JASAP: Japanese Aggrenox Stroke Prevention vs. Aspirin Programme

Phase 3 Completed 1295 enrolled Boehringer Ingelheim

Parallel-groupPrevention

Summary

Phase III study to compare the preventive effect of recurrent brain infarction and safety of Aggrenox (combination drug containing sustained-release dipyridamole 200 mg/acetylsalicylic acid 25 mg) twice daily vs. acetylsalicylic acid 81 mg once daily

Timeline

Start: 2006-04
Primary completion: 2009-03
Completion: —

Outcome

Missed primary endpoint

registry p = 0.097; Cox Proportional Hazard 1.47 (95% CI 0.93 to 2.31) NCT00311402 ↗

paper Noninferiority of ER-DP plus ASA versus ASA could not be shown. PMID 21502757 ↗

Publications

Uchiyama S, Ikeda Y, Urano Y, Horie Y, Yamaguchi T. The Japanese aggrenox (extended-release dipyridamole plus aspirin) stroke prevention versus aspirin programme (JASAP) study: a randomized, double-blind, controlled trial. Cerebrovasc Dis. 2011;31(6):601-13. doi: 10.1159/000327035. Epub 2011 Apr 19.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Aggrenox	Unknown	50 mg	—
Subject	Aggrenox	Unknown	200 mg	—