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IU Health Krannert Personalized Medicine Study

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02955121
Recruitment Status : Recruiting
First Posted : November 4, 2016
Last Update Posted : May 30, 2019
Information provided by (Responsible Party):
Rolf Kreutz, Indiana University

Tracking Information
First Submitted Date  ICMJE October 7, 2016
First Posted Date  ICMJE November 4, 2016
Last Update Posted Date May 30, 2019
Study Start Date  ICMJE November 2016
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 2, 2016)
Change in prescription of antiplatelet therapy [ Time Frame: one year ]
Number of individuals whose initial P2Y12 inhibitor therapy was changed to another P2Y12 inhibitor during time of follow up
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02955121 on Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 2, 2016)
  • Death, Myocardial Infarction, Stroke [ Time Frame: one year ]
    Combined incidence of either death, myocardial infarction or stroke during follow up
  • Stent Thrombosis [ Time Frame: one year ]
    Combined incidence of stent thrombosis according to Academic Research Consortium definitions during follow up
  • Urgent target vessel revascularization [ Time Frame: one year ]
    Incidence of urgent target revascularization
  • Major and Minor Bleeding [ Time Frame: one year ]
    Incidence of Major or Minor Bleeding according to GUSTO criteria during follow up
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 IU Health Krannert Personalized Medicine Study
Official Title  ICMJE IU Health Krannert Personalized Medicine Study - Influencing Prescriber Behavior for the Use of Clopidogrel
Brief Summary Randomized controlled study to examine physician use of pharmacogenetic information in patients receiving antiplatelet medication after percutaneous coronary intervention (PCI).
Detailed Description The study will randomize patients who have completed PCI and who are prescribed dual antiplatelet therapy to a genotype guided arm, in which CYP2C19 pharmacogenetic testing will be performed and a standard therapy arm without genetic testing. The study will examine the impact of pharmacogenetic testing on physician medication choice and clinical outcomes.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Coronary Artery Disease
Intervention  ICMJE Genetic: CYP2C19 genotyping
Study Arms  ICMJE
  • Active Comparator: Pharmacogenetic Testing Arm
    Genotyping for CYP2C19 variants is performed. The test results are integrated into the electronic health record and alerts are displayed to the prescriber. The ultimate decision regarding antiplatelet therapy is left to the prescriber
    Intervention: Genetic: CYP2C19 genotyping
  • No Intervention: Control Arm
    No genotyping information is performed as part of clinical care. Standard therapy is followed. Genotyping will be performed at conclusion of study in control arm, and genotyping results will not be incorporated into electronic health record.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 2, 2016)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2019
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with ischemic heart disease, who are prescribed dual antiplatelet therapy after percutaneous coronary intervention (PCI). Enrollment has to occur during index hospitalization or during outpatient visit for cath lab procedure.

Exclusion Criteria:

  • Pregnant or breastfeeding.
  • Unwilling or unable, in the opinion of the investigator, to comply with instructions on prescribed medicines.
  • Prior known allergy or intolerance to clopidogrel.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Rolf Kreutz, MD 3179620500
Contact: Judy Foltz 3172740981
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT02955121
Other Study ID Numbers  ICMJE 1408765880
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: De-identified Data Sharing only
Responsible Party Rolf Kreutz, Indiana University
Study Sponsor  ICMJE Indiana University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Rolf Kreutz, MD Indiana University
PRS Account Indiana University
Verification Date May 2019

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