Clinical trial NCT04768582: Platelet Reactivity After an Eastern Asian Loading Dose of Prasugrel in Taiwanese ACS Patients
Official title: Platelet Reactivity After an Eastern Asian Loading Dose of Prasugrel in Taiwanese Patients With Acute Myocardial Infarction: PREP-TAMI Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Coronary Syndrome
Hemorrhage
Treatment Side Effects
Keywords: Acute Coronary Syndrome
Prasugrel
VerifyNow-P2Y12 assay
Lead sponsor: Feng Yuan Hospital, Ministry of Health and Welfare
Sponsor class: OTHER_GOV
Collaborators: name: Cheng-Hsin General Hospital
First posted: 2021-02-24
Enrollment: 45
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: platelet reactivity (PRU) after loading of prasugrel at 12 hours
timeFrame: 12 hours
Secondary outcomes:
measure: platelet reactivity (PRU) after loading of prasugrel at 1 hour
timeFrame: one hour
measure: platelet reactivity (PRU) after loading of prasugrel at 3 hours
timeFrame: 3 hours
measure: platelet reactivity (PRU) after loading of prasugrel at 48 hours
timeFrame: 48 hours
measure: ISTH Major bleeding
timeFrame: day 7 after a loading dose of prasugrel
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Feng Yuan Hospital
Study officials:
affiliation: Feng Yuang Hospital
name: CHEN RONG TSAO, M.D.
role: PRINCIPAL_INVESTIGATOR
References: