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High On-treatment Platelet Reactivity Identified by Multiple Platelet Function Assay (HOPEmultiPFA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02699008
Recruitment Status : Completed
First Posted : March 4, 2016
Last Update Posted : March 4, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Drug: Clopidogrel Drug: Ticagrelor Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 477 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : January 2014
Actual Primary Completion Date : August 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Major adverse cardiovascular events [ Time Frame: 1 year ]
    stent thrombosis;ACS;all cause Death;stroke;


Secondary Outcome Measures :
  1. Bleeding events [ Time Frame: 1 year ]
    gastrointestinal bleeding;gastrointestinal bleeding;other bleeding need RBC transfusion



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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Stable CAD

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02699008


Locations
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China, Hubei
Wuhan Asia Heart Hospital
Wuhan, Hubei, China, 430022
Sponsors and Collaborators
Wuhan Asia Heart Hospital
Investigators
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Study Chair: Zhou xin, MD Wuhan Asia Heart Hospital
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Responsible Party: Wuhan Asia Heart Hospital
ClinicalTrials.gov Identifier: NCT02699008    
Other Study ID Numbers: PFT-2015-01
First Posted: March 4, 2016    Key Record Dates
Last Update Posted: March 4, 2016
Last Verified: February 2016
Keywords provided by Wuhan Asia Heart Hospital:
clopidogrel;antiplatelet therapy
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Clopidogrel
Ticagrelor
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs