Platelet Reactivity After an Eastern Asian Loading Dose of Prasugrel in Taiwanese ACS Patients (PREP-TAMI)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hemorrhage; Acute Coronary Syndrome; Treatment Side Effects
• Intervention / Treatment: Diagnostic test: P2Y12-reaction-units (PRU) by VerifyNow-P2Y12 assay

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.

• Study Type: Interventional
• Enrollment (Anticipated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ms. Hao-Yien Pan; Phone Number: 2400 +88625271180; Email: shine75726@gmail.com

Study Locations

• Taiwan
  • Taichung, Taiwan, 42055
    • Recruiting
    • Feng Yuan Hospital
    • Contact: ChenRong Tsao, M.D.; Phone Number: 5280 +886425271180; Email: tsaodr@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Efient group; ACS patients who received oral Prasugrel after coronary angiography been done	Diagnostic test: P2Y12-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).

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Feng Yuan Hospital, Ministry of Health and Welfare
• Collaborators: Cheng-Hsin General Hospital
• Investigators: Principal Investigator: CHEN RONG TSAO, M.D., Feng Yuang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2020
• Primary Completion (Anticipated): April 1, 2021
• Study Completion (Anticipated): May 1, 2021

Study Registration Dates

• First Submitted: February 18, 2021
• First Submitted That Met QC Criteria: February 22, 2021
• First Posted (Actual): February 24, 2021

Study Record Updates

• Last Update Posted (Actual): February 26, 2021
• Last Update Submitted That Met QC Criteria: February 25, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Prasugrel; Acute Coronary Syndrome; VerifyNow-P2Y12 assay
• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Hemorrhage; Acute Coronary Syndrome
• Other Study ID Numbers: FYHIRB109001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No