Sarpogrelate-Aspirin Comparative Clinical Study for Efficacy and Safety in Secondary Prevention of Cerebral Infarction (S-ACCESS)
| Autor: | Yukito, Shinohara, Katsuya, Nishimaru, Tohru, Sawada, Akiro, Terashi, Shunnosuke, Handa, Shunsaku, Hirai, Kunihiko, Hayashi, Hideo, Tohgi, Yasuo, Fukuuchi, Shinichiro, Uchiyama, Takenori, Yamaguchi, Shotai, Kobayashi, Kazuoki, Kondo, Eiichi, Otomo, Fumio, Gotoh, R, Hamada |
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| Rok vydání: | 2008 |
| Předmět: |
Male
Acute coronary syndrome Sarpogrelate law.invention chemistry.chemical_compound Double-Blind Method Randomized controlled trial law Secondary Prevention medicine Humans Stroke Aged Cerebral Hemorrhage Advanced and Specialized Nursing Aspirin Vascular disease business.industry Cerebral infarction Incidence Succinates Cerebral Infarction Middle Aged medicine.disease Treatment Outcome chemistry Receptors Serotonin Anesthesia Platelet aggregation inhibitor Female Serotonin Antagonists Neurology (clinical) Cardiology and Cardiovascular Medicine business Platelet Aggregation Inhibitors medicine.drug |
| Zdroj: | Stroke. 39:1827-1833 |
| ISSN: | 1524-4628 0039-2499 |
| Popis: | Background and Purpose— The antiplatelet agent sarpogrelate is a selective inhibitor of 5-hydroxytryptamine receptors. The purpose of this study was to compare the efficacy and safety of sarpogrelate with those of aspirin in Japanese ischemic stroke patients. Methods— In total, 1510 patients with recent cerebral infarction (1 week to 6 months after onset) were randomly assigned to receive either sarpogrelate (100 mg TID) or aspirin (81 mg/d). Mean follow-up period was 1.59 years. The primary efficacy end point was recurrence of cerebral infarction. Clusters of serious vascular events (stroke, acute coronary syndrome, or vascular event–related death) were selected as secondary end points. The aim of the primary efficacy analysis was to demonstrate the noninferiority of sarpogrelate with respect to aspirin, with the criterion that the upper limit of the 95% CI of the hazard ratio (sarpogrelate vs aspirin) for recurrence of cerebral infarction should not exceed 1.33. Results— Cerebral infarction recurred in 72 patients (6.09%/y) in the sarpogrelate group and in 58 (4.86%/y) in the aspirin group (hazard ratio=1.25; 95% CI, 0.89 to 1.77; P =0.19). A serious vascular event occurred in 90 (7.61%/y) and in 85 (7.12%/y) patients, respectively (hazard ratio=1.07; 95% CI, 0.80 to 1.44; P =0.65). The overall incidences of bleeding events were 89 (11.9%) and 131 (17.3%), respectively ( P Conclusions— Sarpogrelate was not noninferior to aspirin for prevention of recurrence of cerebral infarction. Bleeding events were significantly fewer with sarpogrelate than aspirin. The effect of aspirin in Japanese patients was similar to that in Western studies. |
| Databáze: | OpenAIRE |
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