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Platelet Reactivity After an Eastern Asian Loading Dose of Prasugrel in Taiwanese Patients With Acute Myocardial Infarction: PREP-TAMI Study
Prasugrel has a faster onset of action and greater platelet inhibition with less inter-individual response variability than clopidogrel. Japan and Taiwan are the only two nations where adjusted/Asian dose of prasugrel (loading dose (LD)/maintenance (MD): 20/3.75 mg) was approved for clinical use. However, there is no data regarding the effectiveness of adjusted dose of prasugrel on platelet reactivity in Taiwanese patients with acute coronary syndrome (ACS). This study aim to evaluate the pharmacodynamic of the Asian dose prasugrel on the platelet reactivity after percutaneous coronary intervention (PCI) for patients with ACS.
Rationale and Background Prasugrel provides more potent and rapid platelet inhibition compared to Clopidogrel. Rapid and effective inhibition of the platelet P2Y12 receptor is of pivotal importance in patients with AMI who undergo PCI. Prasugrel (60 mg loading and 10 mg/day maintenance dose) is a new generation P2Y12 inhibitor that achieves greater and faster platelet inhibition comparing with clopidogrel in patients undergoing PCI. As revealed by 2 head-to-head studies, reducing Prasugrel dosages to 20/3.75 LD/MD (mg) was still efficacious but led to less bleeding events than the original 60/10 LD/MD (mg). In TRITON-TIMI 38 trial, prasugrel was associated with not only significantly less ischemic events but also more non-CABG TIMI major bleeding, as compared to Clopidogrel. In the PRASFIT-ACS study from Japan (20 mg loading and 3.75 mg/day maintenance dose), prasugrel was associated with a 23% reduction of MACE and the incidence of non-CABG major bleeding was similar to clopidogrel. There is NO data regarding the effectiveness of Japanese loading dose of prasugrel on platelet reactivity in Taiwanese patients with AMI. This study use PRU for efficacy and ISTH major bleeding for safety evaluations; the anticipated results are prompt and effective platelet inhibition as well as comparably low bleeding rate.
Age
20 - No limit years
Sex
ALL
Healthy Volunteers
No
Feng Yuan Hospital
Taichung, Taiwan
Start Date
May 1, 2020
Primary Completion Date
April 1, 2021
Completion Date
May 1, 2021
Last Updated
February 26, 2021
45
ESTIMATED participants
P2Y12-reaction-units (PRU) by VerifyNow-P2Y12 assay
DIAGNOSTIC_TEST
Lead Sponsor
Feng Yuan Hospital, Ministry of Health and Welfare
Collaborators
NCT05548530
NCT07466719
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT07458880