Forskning ved Københavns Universitet - Københavns Universitet


Aspirin and extended-release dipyridamole versus clopidogrel for recurrent stroke

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningfagfællebedømt

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

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. ( number, NCT00153062.)

TidsskriftNew England Journal of Medicine
Udgave nummer12
Sider (fra-til)1238-51
Antal sider14
StatusUdgivet - 18 sep. 2008

ID: 128985255