CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 109 enrolled
Drug / intervention
Genotype-guided dose determination +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00904293
NCT00904293N/ACompleted
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Randomized Controlled Trial of Genotype-Guided Dosing of Warfarin Therapy

University of North Carolina, Chapel Hill·interventional·Posted May 19, 2009·Updated May 6, 2016

In Brief

A clinical study evaluating Genotype-guided dose determination and Non-genotype guided warfarin dosing for Atrial Fibrillation and 3 related conditions. Completed, enrolled 109 participants across 1 site.

Detailed Summary

The purpose of the investigators' study is to determine the clinical utility of a warfarin-dosing algorithm that incorporates genetic information (VKORC1 and CYP2C9 alleles) for adult patients initiating warfarin therapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtrial Fibrillation, Deep Vein Thrombosis, Pulmonary Embolism, Artificial Heart Valve
CountriesUnited States
CollaboratorsUNC Institute for Pharmacogenomics and Individualized Therapy

Timeline

N/ACompletedFinished
2009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 19, 2009
Enrollment StartAug 1, 2008
Primary CompletionJan 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 17.1 years ago

Interventions

Genotype-guided dose determinationother

Patients in both arms will be treated with warfarin. Those in the experimental group will have initial doses determined using an algorithm (from www.warfarindosing.org) incorporating genetic and clinical factors. Those in the control group will have doses determined using the same algorithm, but without including the genetic factors.

Non-genotype guided warfarin dosingother

Those in the control group will have doses determined using the same algorithm, but without including the genetic factors.