Clinical and Economic Implications of Genetic Testing for Warfarin Management

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

359 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2014-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Blood Coagulation Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Clinically Guided Cohort

Estimated Effective Warfarin dosing calculations are based on clinical data algorithms

Group Type ACTIVE_COMPARATOR

Warfarin

Intervention Type DRUG

Dose estimates will be suggested daily for initial dose given and up to 4 consecutive doses after initial dose.

Pharmacogenetically Guided Cohort

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

Group Type EXPERIMENTAL

Warfarin

Intervention Type DRUG

Dose estimates will be suggested daily for initial dose given and up to 4 consecutive doses after initial dose.

Interventions

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Warfarin

Dose estimates will be suggested daily for initial dose given and up to 4 consecutive doses after initial dose.

Intervention Type DRUG

Other Intervention Names

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Coumadin

Eligibility Criteria

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Inclusion Criteria

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