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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 : January 25, 2018
Information provided by (Responsible Party):
Rolf Kreutz, Indiana University

Brief Summary:
Randomized controlled study to examine physician use of pharmacogenetic information in patients receiving antiplatelet medication after percutaneous coronary intervention (PCI).

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Genetic: CYP2C19 genotyping Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 270 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: IU Health Krannert Personalized Medicine Study - Influencing Prescriber Behavior for the Use of Clopidogrel
Study Start Date : November 2016
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2018

Arm Intervention/treatment
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
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.

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. Death, Myocardial Infarction, Stroke [ Time Frame: one year ]
    Combined incidence of either death, myocardial infarction or stroke during follow up

  2. Stent Thrombosis [ Time Frame: one year ]
    Combined incidence of stent thrombosis according to Academic Research Consortium definitions during follow up

  3. Urgent target vessel revascularization [ Time Frame: one year ]
    Incidence of urgent target revascularization

  4. Major and Minor Bleeding [ Time Frame: one year ]
    Incidence of Major or Minor Bleeding according to GUSTO criteria during follow up

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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 identifier (NCT number): NCT02955121

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Contact: Rolf Kreutz, MD 3179620500
Contact: Judy Foltz 3172740981

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United States, Indiana
Indiana University Health Methodist Hospital Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Rolf Kreutz, MD    317-962-0500   
Sponsors and Collaborators
Indiana University
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Principal Investigator: Rolf Kreutz, MD Indiana University

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Responsible Party: Rolf Kreutz, MD. Associate Professor of Clinical Medicine, Indiana University Identifier: NCT02955121     History of Changes
Other Study ID Numbers: 1408765880
First Posted: November 4, 2016    Key Record Dates
Last Update Posted: January 25, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified Data Sharing only

Keywords provided by Rolf Kreutz, Indiana University:
Cytochrome P-450 CYP2C19
Platelet Aggregation Inhibitors
Percutaneous Coronary Intervention

Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Platelet Aggregation Inhibitors