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
1
Department of neurology
2 Department of neurology
3 Boehringer Ingelheim GmbH
4 Population Health Research Institute
5 Boehringer Ingelheim Pharmaceuticals
6 Boehringer Ingelheim
7 Boehringer Ingelheim Ltd
8 Department of biostatistics, Bioinformatics and Epidemiology
9 Neurology and Neurological Sciences
10 Stroke Trials Unit
11 Neurology Department
12 Division of Neurology, Department of Medicine
13 Department of Neurology
14 Neurology department
15 Institute of Medicine
16 Department of neurology
17 National Stroke Research Institute
18 Neurological Center for Treatment and Research
19 Department of Neurology and Rehabilitation
20 Boehringer Ingelheim Shanghai Pharmaceuticals Co Ltd
21 Boehringer Ingelheim AB
22 Department of Neurology
23 Neurology Department
24 Saint John's Medical College
25 Clinical Trials Methodoloy Group
26 Neurology & Neurosurgery Clinic
27 Department of Medicine, Neurology, Faculty of Medicine
28 Department of Neurological Sciences
29 Cardiology Department
30 Department of Neurology
31 Service de Neurologie [CHU Limoges]
32 NETEC - Neuroépidémiologie Tropicale et Comparée
2 Department of neurology
3 Boehringer Ingelheim GmbH
4 Population Health Research Institute
5 Boehringer Ingelheim Pharmaceuticals
6 Boehringer Ingelheim
7 Boehringer Ingelheim Ltd
8 Department of biostatistics, Bioinformatics and Epidemiology
9 Neurology and Neurological Sciences
10 Stroke Trials Unit
11 Neurology Department
12 Division of Neurology, Department of Medicine
13 Department of Neurology
14 Neurology department
15 Institute of Medicine
16 Department of neurology
17 National Stroke Research Institute
18 Neurological Center for Treatment and Research
19 Department of Neurology and Rehabilitation
20 Boehringer Ingelheim Shanghai Pharmaceuticals Co Ltd
21 Boehringer Ingelheim AB
22 Department of Neurology
23 Neurology Department
24 Saint John's Medical College
25 Clinical Trials Methodoloy Group
26 Neurology & Neurosurgery Clinic
27 Department of Medicine, Neurology, Faculty of Medicine
28 Department of Neurological Sciences
29 Cardiology Department
30 Department of Neurology
31 Service de Neurologie [CHU Limoges]
32 NETEC - Neuroépidémiologie Tropicale et Comparée
Ralph L Sacco
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- PersonId : 911153
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Hans-Christoph Diener
- Fonction : Auteur
- PersonId : 911077
Michael Weber
- Fonction : Auteur
- PersonId : 752076
- IdHAL : michael-weber
- ORCID : 0000-0003-3484-5821
- IdRef : 078857430
Francisco Macian-Montoro
- Fonction : Auteur
- PersonId : 856860
Résumé
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.)