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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Acute Coronary Syndrome, Hemorrhage, Treatment Side Effects

Intervention / Treatment
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* Diagnostic Test: P2Y12-reaction-units (PRU) by VerifyNow-P2Y12 assay


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Efient group<br>ACS patients who received oral Prasugrel after coronary angiography been done | Diagnostic Test: P2Y12-reaction-units (PRU) by VerifyNow-P2Y12 assay<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| platelet reactivity (PRU) after loading of prasugrel at 12 hours | PRU 12 hours after a loading dose | 12 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| platelet reactivity (PRU) after loading of prasugrel at 1 hour | PRU 1 hour after a loading dose | one hour | 
| platelet reactivity (PRU) after loading of prasugrel at 3 hours | PRU 3 hours after a loading dose | 3 hours | 
| platelet reactivity (PRU) after loading of prasugrel at 48 hours | PRU 48 hours after a loading dose | 48 hours | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prasugrel, Acute Coronary Syndrome, VerifyNow-P2Y12 assay