Overview

This trial is active, not recruiting.

Condition blood coagulation disorders
Treatment warfarin
Phase phase 4
Sponsor University of Chicago
Collaborator Agency for Healthcare Research and Quality (AHRQ)
Start date August 2009
End date August 2012
Trial size 268 participants
Trial identifier NCT00964353, 16738B

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Arm
(Active Comparator)
Estimated Effective Warfarin dosing calculations are based on clinical data algorithms
warfarin Coumadin
Dose estimates will be suggested daily for initial dose given and up to 4 consecutive doses after initial dose.
(Experimental)
Estimated Effective Warfarin dosing calculations are based on genetic and clinical data algorithms.
warfarin Coumadin
Dose estimates will be suggested daily for initial dose given and up to 4 consecutive doses after initial dose.

Primary Outcomes

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

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title The Hospital and Economics CERT: Project 1: The Clinical and Economic Implications of Genetic Testing for Warfarin Management
Principal investigator David O Meltzer, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University of Chicago.