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

Study Overview
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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 ensuretureHPR and improve clinical outcomes.

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.

Official Title
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High On-treatment Platelet Reactivity to Adenosine Diphosphate Identified by Multiple Platelet Function Assay Guide to Modify Anti-platelet Strategy in Patients Undergoing Percutaneous Coronary Intervention

Conditions
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Acute Coronary Syndrome

Intervention / Treatment
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* Drug: Clopidogrel
* Drug: Ticagrelor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ACS patients（UAP;USTEMI,STEMI） Undergoing PCI Oral antiplatelet therapy Exclusion Criteria: Stable CAD

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: HPR-Ticagrelor row<br>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) | Drug: Ticagrelor<br>* New P2Y12 receptor inhibitor antiplatelet agent<br>|
| Active Comparator: HPR-Clopidogrel row<br>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) | Drug: Clopidogrel<br>* Antiplatelet agent<br>|
| Active Comparator: unHPR row<br>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) | Drug: Clopidogrel<br>* Antiplatelet agent<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse cardiovascular events | stent thrombosis；ACS；all cause Death；stroke； | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding events | gastrointestinal bleeding；gastrointestinal bleeding；other bleeding need RBC transfusion | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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clopidogrel；antiplatelet therapy