| Company Name | Daiichi Sankyo Taiwan Ltd. |
|---|---|
| Protocol Number | CS747S-B-A4003 |
| Title of Study | Phase IV, non-comparative, open label, multicenter, 28-week switching study of prasugrel maintenance dose from clopidogrel in patients with acute coronary syndrome (ACS) who underwent a percutaneous coronary intervention (PCI) in Taiwan |
| Primary Objective | To assess the antiplatelet effect of prasugrel on P2Y12 reactive unit (PRU) value assessed with VerifyNow® from baseline to the end of the 4-week MD treatment period, after switching from clopidogrel MD to prasugrel MD and To assess the safety of prasugrel on major bleeding events from baseline to the end of the 28-week MD treatment period, after switching from clopidogrel MD to prasugrel MD |
| Number of Sites | 10 |
| Period of Study | From：Sep 2018 to：Mar 2021 |
| Number of Patients | 200人 |
| IRB Approval Date | 21Jun2018 |
| Publication Plan / Date | July 25, 2020 (First Stage) |
