What is the clinical evidence from this study?

Study design: RCT. Population: recent cerebral infarction (n=1510). Intervention: Sarpogrelate vs. Aspirin (81 mg/d). Primary outcome: recurrence of cerebral infarction (HR 1.25, 95% CI 0.89 to 1.77, p=0.19).

April 4, 2008

Sarpogrelate-Aspirin Comparative Clinical Study for Efficacy and Safety in Secondary Prevention of Cerebral Infarction (S-ACCESS)

Key Result

Sarpogrelate was not noninferior to aspirin for prevention of recurrence of cerebral infarction (HR 1.25; 95% CI 0.89-1.77; P=0.19).

Study Design

Type

RCT (n=1,510)

Structured PICO

Does sarpogrelate prevent recurrence of cerebral infarction compared to aspirin in Japanese patients with recent cerebral infarction?

Population

1,510 Japanese patients with recent cerebral infarction (1 week to 6 months after onset), followed for a mean of 1.59 years.

Intervention

Sarpogrelate 100 mg TID

Comparator

Aspirin 81 mg/d

Outcome

Recurrence of cerebral infarctionhard clinical

In Japanese patients with recent cerebral infarction, sarpogrelate failed to demonstrate noninferiority to aspirin for preventing recurrent cerebral infarction, though it was associated with fewer bleeding events.

Main Result

Hazard Ratio: 1.25 (95% CI 0.89–1.77)

Absolute Event Rate: 6.09% vs 4.86%

p-value: p=0.19

Abstract

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.