HOPEmultiPFA: High On-treatment Platelet Reactivity Identified by Multiple Platelet Function Assay
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: 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) |
Drug: Ticagrelor
New P2Y12 receptor inhibitor antiplatelet agent
|
| Active Comparator: 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) |
Drug: Clopidogrel
Antiplatelet agent
|
| Active Comparator: 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) |
Drug: Clopidogrel
Antiplatelet agent
|
Outcome Measures
Primary Outcome Measures
- Major adverse cardiovascular events [1 year]
stent thrombosis；ACS；all cause Death；stroke；
Secondary Outcome Measures
- Bleeding events [1 year]
gastrointestinal bleeding；gastrointestinal bleeding；other bleeding need RBC transfusion
Eligibility Criteria
Criteria
Inclusion Criteria:
-
ACS patients（UAP;USTEMI,STEMI）
-
Undergoing PCI
-
Oral antiplatelet therapy
Exclusion Criteria:
- Stable CAD
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Wuhan Asia Heart Hospital | Wuhan | Hubei | China | 430022 |
Sponsors and Collaborators
- Wuhan Asia Heart Hospital
Investigators
- Study Chair: Zhou xin, MD, Wuhan Asia Heart Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PFT-2015-01