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Aspirin and extended-release dipyridamole versus clopidogrel for recurrent stroke

Cited 565 time in Web of Science Cited 704 time in Scopus
Authors
Sacco, Ralph L; Diener, Hans-Christoph; Yusuf, Salim; Cotton, Daniel; Ounpuu, Stephanie; Lawton, William A; Palesch, Yuko; Martin, Renee H; Albers, Gregory W; Bath, Philip; Bornstein, Natan; Chan, Bernard P L; Chen, Sien-Tsong; Cunha, Luis; Dahlof, Bjorn; 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
Issue Date
2008-08-30
Publisher
Massachusetts Medical Society
Citation
N Engl J Med. 2008;359(12):1238-1251
Keywords
AgedAngiotensin-Converting Enzyme Inhibitors/therapeutic useAspirin/*administration & dosage/adverse effectsBenzimidazoles/therapeutic useBenzoates/therapeutic useBrain Ischemia/epidemiology/prevention & controlDelayed-Action PreparationsDipyridamole/adverse effects/*therapeutic useDouble-Blind MethodDrug Therapy, CombinationFactor Analysis, StatisticalFemaleHemorrhage/chemically inducedHumansKaplan-Meiers EstimateMaleMiddle AgedMyocardial Infarction/epidemiologyPlatelet Aggregation Inhibitors/administration & dosage/adverse effects/*therapeutic useProportional Hazards ModelsRecurrence/prevention & controlRiskStroke/*drug therapy/epidemiology/prevention & controlTiclopidine/adverse effects/*analogs & derivatives/therapeutic useVascular Diseases/mortality
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.)
ISSN
1533-4406 (Electronic)
Language
English
URI
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Citation&list_uids=18753638

http://content.nejm.org/cgi/reprint/359/12/1238.pdf

http://hdl.handle.net/10371/68329
DOI
https://doi.org/10.1056/NEJMoa0805002
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College of Medicine/School of Medicine (의과대학/대학원)Dept. of Neurology (신경과학교실)Journal Papers (저널논문_신경과학교실)
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