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

Acute Coronary Syndrome Clinical Trial

— PREP-TAMI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04768582
• Other study ID #: FYHIRB109001
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2020
• Est. completion date: May 1, 2021

Study information

• Verified date: February 2021
• Source: Feng Yuan Hospital, Ministry of Health and Welfare
• Contact: Ms. Hao-Yien Pan
• Phone: +88625271180
• Email: shine75726[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: May 1, 2021
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Age>=20
• Mentally competent to provide an informed consent.
• A person being diagnosed with acute coronary syndrome and arranged for a percutaneous coronary intervention.

Exclusion Criteria:

• A history of hemorrhagic stroke at any time in the past.
• Active internal bleeding or has a history of a bleeding disorder (i.e. hemophilia).
• Severe liver disease; for example, cirrhosis.

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Hemorrhage
• Treatment Side Effects

Intervention

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).

Locations

Country	Name	City	State
Taiwan	Feng Yuan Hospital	Taichung

Sponsors (2)

Lead Sponsor	Collaborator
Feng Yuan Hospital, Ministry of Health and Welfare	Cheng-Hsin General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	platelet reactivity (PRU) after loading of prasugrel at 12 hours	PRU 12 hours after a loading dose	12 hours
Secondary	platelet reactivity (PRU) after loading of prasugrel at 1 hour	PRU 1 hour after a loading dose	one hour
Secondary	platelet reactivity (PRU) after loading of prasugrel at 3 hours	PRU 3 hours after a loading dose	3 hours
Secondary	platelet reactivity (PRU) after loading of prasugrel at 48 hours	PRU 48 hours after a loading dose	48 hours
Secondary	ISTH Major bleeding	the definition recommended by the International Society on Thrombosis and Haemostasis (ISTH) defines major bleeding as fatal bleeding; symptomatic bleeding in a critical area or organ such as intracranial, intraspinal, intraocular resulting in vision changes, retroperitoneal, intraarticular, pericardial	day 7 after a loading dose of prasugrel