Clinical and Economic Implications of Genetic Testing for Warfarin Management
|
Status:
This study is currently recruiting participants.
Purpose:
To explore how knowing genes that individuals inherit from their parents can make warfarin dosing more safe and effective.
Interventions:
Warfarin
Anticoagulant (Vitamin K antagonist)
|
Year Started:
2009
Design:
Interventional, Randomized, Open Label, Dose Comparison, Parallel Assignment.
Inclusion Criteria
Warfarin-naive patients; 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.
Patient Involvement:
Patients will be randomized to one of two arms: 1) Clinically Guided Cohort: where Estimated Effective Warfarin dosing calculations are based on clinical data algorithms and 2) Pharmacogenetically Guided Cohort: Experimental where
Estimated Effective Warfarin dosing calculations are based on genetic and clinical data algorithms. In both arms, Warfarin Dose estimates will be suggested daily for initial dose given and up to 4 consecutive doses after initial dose. Patient will be evaluated for outcomes at 30 days and followed for 1 year.
Primary Outcome:
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.
Secondary Outcome:
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); direct costs of interest include: hospital costs, genetic costs, medication costs, laboratory costs, and total therapy costs in aggregate and broken down by payer.
|
Source of Information:
ClinicalTrials.gov
|
Web Links and Publications:
|
|
This information last updated on: 9/15/2009
Reviewed on: 09/15/2009.
|
Trials
Directories