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High On-treatment Platelet Reactivity Identified by Multiple Platelet Function Assay

NCT ID: NCT02699008

Last Updated: 2016-03-04

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

477 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-10-31

Brief Summary

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High on-treatment platelet reactivity to adenosine diphosphate was a important reason to cause ischemic events in antiplatelet therapy. Using single testing to definite HPR may miss the "true HPR" or over estimate HPR, which may lead to randomized trials failed. It is not known whether combined multiple platelet function testing could assist to ensure"ture"HPR and improve clinical outcomes.

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Detailed Description

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This was a single-center, randomized, prospective study. ACS patients undergoing PCI treated with clopidogrel and aspirin were included. in the 3-5th day after prescription of clopidogrel, platelet function were tested simultaneously by three methods: MPAADP by Light transmittance aggregometry（LTA）, MAADP by Thrombelastography (TEG) ,and CTP2Y by Innovance PFA-200 . According to three result（Two of three or all three results higher than cutoff value was identified as HPR, MPALTA\>50%;MAADP\>47mm;CTP2Y\<106s）.Patients was defined as HPR(n=125) or unHPR(n=232), HPR patients were divided into HPR-Ticagrelor(HPR-T)and HPR-Clopidogrel(HPR-C) randomized. HPR-T group(n=77) patients' antiplatelet agents changed to ticagrelor, both unHPR and HPR-C groups keep unchanged(Clopidogrel). The major adverse cardiovascular events (MACE) were recorded during 1 year Follow-up.

Conditions

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Acute Coronary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HPR-Ticagrelor row

ACS patients aftergoing PCI treated with clopidogrel and aspirin were included. in the 3-5th day after prescription of clopidogrel, platelet function were tested simultaneously by three methods: Light transmittance aggregometry（LTA）, Thrombelastography (TEG) ,Innovance PFA-200 . According to three method results（Two of three or all three results higher than cutoff value was identified as HPR, MPALTA\>50%;MAADP\>47mm;CTP2Y\<106s）.Patients was defined as HPR and unHPR, HPR patients were randomized divided into HPR-Ticagrelor(HPR-T) and HPR-Clopidogrel(HPR-C)

Group Type ACTIVE_COMPARATOR

Ticagrelor

Intervention Type DRUG

New P2Y12 receptor inhibitor antiplatelet agent

HPR-Clopidogrel row

Thrombelastography (TEG) ,Innovance PFA-200 . According to three method results（Two of three or all three results higher than cutoff value was identified as HPR, MPALTA\>50%;MAADP\>47mm;CTP2Y\<106s）.Patients was defined as HPR and unHPR, HPR patients were randomized divided into HPR-Ticagrelor(HPR-T) and HPR-Clopidogrel(HPR-C)

Group Type ACTIVE_COMPARATOR

Clopidogrel

Intervention Type DRUG

Antiplatelet agent

unHPR row

Thrombelastography (TEG) ,Innovance PFA-200 . According to three method results（Two of three or all three results higher than cutoff value was identified as HPR, MPALTA\>50%;MAADP\>47mm;CTP2Y\<106s）.Patients was defined as HPR and unHPR, HPR patients were randomized divided into HPR-Ticagrelor(HPR-T) and HPR-Clopidogrel(HPR-C)

Group Type ACTIVE_COMPARATOR

Clopidogrel

Intervention Type DRUG

Antiplatelet agent

Interventions

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Clopidogrel

Antiplatelet agent

Intervention Type DRUG

Ticagrelor

New P2Y12 receptor inhibitor antiplatelet agent

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* ACS patients（UAP;USTEMI,STEMI）
* Undergoing PCI
* Oral antiplatelet therapy

Exclusion Criteria

* Stable CAD
Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wuhan Asia Heart Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Zhou xin, MD

Role: STUDY_CHAIR

Wuhan Asia Heart Hospital

Locations

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Wuhan Asia Heart Hospital

Wuhan, Hubei, China

Site Status

Countries

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China

Other Identifiers

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PFT-2015-01

Identifier Type: -

Identifier Source: org_study_id

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