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PRACTICE: Platelet Reactivity And Clinical ThrombotIC Events Study

Sponsor
Shenyang Northern Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03525145
Collaborator
(none)
1,500
Enrollment
1
Location
21
Anticipated Duration (Months)
71.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Platelet function testing has been considered for DAPT strategy adjustments to reduce the patient's risk of ischemia and bleeding. Although several previous RCT studies did not find any benefit in the detection of platelet function， the previous studies were mostly low-risk populations, and the P2Y12 receptor antagonists were simply clopidogrel, and the detection methods were relatively simple. Therefore, the need for platelet monitoring in high-risk ACS patients receiving new potent P2Y12 inhibitor ticagrelor, as well as the diagnostic threshold for different platelet function assays needs further study. In addition, due to the differences on the response to anti-platelet drugs between the East and the West, it is not appropriate to simply refer to the conclusion of the other party. However, as of now, there is no large sample randomized controlled study systematically focused on the applicability and status of platelet function tests in East Asian populations, especially Chinese populations.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    1500 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Platelet Reactivity And Clinical ThrombotIC Events Study
    Actual Study Start Date :
    Sep 1, 2018
    Anticipated Primary Completion Date :
    May 31, 2020
    Anticipated Study Completion Date :
    May 31, 2020

    Outcome Measures

    Primary Outcome Measures

    1. Cardiovascular thrombotic events [One Year]

      Cardiovascular death, non-fatal myocardial infarction, stroke, or stent thrombosis

    Secondary Outcome Measures

    1. Cardiovascular death [One Year]

      Cardiovascular death

    2. BARC(Bleeding Academic Research Consortium )2-5 Bleeding [One Year]

      BARC2-5 Bleeding

    3. MACCE(Major adverse cardiac and cerebral events) [One Year]

      Cardiovascular death, non-fatal myocardial infarction, stroke, or ischemic-driven target vessel revascularization

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    1. Age 18-80 years old;

    2. There was a history of at least one acute coronary syndrome (ACS) attack within 14 days before enrollment, including unstable angina, non-ST elevation myocardial infarction, or ST-elevation myocardial infarction;

    3. Being treated with aspirin and a P2Y12 inhibitor (clopidogrel or ticagrelor);

    4. Plan to apply dual antiplatelet drugs (DAPT, aspirin + P2Y12 inhibitor) for at least 12 months;

    5. Voluntary signature of informed consent

    Exclusion Criteria:

    1. In combination with other anti-platelet drugs, such as cilostazol;

    2. Have received glycoprotein IIb/IIIa inhibitor within 72 hours before enrollment;

    3. receving a P2Y12 inhibitor loading does less than 72h or maintenance (unloaded) less than 5d;

    4. Plan to perform any coronary revascularization within 30 days;

    5. The need for oral anticoagulants (warfarin, factor II or factor X inhibitors);

    6. Predicted survival time <12 months for patients with known severe progressive disease (such as malignancy) or extreme depletion of the disease;

    7. pregnant women or pregnant people;

    8. Any situation that may interfere with the research process, such as dementia, delirium, alcoholism, etc.;

    9. expected to undergo surgery within 1 year;

    10. Patients participating in other ongoing clinical studies

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Northern Hospital Shenyang Liaoning China

    Sponsors and Collaborators

    • Shenyang Northern Hospital

    Investigators

    • Study Director: Yaling Han, MD, Northern Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Han Yaling, Prof., Shenyang Northern Hospital
    ClinicalTrials.gov Identifier:
    NCT03525145
    Other Study ID Numbers:
    • PRACTICEV1.02
    First Posted:
    May 15, 2018
    Last Update Posted:
    Jan 4, 2019
    Last Verified:
    Jan 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Han Yaling, Prof., Shenyang Northern Hospital
    Platelet Reactivity
    Thrombotic Events
    Additional relevant MeSH terms:
    Acute Coronary Syndrome

    Study Results

    No Results Posted as of Jan 4, 2019