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Slower than anticipated recruitment
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Randomized controlled study to examine physician use of pharmacogenetic information in patients receiving antiplatelet medication after percutaneous coronary intervention (PCI).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pharmacogenetic Results Available to Provider | Active Comparator | 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 |
|
| Control Arm | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prescriber Access to Genetic Information | Other |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rolf Kreutz, MD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Health Methodist Hospital | Indianapolis | Indiana | 46202 | United States |
De-identified Data Sharing only
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 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 |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |