Back to resultsClinical and Economic Implications of Genetic Testing for Warfarin Management
Primary Purpose
Blood Coagulation Disorders
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Warfarin
Sponsored by
About this trial
This is an interventional other trial for Blood Coagulation Disorders focused on measuring coumadine, genotype, genes, Warfarin
Eligibility 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
Sites / Locations
- University of Chicago
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Clinically Guided Cohort
Pharmacogenetically Guided Cohort
Arm Description
Estimated Effective Warfarin dosing calculations are based on clinical data algorithms
Estimated Effective Warfarin dosing calculations are based on genetic and clinical data algorithms.
Outcomes
Primary Outcome Measures
Inpatient Length of Stay
Inpatient length of stay
Secondary Outcome Measures
Supratherapeutic Dosing
International Normalized Ratio
Full Information
NCT ID
NCT00964353
First Posted
August 12, 2009
Last Updated
November 6, 2019
Sponsor
University of Chicago
Collaborators
Agency for Healthcare Research and Quality (AHRQ)
1. Study Identification
Unique Protocol Identification Number
NCT00964353
Brief Title
Clinical and Economic Implications of Genetic Testing for Warfarin Management
Official Title
The Hospital and Economics CERT: Project 1: The Clinical and Economic Implications of Genetic Testing for Warfarin Management
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
April 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
Collaborators
Agency for Healthcare Research and Quality (AHRQ)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Coagulation Disorders
Keywords
coumadine, genotype, genes, Warfarin
7. Study Design
Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
359 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Clinically Guided Cohort
Arm Type
Active Comparator
Arm Description
Estimated Effective Warfarin dosing calculations are based on clinical data algorithms
Arm Title
Pharmacogenetically Guided Cohort
Arm Type
Experimental
Arm Description
Estimated Effective Warfarin dosing calculations are based on genetic and clinical data algorithms.
Intervention Type
Drug
Intervention Name(s)
Warfarin
Other Intervention Name(s)
Coumadin
Intervention Description
Dose estimates will be suggested daily for initial dose given and up to 4 consecutive doses after initial dose.
Primary Outcome Measure Information:
Title
Inpatient Length of Stay
Description
Inpatient length of stay
Time Frame
during hospital stay, up to 60 days
Secondary Outcome Measure Information:
Title
Supratherapeutic Dosing
Description
International Normalized Ratio
Time Frame
during hospital stay, up to 60 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David O Meltzer, MD, PhD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Clinical and Economic Implications of Genetic Testing for Warfarin Management
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