IU Health Krannert Personalized Medicine Study

NCT ID: NCT02955121

Last Updated: 2020-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

107 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2020-01-15

Brief Summary

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

Detailed Description

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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.

Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Pharmacogenetic Results Available to Provider

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

Group Type ACTIVE_COMPARATOR

Prescriber Access to Genetic Information

Intervention Type OTHER

Control Arm

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Prescriber Access to Genetic Information

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Indiana University

OTHER

Sponsor Role lead

Responsible Party

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Rolf Kreutz

MD. Associate Professor of Clinical Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rolf Kreutz, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

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Indiana University Health Methodist Hospital

Indianapolis, Indiana, United States

Site Status

Countries

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United States

Other Identifiers

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1408765880

Identifier Type: -

Identifier Source: org_study_id

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