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Aspirin and extended-release dipyridamole versus clopidogrel for recurrent stroke.

Ralph L Sacco 1, * Hans-Christoph Diener 2, 3 Salim Yusuf 4 Daniel Cotton 5 Stephanie Ounpuu 6 William A Lawton 7 Yuko Palesch 8 Reneé H Martin 8 Gregory W Albers 9 Philip Bath 10 Natan Bornstein 11 Bernard P L Chan 12 Sien-Tsong Chen 13 Luis Cunha 14 Björn Dahlöf 15 Jacques de Keyser 16 Geoffrey A Donnan 17 Conrado Estol 18 Philip Gorelick 19 Vivian Gu 20 Karin Hermansson 21 Lutz Hilbrich 5 Markku Kaste 22 Chuanzhen Lu 23 Thomas Machnig 3 Prem Pais 24 Robin Roberts 25 Veronika Skvortsova 26 Philip Teal 27 Danilo Toni 28 Cam Vandermaelen 5 Thor Voigt 5 Michael Weber 29 Byung-Woo Yoon 30 Francisco Macian-Montoro 31, 32 Group Prevention Regimen For Effectively Avoiding Second Strokes (profess) Study
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.)
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https://hal-unilim.archives-ouvertes.fr/hal-00627279
Contributeur : Florent Lachal <>
Soumis le : mercredi 28 septembre 2011 - 11:43:52
Dernière modification le : mardi 2 juin 2020 - 19:30:02

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Ralph L Sacco, Hans-Christoph Diener, Salim Yusuf, Daniel Cotton, Stephanie Ounpuu, et al.. Aspirin and extended-release dipyridamole versus clopidogrel for recurrent stroke.. New England Journal of Medicine, Massachusetts Medical Society, 2008, 359 (12), pp.1238-51. ⟨10.1056/NEJMoa0805002⟩. ⟨hal-00627279⟩

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