期刊
NEW ENGLAND JOURNAL OF MEDICINE
卷 359, 期 12, 页码 1238-1251出版社
MASSACHUSETTS MEDICAL SOC
DOI: 10.1056/NEJMoa0805002
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资金
- Boehringer Ingelheim
- GlaxoSmithKline
- Sanofi-Aventis
- Abbott
- AstraZeneca
- Bayer Vital
- Bristol-Myers Squibb
- D-Pharm
- Fresenius
- Janssen Cilag
- Merck Sharp Dohme
- Novartis
- Novo Nordisk
- Paion
- Parke-Davis
- Pfizer
- Sankyo
- Servier
- Solvay
- Thrombogenics
- Wyeth
- Yamaguchi
- NMT Medical
- Parexel International
- Forest Research Institute
- Daiichi-Sankyo
- Bayer
- TAP Pharmaceutical Products
- Myriad
- Takeda
- Daiichi Sankyo
- Merck
- Brainsgate
- diaDexus
- Forest Laboratories
- Gilead
- Korea Health Promotion Institute [A060171, A080602] Funding Source: Korea Institute of Science & Technology Information (KISTI), National Science & Technology Information Service (NTIS)
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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