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Completed

NCT Number: NCT02699008

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

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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Key information

Conditions

Acute Coronary Syndrome Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wuhan Asia Heart Hospital

Wuhan, Hubei, 430022, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Stable CAD

Treatment and study plan

clopidogrel

Drug

Antiplatelet agent

Ticagrelor

Drug

New P2Y12 receptor inhibitor antiplatelet agent

Primary outcomes

  1. Major adverse cardiovascular events

    Time frame: 1 year

    stent thrombosis；ACS；all cause Death；stroke；

Secondary outcomes

  1. Bleeding events

    Time frame: 1 year

    gastrointestinal bleeding；gastrointestinal bleeding；other bleeding need RBC transfusion

Sponsors and collaborators

Lead sponsor

Wuhan Asia Heart Hospital

Other

Registry information

Official study 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

Acronym: HOPEmultiPFA

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 4, 2016
Registry last updated
Mar 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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