Acute Coronary Syndrome, Hemorrhage, Treatment Side Effects
Conditions
Keywords
Acute Coronary Syndrome, Prasugrel, VerifyNow-P2Y12 assay
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. 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.
Interventions
DIAGNOSTIC_TESTP2Y12-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).
Sponsors
Cheng-Hsin General Hospital
Feng Yuan Hospital, Ministry of Health and Welfare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| platelet reactivity (PRU) after loading of prasugrel at 12 hours | 12 hours | PRU 12 hours after a loading dose |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| platelet reactivity (PRU) after loading of prasugrel at 1 hour | one hour | PRU 1 hour after a loading dose |
| platelet reactivity (PRU) after loading of prasugrel at 3 hours | 3 hours | PRU 3 hours after a loading dose |
| platelet reactivity (PRU) after loading of prasugrel at 48 hours | 48 hours | PRU 48 hours after a loading dose |
| ISTH Major bleeding | day 7 after a loading dose of prasugrel | 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 |
Countries
Taiwan
Contacts
Primary ContactMs. Hao-Yien Pan
Outcome results
None listed