Ignite Creation Date:
2024-05-06 @ 3:48 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04768582
Status:
UNKNOWN
Last Update Posted:
2021-02-26
First Post:
2021-02-18
Brief Title:
Platelet Reactivity After an Eastern Asian Loading Dose of Prasugrel in Taiwanese ACS Patients
Sponsor:
Feng Yuan Hospital Ministry of Health and Welfare
Organization:
Feng Yuan Hospital Ministry of Health and Welfare
Study Overview
Official Title:
Platelet Reactivity After an Eastern Asian Loading Dose of Prasugrel in Taiwanese Patients With Acute Myocardial Infarction PREP-TAMI Study
Status:
UNKNOWN
Status Verified Date:
2021-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PREP-TAMI
Brief 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 adjustedAsian dose of prasugrel loading dose LDmaintenance MD 20375 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 mgday 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 20375 LDMD mg was still efficacious but led to less bleeding events than the original 6010 LDMD 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 375 mgday 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
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 mgday 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 20375 LDMD mg was still efficacious but led to less bleeding events than the original 6010 LDMD 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 375 mgday 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None