extended-Release Dipyridamole versus Clopidogrel for Recurrent Stroke Academic Article uri icon

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abstract

  • BACKGROUND: Recurrent stroke is a frequent, disabling event after ischemic stroke. This study compared the efficacy and safety of two antiplatelet regimens--aspirin plus extended-release dipyridamole (ASA-ERDP) versus clopidogrel. METHODS: In this double-blind, 2-by-2 factorial trial, we randomly assigned patients to receive 25 mg of aspirin plus 200 mg of extended-release dipyridamole twice daily or to receive 75 mg of clopidogrel daily. The primary outcome was first recurrence of stroke. The secondary outcome was a composite of stroke, myocardial infarction, or death from vascular causes. Sequential statistical testing of noninferiority (margin of 1.075), followed by superiority testing, was planned. RESULTS: A total of 20,332 patients were followed for a mean of 2.5 years. Recurrent stroke occurred in 916 patients (9.0%) receiving ASA-ERDP and in 898 patients (8.8%) receiving clopidogrel (hazard ratio, 1.01; 95% confidence interval [CI], 0.92 to 1.11). The secondary outcome occurred in 1333 patients (13.1%) in each group (hazard ratio for ASA-ERDP, 0.99; 95% CI, 0.92 to 1.07). There were more major hemorrhagic events among ASA-ERDP recipients (419 [4.1%]) than among clopidogrel recipients (365 [3.6%]) (hazard ratio, 1.15; 95% CI, 1.00 to 1.32), including intracranial hemorrhage (hazard ratio, 1.42; 95% CI, 1.11 to 1.83). The net risk of recurrent stroke or major hemorrhagic event was similar in the two groups (1194 ASA-ERDP recipients [11.7%], vs. 1156 clopidogrel recipients [11.4%]; hazard ratio, 1.03; 95% CI, 0.95 to 1.11). CONCLUSIONS: The trial did not meet the predefined criteria for noninferiority but showed similar rates of recurrent stroke with ASA-ERDP and with clopidogrel. There is no evidence that either of the two treatments was superior to the other in the prevention of recurrent stroke. (ClinicalTrials.gov number, NCT00153062.)

authors

  • Sacco, Ralph L
  • Diener, Hans-Christoph
  • Yusuf, Salim
  • Cotton, Daniel
  • Ôunpuu, Stephanie
  • Lawton, William A
  • Palesch, Yuko
  • Martin, Reneé H
  • Albers, Gregory W
  • Bath, Philip
  • Bornstein, Natan
  • Chan, Bernard PL
  • Chen, Sien-Tsong
  • Cunha, Luis
  • Dahlöf, Björn
  • De Keyser, Jacques
  • Donnan, Geoffrey A
  • Estol, Conrado
  • Gorelick, Philip
  • Gu, Vivian
  • Hermansson, Karin
  • Hilbrich, Lutz
  • Kaste, Markku
  • Lu, Chuanzhen
  • Machnig, Thomas
  • Pais, Prem
  • Roberts, Robin
  • Skvortsova, Veronika
  • Teal, Philip
  • Toni, Danilo
  • VanderMaelen, Cam
  • Voigt, Thor
  • Weber, Michael
  • Yoon, Byung-Woo

publication date

  • September 18, 2008

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