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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04768582
Other study ID # FYHIRB109001
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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