Coronary Artery Disease
Conditions
Keywords
Cytochrome P-450 CYP2C19, Pharmacogenetics, Platelet Aggregation Inhibitors, Percutaneous Coronary Intervention
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.
Interventions
OTHERPrescriber Access to Genetic Information
Sponsors
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Death, Myocardial Infarction, Stroke | one year | Combined incidence of either death, myocardial infarction or stroke during follow up |
| Stent Thrombosis | one year | Combined incidence of stent thrombosis according to Academic Research Consortium definitions during follow up |
| 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 |
Countries
United States
Outcome results
None listed