Sarpogrelate-Aspirin Comparative Clinical Study for Efficacy and Safety in Secondary Prevention of Cerebral Infarction (S-ACCESS) : A Randomized, Double-Blind, Aspirin-Controlled Trial

• Published in: Stroke (1970) 2008-06, Vol.39 (6), p.1827-1833
• Main Authors: SHINOHARA, Yukito, NISHIMARU, Katsuya, YAMAGUCHI, Takenori, KOBAYASHI, Shotai, KONDO, Kazuoki, OTOMO, Eiichi, GOTOH, Fumio, SAWADA, Tohru, TERASHI, Akiro, HANDA, Shunnosuke, HIRAI, Shunsaku, HAYASHI, Kunihiko, TOHGI, Hideo, FUKUUCHI, Yasuo, UCHIYAMA, Shinichiro
• Format: Article
• Language: English
• Subjects: Aged; Aspirin - administration & dosage; Aspirin - adverse effects; Biological and medical sciences; Cardiovascular system; Cerebral Hemorrhage - chemically induced; Cerebral Hemorrhage - epidemiology; Cerebral Infarction - drug therapy; Cerebral Infarction - prevention & control; Double-Blind Method; Female; Humans; Incidence; Male; Medical sciences; Middle Aged; Neurology; Pharmacology. Drug treatments; Platelet Aggregation Inhibitors - administration & dosage; Platelet Aggregation Inhibitors - adverse effects; Receptors, Serotonin - drug effects; Receptors, Serotonin - metabolism; Secondary Prevention; Serotonin Antagonists - administration & dosage; Serotonin Antagonists - adverse effects; Succinates - administration & dosage; Succinates - adverse effects; Treatment Outcome; Vascular diseases and vascular malformations of the nervous system; Vasodilator agents. Cerebral vasodilators
• ISSN: 0039-2499; 1524-4628
• DOI: 10.1161/STROKEAHA.107.505131

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. 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. 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