Platelet Reactivity After an Eastern Asian Loading Dose of Prasugrel in Taiwanese Patients With Acute Myocardial Infarction: PREP-TAMI Study
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 45
- Locations
- 2
- Primary Endpoint
- platelet reactivity (PRU) after loading of prasugrel at 12 hours
Study Overview
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 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Outcomes
Primary Outcomes
platelet reactivity (PRU) after loading of prasugrel at 12 hours
Time Frame: 12 hours
PRU 12 hours after a loading dose
Secondary Outcomes
- platelet reactivity (PRU) after loading of prasugrel at 1 hour(one hour)
- platelet reactivity (PRU) after loading of prasugrel at 48 hours(48 hours)
- platelet reactivity (PRU) after loading of prasugrel at 3 hours(3 hours)
- ISTH Major bleeding(day 7 after a loading dose of prasugrel)
Investigators
Chen-Rong, Tsao M.D.
Chief of Cardiology
Feng Yuan Hospital, Ministry of Health and Welfare