Clinical and Economic Implications of Genetic Testing for Warfarin Management

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Blood Coagulation Disorders	Drug: Warfarin	Phase 4

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 Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	268 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Other
Official Title:	The Hospital and Economics CERT: Project 1: The Clinical and Economic Implications of Genetic Testing for Warfarin Management
Study Start Date :	August 2009
Actual Primary Completion Date :	August 2012
Estimated Study Completion Date :	December 2018

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Active Comparator: Clinically Guided Cohort; Estimated Effective Warfarin dosing calculations are based on clinical data algorithms	Drug: Warfarin; Dose estimates will be suggested daily for initial dose given and up to 4 consecutive doses after initial dose.; Other Name: Coumadin
Experimental: Pharmacogenetically Guided Cohort; Estimated Effective Warfarin dosing calculations are based on genetic and clinical data algorithms.	Drug: Warfarin; Dose estimates will be suggested daily for initial dose given and up to 4 consecutive doses after initial dose.; Other Name: Coumadin

Outcome Measures

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Primary Outcome Measures :

1. Clinical outcomes and costs associated with the use of genetic testing will be compared to current standards of care and alternative management practices to assess the value of genotype-guided warfarin therapy algorithms for patients and payers. [ Time Frame: 30 days after discharge ]

Secondary Outcome Measures :

1. Clinical outcomes: inpatient length of stay, supratherapeutic dosing, time within range, and the incidence of deep venous thrombosis (DVT), stroke, pulmonary embolus (PE), gastrointestinal bleeding (GI) and intracranial hemorrhage (ICH). [ Time Frame: one year ]
2. Direct costs of interest include: hospital costs, genetic costs, medication costs, laboratory costs, and total therapy costs in aggregate and broken down by payer. [ Time Frame: 1 month after discharge ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637

Sponsors and Collaborators

University of Chicago

Agency for Healthcare Research and Quality (AHRQ)

Investigators

Principal Investigator:	David O Meltzer, MD, PhD	University of Chicago

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	University of Chicago
ClinicalTrials.gov Identifier:	NCT00964353 History of Changes
Other Study ID Numbers:	16738B
First Posted:	August 24, 2009
Last Update Posted:	January 25, 2017
Last Verified:	January 2017

Keywords provided by University of Chicago:

coumadine; genotype; genes; Warfarin

Additional relevant MeSH terms:

Blood Coagulation Disorders; Hemostatic Disorders; Hematologic Diseases; Vascular Diseases	Cardiovascular Diseases; Hemorrhagic Disorders; Warfarin; Anticoagulants