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Genotyping Influences Outcome of Coronary Artery Stenting (GENIUS)

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: 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

Tracking Information
First Submitted Date  ICMJE February 23, 2016
First Posted Date  ICMJE March 14, 2016
Last Update Posted Date March 14, 2016
Study Start Date  ICMJE September 2011
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 11, 2016)
Myocardial infarction and Death [ Time Frame: 1 year after index procedure ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 11, 2016)
  • Any death [ Time Frame: 1 year after index procedure ]
  • Cardiac death [ Time Frame: 1 year after index procedure ]
  • Myocardial infarction [ Time Frame: 1 year after index procedure ]
  • Stent thrombosis (acute, late, very late) [ Time Frame: 1 year after index procedure ]
  • Target lesion revascularization [ Time Frame: 1 year after index procedure ]
    Revascularization of in-stent restenosis which developed in previously implanted stent on index procedure
  • 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
  • Bleeding complication [ Time Frame: During index procedure ]
  • PRU [ Time Frame: Within index procedure ]
    Value which is measured with VerifyNow that can monitor platelet inhibition of clopidogrel
  • ARU [ Time Frame: Within index procedure ]
    Value which is measured with VerifyNow that can monitor platelet inhibition of aspirin
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Genotyping Influences Outcome of Coronary Artery Stenting
Official Title  ICMJE Prospective Multi-center Registry of Genotyping Related Clopidogrel in Percutaneous Coronary Intervention Patients
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Myocardial Ischemia
  • CLOPIDOGREL, POOR METABOLISM of (Disorder)
Intervention  ICMJE 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)
Study Arms  ICMJE 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
Intervention: Drug: Clopidogrel
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 11, 2016)
5000
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2016
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02707445
Other Study ID Numbers  ICMJE KUMC-GENIUS
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Do-sun Lim, Korea University Anam Hospital
Study Sponsor  ICMJE Korea University Anam Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Do-sun Lim, MD, PhD Cardiovascular center, Korea University Anam Hospital
PRS Account Korea University Anam Hospital
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP