NCT04768582

Platelet Reactivity After an Eastern Asian Loading Dose of Prasugrel in Taiwanese ACS Patients

Platelet Reactivity After an Eastern Asian Loading Dose of Prasugrel in Taiwanese Patients With Acute Myocardial Infarction: PREP-TAMI Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Feng Yuan Hospital, Ministry of Health and Welfare · Other Government
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Acute Coronary Syndrome
• Hemorrhage
• Treatment Side Effects

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	P2Y12-reaction-units (PRU) by VerifyNow-P2Y12 assay	The efficacy endpoint was platelet reactivity, of which was serially assessed using the VerifyNow-P2Y12 assay and the results were expressed as P2Y12-reaction-units (PRU).

Timeline

• Start date: 2020-05-01
• Primary completion: 2021-04-01
• Completion: 2021-05-01
• First posted: 2021-02-24
• Last updated: 2021-02-26

Locations

1 site across 1 country: Taiwan