Platelet Reactivity After an Eastern Asian Loading Dose of Prasugrel in Taiwanese ACS Patients
NCT ID: NCT04768582
Last Updated: 2021-02-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
45 participants
INTERVENTIONAL
2020-05-01
2021-05-01
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Efient group
ACS patients who received oral Prasugrel after coronary angiography been done
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).
Interventions
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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).
Eligibility Criteria
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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
* Active internal bleeding or has a history of a bleeding disorder (i.e. hemophilia).
* Severe liver disease; for example, cirrhosis.
20 Years
ALL
No
Sponsors
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Cheng-Hsin General Hospital
OTHER
Feng Yuan Hospital, Ministry of Health and Welfare
OTHER_GOV
Responsible Party
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Chen-Rong, Tsao M.D.
Chief of Cardiology
Principal Investigators
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CHEN RONG TSAO, M.D.
Role: PRINCIPAL_INVESTIGATOR
Feng Yuang Hospital
Locations
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Feng Yuan Hospital
Taichung, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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ChenRong Tsao, M.D.
Role: primary
Other Identifiers
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FYHIRB109001
Identifier Type: -
Identifier Source: org_study_id