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Genotyping Influences Outcome of Coronary Artery Stenting (GENIUS)

Primary Purpose

Myocardial Ischemia, CLOPIDOGREL, POOR METABOLISM of (Disorder)

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Clopidogrel
Sponsored by
Korea University Anam Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Myocardial Ischemia

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Written informed consent
  • Older than 20 years
  • All percutaneous coronary intervention patients within 1 month

Exclusion Criteria:

  • Pregnancy
  • Life expectancy below 1 year
  • Known aspirin or clopidogrel allergy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    GENIUS

    Arm Description

    All comer patients who had undergone percutaneous coronary intervention with administration of conventional dual anti-platelet treatment (aspirin 100mg and clopidogrel 75mg daily) for minimum 3 months

    Outcomes

    Primary Outcome Measures

    Myocardial infarction and Death

    Secondary Outcome Measures

    Any death
    Cardiac death
    Myocardial infarction
    Stent thrombosis (acute, late, very late)
    Target lesion revascularization
    Revascularization of in-stent restenosis which developed in previously implanted stent on index procedure
    Stroke
    Ischemic or hemorrhagic cerebral infarction diagnosed by brain MRI which developed within 1 year after index procedure
    Bleeding complication
    PRU
    Value which is measured with VerifyNow that can monitor platelet inhibition of clopidogrel
    ARU
    Value which is measured with VerifyNow that can monitor platelet inhibition of aspirin

    Full Information

    First Posted
    February 23, 2016
    Last Updated
    March 11, 2016
    Sponsor
    Korea University Anam Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02707445
    Brief Title
    Genotyping Influences Outcome of Coronary Artery Stenting
    Acronym
    GENIUS
    Official Title
    Prospective Multi-center Registry of Genotyping Related Clopidogrel in Percutaneous Coronary Intervention Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2011 (undefined)
    Primary Completion Date
    February 2016 (Actual)
    Study Completion Date
    February 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Korea University Anam Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study evaluated epidemiology and clinical outcome of clopidogrel related various genotyping in Korean patients who had undergone percutaneous coronary intervention as a all comer registry form.
    Detailed Description
    This study evaluates the relationship between clopidogrel related various genotyping, epidemiology and clinical outcome of patient who had undergone percutaneous coronary intervention. Clopidogrel resistance was measured with VerifyNow, which is a device that can monitor platelet inhibition of clopidogrel. Genes which are known to be related with clopidogrel resistance were evaluated; (1-3) CYP 2C19 *2, *3, *17, (4) PON1 Q192R, (5) ABCB1 3435C->T, (6) P2Y12, (7) CYP 2C9 *3.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Myocardial Ischemia, CLOPIDOGREL, POOR METABOLISM of (Disorder)

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    5000 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    GENIUS
    Arm Type
    Experimental
    Arm Description
    All comer patients who had undergone percutaneous coronary intervention with administration of conventional dual anti-platelet treatment (aspirin 100mg and clopidogrel 75mg daily) for minimum 3 months
    Intervention Type
    Drug
    Intervention Name(s)
    Clopidogrel
    Other Intervention Name(s)
    clopidogrel hydrogen sulfate 97.875mg (75mg as clopidogrel)
    Intervention Description
    Administration of conventional dual anti-platelet treatment (aspirin 100mg and clopidogrel 75mg daily) for minimum 3 months after percutaneous coronary intervention
    Primary Outcome Measure Information:
    Title
    Myocardial infarction and Death
    Time Frame
    1 year after index procedure
    Secondary Outcome Measure Information:
    Title
    Any death
    Time Frame
    1 year after index procedure
    Title
    Cardiac death
    Time Frame
    1 year after index procedure
    Title
    Myocardial infarction
    Time Frame
    1 year after index procedure
    Title
    Stent thrombosis (acute, late, very late)
    Time Frame
    1 year after index procedure
    Title
    Target lesion revascularization
    Description
    Revascularization of in-stent restenosis which developed in previously implanted stent on index procedure
    Time Frame
    1 year after index procedure
    Title
    Stroke
    Description
    Ischemic or hemorrhagic cerebral infarction diagnosed by brain MRI which developed within 1 year after index procedure
    Time Frame
    1 year after index procedure
    Title
    Bleeding complication
    Time Frame
    During index procedure
    Title
    PRU
    Description
    Value which is measured with VerifyNow that can monitor platelet inhibition of clopidogrel
    Time Frame
    Within index procedure
    Title
    ARU
    Description
    Value which is measured with VerifyNow that can monitor platelet inhibition of aspirin
    Time Frame
    Within index procedure

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Written informed consent Older than 20 years All percutaneous coronary intervention patients within 1 month Exclusion Criteria: Pregnancy Life expectancy below 1 year Known aspirin or clopidogrel allergy
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Do-sun Lim, MD, PhD
    Organizational Affiliation
    Cardiovascular center, Korea University Anam Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
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