IU Health Krannert Personalized Medicine Study
- Conditions
- Coronary Artery Disease
- Interventions
- Other: Prescriber Access to Genetic Information
- Registration Number
- NCT02955121
- Lead Sponsor
- Indiana University
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 107
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pharmacogenetic Results Available to Provider Prescriber Access to Genetic Information 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
- Primary Outcome Measures
Name Time Method Change in prescription of antiplatelet therapy one year Number of individuals whose initial P2Y12 inhibitor therapy was changed to another P2Y12 inhibitor during time of follow up
- Secondary Outcome Measures
Name Time Method Urgent target vessel revascularization one year Incidence of urgent target revascularization
Major and Minor Bleeding one year Incidence of Major or Minor Bleeding according to GUSTO criteria during follow up
Stent Thrombosis one year Combined incidence of stent thrombosis according to Academic Research Consortium definitions during follow up
Death, Myocardial Infarction, Stroke one year Combined incidence of either death, myocardial infarction or stroke during follow up
Trial Locations
- Locations (1)
Indiana University Health Methodist Hospital
🇺🇸Indianapolis, Indiana, United States