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IU Health Krannert Personalized Medicine Study

Not Applicable
Terminated
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
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.
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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.
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Pharmacogenetic Results Available to ProviderPrescriber Access to Genetic InformationGenotyping 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
NameTimeMethod
Change in prescription of antiplatelet therapyone year

Number of individuals whose initial P2Y12 inhibitor therapy was changed to another P2Y12 inhibitor during time of follow up

Secondary Outcome Measures
NameTimeMethod
Urgent target vessel revascularizationone year

Incidence of urgent target revascularization

Major and Minor Bleedingone year

Incidence of Major or Minor Bleeding according to GUSTO criteria during follow up

Stent Thrombosisone year

Combined incidence of stent thrombosis according to Academic Research Consortium definitions during follow up

Death, Myocardial Infarction, Strokeone 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

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