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

NCT04768582 | Unknown

• 1 other identifier: FYHIRB109001
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Coronary Syndrome; Hemorrhage; Treatment Side Effects

Keywords

Acute Coronary Syndrome; Prasugrel; VerifyNow-P2Y12 assay

Outcome Measures

Primary Outcomes (1)

• platelet reactivity (PRU) after loading of prasugrel at 12 hours

  PRU 12 hours after a loading dose

  12 hours

Secondary Outcomes (4)

• platelet reactivity (PRU) after loading of prasugrel at 1 hour

  one hour

• platelet reactivity (PRU) after loading of prasugrel at 3 hours

  3 hours

• platelet reactivity (PRU) after loading of prasugrel at 48 hours

  48 hours

• ISTH Major bleeding

  day 7 after a loading dose of prasugrel

Study Arms (1)

Efient group

EXPERIMENTAL

ACS patients who received oral Prasugrel after coronary angiography been done

Diagnostic Test: P2Y12-reaction-units (PRU) by VerifyNow-P2Y12 assay

Interventions

P2Y12-reaction-units (PRU) by VerifyNow-P2Y12 assay DIAGNOSTIC_TEST

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).

Efient group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age\>=20
• Mentally competent to provide an informed consent.
• A person being diagnosed with acute coronary syndrome and arranged for a percutaneous coronary intervention.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Feng Yuan Hospital, Ministry of Health and Welfare: lead
• Cheng-Hsin General Hospital: collaborator

Study Sites (1)

Feng Yuan Hospital

Taichung, 42055, Taiwan

RECRUITING

MeSH Terms

Conditions

Acute Coronary Syndrome; Hemorrhage

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• CHEN RONG TSAO, M.D.

  Feng Yuang Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ms. Hao-Yien Pan

CONTACT

+88625271180; shine75726@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Cardiology

Study Record Dates

• First Submitted: February 18, 2021
• First Posted: February 24, 2021
• Study Start: May 1, 2020
• Primary Completion: April 1, 2021
• Study Completion: May 1, 2021
• Last Updated: February 26, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)