Clinical and Economic Implications of Genetic Testing for Warfarin Management

The University of Chicago

Status and phase: Completed; Phase 4

Conditions: Blood Coagulation Disorders

Treatments: Drug: Warfarin

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT00964353

16738B

Details and patient eligibility

About

The purpose of this study is to explore how knowing genes that individuals inherit from their parents can make warfarin dosing more safe and effective. This study is being done to determine whether providing doctors with data on the genes their patients inherited and warfarin dosing recommendations based on those genes affects the costs and outcomes of care and after hospitalization for patients from different ethnic/racial backgrounds, and how physicians use this information in decision making.

Full description

The overall goal of this project is to develop and assess the effectiveness and cost-effectiveness of strategies that use genetic testing in the management of anticoagulation among racially diverse hospitalized patients. The project has four specific aims.

Aim 1: To contribute patients initiating therapy at the University of Chicago Medical Center (UCMC) and affiliated hospitals to a genetic registry of a racially diverse set of patients undergoing warfarin therapy.

Aim 2: To perform a randomized trial to determine the efficacy, costs and cost-effectiveness of existing pharmacogenetic algorithms for the management of warfarin therapy among hospitalized patients of all races.

Aim 3: To develop clinical pharmacogenetic algorithms for the management of warfarin therapy among hospitalized African American patients.

Aim 4: To perform a randomized trial to determine and compare the efficacy, costs and cost-effectiveness of existing clinical and non-racially tailored pharmacogenetic algorithms to racially tailored pharmacogenetic algorithms for the management of warfarin therapy among hospitalized African American patients.

Enrollment: 359 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• warfarin-naive patients
• ages 18 and older
• are undergoing inpatient anticoagulation initiation with warfarin for diagnoses that necessitate anticoagulation

Exclusion criteria

• patients who are not warfarin-naive
• 17 years of age or younger

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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359 participants in 2 patient groups

Clinically Guided Cohort

Active Comparator group

Description:

Estimated Effective Warfarin dosing calculations are based on clinical data algorithms

Treatment:

Drug: Warfarin

Pharmacogenetically Guided Cohort

Experimental group

Description:

Estimated Effective Warfarin dosing calculations are based on genetic and clinical data algorithms.

Treatment:

Drug: Warfarin