PMS Registry
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:Sep 2019
Number of Patients
200人
IRB Approval Date
21Jun2018
Publication Plan / Date