An interventional study of Prescriber Access to Genetic Information in Coronary Artery Disease, sponsored by Indiana University. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-07-28.
Sponsored by Indiana University · Not applicable, Interventional, and Health services research
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.
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's enrollment of 107 is below the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Indiana University is the lead sponsor of 958 studies on the registry; 200 are open to participants now.
Of its 142 completed or terminated interventional studies of FDA-regulated products, 112 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Other: Prescriber Access to Genetic Information
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.
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
Time frame: one year
Death, Myocardial Infarction, Stroke
Combined incidence of either death, myocardial infarction or stroke during follow up
Time frame: one year
Stent Thrombosis
Combined incidence of stent thrombosis according to Academic Research Consortium definitions during follow up
Time frame: one year
Urgent target vessel revascularization
Incidence of urgent target revascularization
Time frame: one year
Major and Minor Bleeding
Incidence of Major or Minor Bleeding according to GUSTO criteria during follow up
Time frame: one year
Plan to share: Yes — De-identified Data Sharing only
No publications or documents are linked to this record.
This study is terminated, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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Indiana University