Clinical and Economic Implications of Genetic Testing for Warfarin Management

Phase 4

Completed

• Conditions: Blood Coagulation Disorders
• Interventions: Drug: Warfarin

• Registration Number: NCT00964353
• Lead Sponsor: University of Chicago

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-08-12
• Study First Submitted QC: 2009-08-21
• Study First Posted: 2009-08-24
• Primary Completion: 2012-08
• Study Completion: 2014-04
• Status Verified: 2019-10
• Results First Submitted: 2019-10-08
• Results First Submitted QC: 2019-11-06
• Last Update Submitted: 2019-11-06
• Results First Posted: 2019-11-25
• Last Update Posted: 2019-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 359

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pharmacogenetically Guided Cohort	Warfarin	Estimated Effective Warfarin dosing calculations are based on genetic and clinical data algorithms.
Clinically Guided Cohort	Warfarin	Estimated Effective Warfarin dosing calculations are based on clinical data algorithms

Primary Outcome Measures

Name	Time	Method
Inpatient Length of Stay	during hospital stay, up to 60 days	Inpatient length of stay

Secondary Outcome Measures

Name	Time	Method
Supratherapeutic Dosing	during hospital stay, up to 60 days	International Normalized Ratio

Trial Locations

Locations (1)

University of Chicago; 🇺🇸 Chicago, Illinois, United States