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Genotyping Influences Outcome of Coronary Artery Stenting (GENIUS)

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ClinicalTrials.gov Identifier: NCT02707445
Recruitment Status : Completed
First Posted : March 14, 2016
Last Update Posted : March 14, 2016
Sponsor:
Information provided by (Responsible Party):
Do-sun Lim, Korea University Anam Hospital

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.

Condition or disease Intervention/treatment Phase
Myocardial Ischemia CLOPIDOGREL, POOR METABOLISM of (Disorder) Drug: Clopidogrel Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5000 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Prospective Multi-center Registry of Genotyping Related Clopidogrel in Percutaneous Coronary Intervention Patients
Study Start Date : September 2011
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: GENIUS
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
Drug: Clopidogrel
Administration of conventional dual anti-platelet treatment (aspirin 100mg and clopidogrel 75mg daily) for minimum 3 months after percutaneous coronary intervention
Other Name: clopidogrel hydrogen sulfate 97.875mg (75mg as clopidogrel)




Primary Outcome Measures :
  1. Myocardial infarction and Death [ Time Frame: 1 year after index procedure ]

Secondary Outcome Measures :
  1. Any death [ Time Frame: 1 year after index procedure ]
  2. Cardiac death [ Time Frame: 1 year after index procedure ]
  3. Myocardial infarction [ Time Frame: 1 year after index procedure ]
  4. Stent thrombosis (acute, late, very late) [ Time Frame: 1 year after index procedure ]
  5. Target lesion revascularization [ Time Frame: 1 year after index procedure ]
    Revascularization of in-stent restenosis which developed in previously implanted stent on index procedure

  6. Stroke [ Time Frame: 1 year after index procedure ]
    Ischemic or hemorrhagic cerebral infarction diagnosed by brain MRI which developed within 1 year after index procedure

  7. Bleeding complication [ Time Frame: During index procedure ]
  8. PRU [ Time Frame: Within index procedure ]
    Value which is measured with VerifyNow that can monitor platelet inhibition of clopidogrel

  9. ARU [ Time Frame: Within index procedure ]
    Value which is measured with VerifyNow that can monitor platelet inhibition of aspirin



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT02707445


Sponsors and Collaborators
Korea University Anam Hospital
Investigators
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Principal Investigator: Do-sun Lim, MD, PhD Cardiovascular center, Korea University Anam Hospital

Publications of Results:
Wright RS, Anderson JL, Adams CD, Bridges CR, Casey DE Jr, Ettinger SM, Fesmire FM, Ganiats TG, Jneid H, Lincoff AM, Peterson ED, Philippides GJ, Theroux P, Wenger NK, Zidar JP, Anderson JL, Adams CD, Antman EM, Bridges CR, Califf RM, Casey DE Jr, Chavey WE 2nd, Fesmire FM, Hochman JS, Levin TN, Lincoff AM, Peterson ED, Theroux P, Wenger NK, Wright RS. 2011 ACCF/AHA focused update of the Guidelines for the Management of Patients with Unstable Angina/Non-ST-Elevation Myocardial Infarction (updating the 2007 guideline): a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines developed in collaboration with the American College of Emergency Physicians, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons. J Am Coll Cardiol. 2011 May 10;57(19):1920-59. doi: 10.1016/j.jacc.2011.02.009. Epub 2011 Mar 28. Erratum in: J Am Coll Cardiol. 2011 May 10;57(19):1960.

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Responsible Party: Do-sun Lim, MD, PhD, Korea University Anam Hospital
ClinicalTrials.gov Identifier: NCT02707445     History of Changes
Other Study ID Numbers: KUMC-GENIUS
First Posted: March 14, 2016    Key Record Dates
Last Update Posted: March 14, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Clopidogrel
Ischemia
Myocardial Ischemia
Coronary Artery Disease
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
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