IU Health Krannert Personalized Medicine Study - Influencing Prescriber Behavior for the Use of Clopidogrel
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Indiana University
- Enrollment
- 107
- Locations
- 1
- Primary Endpoint
- Change in prescription of antiplatelet therapy
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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.
Arms & Interventions
Pharmacogenetic Results Available to Provider
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: Prescriber Access to Genetic Information (Other)
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.
Outcomes
Primary Outcomes
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 Outcomes
- Urgent target vessel revascularization(one year)
- Stent Thrombosis(one year)
- Major and Minor Bleeding(one year)
- Death, Myocardial Infarction, Stroke(one year)
Investigators
Rolf Kreutz
MD. Associate Professor of Clinical Medicine
Indiana University