Clinical and Economic Implications of Genetic Testing for Warfarin Management

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00964353
First received: August 12, 2009
Last updated: May 22, 2014
Last verified: May 2014

August 12, 2009
May 22, 2014
August 2009
August 2012   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00964353 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Clinical and Economic Implications of Genetic Testing for Warfarin Management
The Hospital and Economics CERT: Project 1: The Clinical and Economic Implications of Genetic Testing for Warfarin Management

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.

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.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Blood Coagulation Disorders
Drug: Warfarin
Dose estimates will be suggested daily for initial dose given and up to 4 consecutive doses after initial dose.
Other Name: Coumadin
  • Active Comparator: Clinically Guided Cohort
    Estimated Effective Warfarin dosing calculations are based on clinical data algorithms
    Intervention: Drug: Warfarin
  • Experimental: Pharmacogenetically Guided Cohort
    Estimated Effective Warfarin dosing calculations are based on genetic and clinical data algorithms.
    Intervention: Drug: Warfarin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
268
December 2014
August 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00964353
16738B
Yes
University of Chicago
University of Chicago
Agency for Healthcare Research and Quality (AHRQ)
Principal Investigator: David O Meltzer, MD, PhD University of Chicago
University of Chicago
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP