Clinical and Economic Implications of Genetic Testing for Warfarin Management
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ClinicalTrials.gov Identifier: NCT00964353 |
Recruitment Status
:
Active, not recruiting
First Posted
: August 24, 2009
Last Update Posted
: January 25, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Blood Coagulation Disorders | Drug: Warfarin | Phase 4 |
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 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 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Clinically Guided Cohort
Estimated Effective Warfarin dosing calculations are based on clinical data algorithms
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Drug: Warfarin
Dose estimates will be suggested daily for initial dose given and up to 4 consecutive doses after initial dose.
Other Name: Coumadin
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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
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- 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 ]
- 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 ]
- 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 ]

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00964353
United States, Illinois | |
University of Chicago | |
Chicago, Illinois, United States, 60637 |
Principal Investigator: | David O Meltzer, MD, PhD | University of Chicago |
Responsible Party: | University of Chicago |
ClinicalTrials.gov Identifier: | NCT00964353 History of Changes |
Other Study ID Numbers: |
16738B |
First Posted: | August 24, 2009 Key Record Dates |
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 |