IU Health Krannert Personalized Medicine Study

Indiana University

Status: Terminated

Conditions: Coronary Artery Disease

Treatments: Other: Prescriber Access to Genetic Information

Study type: Interventional

Funder types: Other

Identifiers

NCT02955121

1408765880

Details and patient eligibility

About

Randomized controlled study to examine physician use of pharmacogenetic information in patients receiving antiplatelet medication after percutaneous coronary intervention (PCI).

Full 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.

Enrollment: 107 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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107 participants in 2 patient groups

Pharmacogenetic Results Available to Provider

Active Comparator group

Description:

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

Treatment:

Other: Prescriber Access to Genetic Information

Control Arm

No Intervention group

Description:

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.