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SHR Neuro Cancer Cardio Lipid Metab Microb
Sacco, RL; Diener, HC; Yusuf, S; Cotton, D; Ounpuu, S; Lawton, WA; Palesch, Y; Martin, RH; Albers, GW; Bath, P; Bornstein, N; Chan, BP; Chen, ST; Cunha, L; Dahlöf, B; De Keyser, J; Donnan, GA; Estol, C; Gorelick, P; Gu, V; Hermansson, K; Hilbrich, L; Kaste, M; Lu, C; Machnig, T; Pais, P; Roberts, R; Skvortsova, V; Teal, P; Toni, D; Vandermaelen, C; Voigt, T; Weber, M; Yoon, BW; PRoFESS Study Group.
Aspirin and extended-release dipyridamole versus clopidogrel for recurrent stroke.
N Engl J Med. 2008; 359(12):1238-1251
Doi: 10.1056/NEJMoa0805002
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- Horner Susanna
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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.)
- Find related publications in this database (using NLM MeSH Indexing)
- Aged -
- Angiotensin-Converting Enzyme Inhibitors - therapeutic use
- Aspirin - administration and dosage
- Benzimidazoles - therapeutic use
- Benzoates - therapeutic use
- Brain Ischemia - epidemiology
- Delayed-Action Preparations - epidemiology
- Dipyridamole - adverse effects
- Double-Blind Method - adverse effects
- Drug Therapy, Combination - adverse effects
- Factor Analysis, Statistical - adverse effects
- Female - adverse effects
- Hemorrhage - chemically induced
- Humans - chemically induced
- Kaplan-Meiers Estimate - chemically induced
- Male - chemically induced
- Middle Aged - chemically induced
- Myocardial Infarction - epidemiology
- Platelet Aggregation Inhibitors - administration and dosage
- Proportional Hazards Models - administration and dosage
- Recurrence - prevention and control
- Risk - prevention and control
- Stroke - drug therapy
- Ticlopidine - adverse effects
- Vascular Diseases - mortality