IU Health Krannert Personalized Medicine Study - Influencing Prescriber Behavior for the Use of Clopidogrel
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Coronary Artery Disease
- Sponsor
- Indiana University
- Enrollment
- 107
- Locations
- 1
- Primary Endpoint
- Change in prescription of antiplatelet therapy
- Status
- Terminated
- Last Updated
- 5 years ago
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.
Investigators
Rolf Kreutz
MD. Associate Professor of Clinical Medicine
Indiana University
Eligibility Criteria
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.
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)