Published Online
on April 3, 2008

A more recent version of this article appeared on June 1, 2008

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Submitted on September 24, 2007
Accepted on October 19, 2007

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

Yukito Shinohara MD^*; Katsuya Nishimaru MD; Tohru Sawada MD; Akiro Terashi MD; Shunnosuke Handa MD; Shunsaku Hirai MD; Kunihiko Hayashi PhD; Hideo Tohgi MD; Yasuo Fukuuchi MD; Shinichiro Uchiyama MD; Takenori Yamaguchi MD; Shotai Kobayashi MD; Kazuoki Kondo MD; Eiichi Otomo MD; Fumio Gotoh MD; for the S-ACCESS Study Group

From the Department of Neurology (Y.S.), Federation of National Public Service Personnel Mutual Aid Associations, Tachikawa Hospital, Tokyo, Japan; Department of Neurology (K.N.), Fukuoka University, Japan; Department of Rehabilitation (T.S.), Aino Hospital, Osaka, Japan; Department of Internal Medicine (A.T.), Nippon Medical School, Tokyo, Japan; Department of Cardiology (S. Handa), Tokai University, Tokyo Hospital, Japan; Department of Neurology (S. Hirai), Gunma University, Japan; Department of Basic Allied Medicine, School of Health Sciences (K.H.), Gunma University, Japan; Department of Neurology (H.T.), Iwate Medical University, Japan; Department of Neurology (Y.F.), Ashikaga Red Cross Hospital, Tochigi, Japan; Department of Neurology (S.U.), Tokyo Women's Medical University School of Medicine, Japan; National Cardiovascular Center (T.Y.), Osaka, Japan; Department of Internal Medicine (S.K.), Shimane University Hospital, Japan; Mitsubishi Tanabe Pharma Corp (K.K.), Tokyo, Japan; Department of Internal Medicine (E.O.), Yokufukai Geriatric Hospital, Tokyo, Japan; and Department of Neurology (F.G.), Keio University, Tokyo, Japan.

^* To whom correspondence should be addressed. E-mail: yshinoha{at}tachikawa-hosp.gr.jp.

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<0.01).

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.

Key words: cerebrovascular diseases/stroke • clinical studies • secondary prevention • antiplatelet agents

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