Comparison of Warfarin Dosing Using Decision Model Versus Pharmacogenetic Algorithm

Phase 4

Completed

• Conditions: Atrial Fibrillation; Pulmonary Embolism; Deep Vein Thrombosis
• Interventions: Genetic: Warfarin Dose based on pharmacogenetics

• Registration Number: NCT00511173
• Lead Sponsor: Creighton University

Brief Summary

This is a prospective comparison of clinician dosing and a pharmacogenetic algorithm in diagnosed patients requiring warfarin therapy.

Detailed Description

Diagnosed patients with atrial fibrillation, pulmonary embolism, or deep venous thrombosis requiring warfarin therapy will be consented and a tube of blood for DNA analysis will be drawn. The clinician dosing group will not be eligible to obtain the pharmacogenetic results and the algorithm group will have their warfarin pharmacogenetic SNPs performed and integrated into the algorithm and the warfarin dose will be calculated. Outcomes of patients receiving both methods will be gathered and statistically analyzed.

Study Timeline

• Study Start: 2006-08
• Study First Submitted: 2007-08-01
• Study First Submitted QC: 2007-08-02
• Study First Posted: 2007-08-03
• Primary Completion: 2008-11
• Study Completion: 2008-11
• Results First Submitted: 2012-04-17
• Status Verified: 2012-12
• Results First Submitted QC: 2012-12-07
• Last Update Submitted: 2012-12-07
• Results First Posted: 2012-12-11
• Last Update Posted: 2012-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

• Diagnosed patients with atrial fibrillation, deep venous thrombosis, or pulmonary embolism requiring warfarin therapy

Exclusion Criteria

• Patients with atrial fibrillation, deep venous thrombosis, or pullmonary embolism requiring warfarin therapy who do not consent to participate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Clinician dosing of warfarin	Warfarin Dose based on pharmacogenetics	Warfarin dose based on clinician dosing without the use of warfarin pharmacogenetics

Primary Outcome Measures

Name	Time	Method
In Patients Receiving Warfarin, a Pharmacogenetic Algorithm Dose Was Compared to Clinician Dosing (mg/wk).	six months	Warfarin pharmacogenetic algorithm dosing (mg/wk) was compared to clinician warfarin dosing (mg/wk).