IU Health Krannert Personalized Medicine Study

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

Detailed Description
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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.

Official Title
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IU Health Krannert Personalized Medicine Study - Influencing Prescriber Behavior for the Use of Clopidogrel

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Other: Prescriber Access to Genetic Information


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pharmacogenetic Results Available to Provider<br>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 | Other: Prescriber Access to Genetic Information<br> <br> |
| No Intervention: Control Arm<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in prescription of antiplatelet therapy | Number of individuals whose initial P2Y12 inhibitor therapy was changed to another P2Y12 inhibitor during time of follow up | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death, Myocardial Infarction, Stroke | Combined incidence of either death, myocardial infarction or stroke during follow up | one year | 
| Stent Thrombosis | Combined incidence of stent thrombosis according to Academic Research Consortium definitions during follow up | one year | 
| Urgent target vessel revascularization | Incidence of urgent target revascularization | one year | 
| Major and Minor Bleeding | Incidence of Major or Minor Bleeding according to GUSTO criteria during follow up | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cytochrome P-450 CYP2C19, Pharmacogenetics, Platelet Aggregation Inhibitors, Percutaneous Coronary Intervention