Sarpogrelate-Aspirin Comparative Clinical Study for Efficacy and Safety in Secondary Prevention of Cerebral Infarction (S-ACCESS): A randomized, double-blind, aspirin-controlled trial.
OBJECTIVE
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.
Shinohara
Yukito
Y
Department of Neurology, Federation of National Public Service Personnel Mutual Aid Associations, Tachikawa Hospital, 4-2-22 Nishikicho, Tachikawa, Tokyo 190-8531, Japan. yshinoha@tachikawa-hosp.gr.jp
Nishimaru
Katsuya
K
Sawada
Tohru
T
Terashi
Akiro
A
Handa
Shunnosuke
S
Hirai
Shunsaku
S
Hayashi
Kunihiko
K
Tohgi
Hideo
H
Fukuuchi
Yasuo
Y
Uchiyama
Shinichiro
S
Yamaguchi
Takenori
T
Kobayashi
Shotai
S
Kondo
Kazuoki
K
Otomo
Eiichi
E
Gotoh
Fumio
F
D000368:Aged; D001241:Aspirin / Q000008:administration & dosage* / Q000009:adverse effects; D002543:Cerebral Hemorrhage / Q000139:chemically induced / Q000453:epidemiology; D002544:Cerebral Infarction / Q000188:drug therapy* / Q000517:prevention & control*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D011985:Receptors, Serotonin / Q000187:drug effects / Q000378:metabolism; D055502:Secondary Prevention; D012702:Serotonin Antagonists / Q000008:administration & dosage / Q000009:adverse effects; D013386:Succinates / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
D010975:Platelet Aggregation Inhibitors; D011985:Receptors, Serotonin; D012702:Serotonin Antagonists; D013386:Succinates; C064294:sarpogrelate; D001241:Aspirin