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

Not Applicable

Completed

• Conditions: Acute Coronary Syndrome
• Interventions: Drug: Ticagrelor; Drug: Clopidogrel

• Registration Number: NCT02699008
• Lead Sponsor: Wuhan Asia Heart Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2014-01
• Primary Completion: 2015-08
• Study Completion: 2015-10
• Study First Submitted: 2015-10-30
• Status Verified: 2016-02
• Study First Submitted QC: 2016-02-29
• Last Update Submitted: 2016-02-29
• Study First Posted: 2016-03-04
• Last Update Posted: 2016-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 477

Inclusion Criteria

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

Exclusion Criteria

• Stable CAD

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HPR-Ticagrelor row	Ticagrelor	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)
HPR-Clopidogrel row	Clopidogrel	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)
unHPR row	Clopidogrel	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)

Primary Outcome Measures

Name	Time	Method
Major adverse cardiovascular events	1 year	stent thrombosis；ACS；all cause Death；stroke；

Secondary Outcome Measures

Name	Time	Method
Bleeding events	1 year	gastrointestinal bleeding；gastrointestinal bleeding；other bleeding need RBC transfusion

Trial Locations

Locations (1)

Wuhan Asia Heart Hospital; 🇨🇳 Wuhan, Hubei, China