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

Phase 3 Completed 1510 enrolled Tanabe Pharma Corporation

RandomizedParallel-groupQuadruple-blindPrevention

Summary

Sarpogrelate (MCI-9042) is an antiplatelet drug that decreases 5-hydroxytryptamine (5-HT) levels in platelets via a blockade of 5-HT2 receptors; it has been used in atherosclerotic peripheral arterial disease. S-ACCESS was a randomized, double-blinded trial to compare the relative efficacy of sarpogrelate (100mg three times daily) and aspirin (81mg once daily) in 1510 patients with recent cerebral infarction. Patients were followed for 0.9 to 3.5 years. The primary endpoint was recurrence of cerebral infarction; relative safety was also assessed.

Timeline

Start: 2001-01
Primary completion: 2004-09
Completion: 2004-09

Outcome

Missed primary endpoint

paper Sarpogrelate was not noninferior to aspirin for prevention of recurrence of cerebral infarction. PMID 18388340 ↗

Publications

Results Shinohara Y, Nishimaru K, Sawada T, Terashi A, Handa S, Hirai S, Hayashi K, Tohgi H, Fukuuchi Y, Uchiyama S, Yamaguchi T, Kobayashi S, Kondo K, Otomo E, Gotoh F; S-ACCESS Study Group. Sarpogrelate-Aspirin Comparative Clinical Study for Efficacy and Safety in Secondary Prevention of Cerebral Infarction (S-ACCESS): A randomized, double-blind, aspirin-controlled trial. Stroke. 2008 Jun;39(6):1827-33. doi: 10.1161/STROKEAHA.107.505131. Epub 2008 Apr 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Aspirin	Small molecule	81 mg	—
Subject	Sarpogrelate	Small molecule	100 mg	—