Comparison of Warfarin Dosing Using Decision Model Versus Pharmacogenetic Algorithm

Creighton University

Status and phase: Completed; Phase 4

Conditions: Pulmonary Embolism; Atrial Fibrillation; Deep Vein Thrombosis

Treatments: Genetic: Warfarin Dose based on pharmacogenetics

Study type: Interventional

Funder types: Other

Identifiers

NCT00511173

06-14171

Details and patient eligibility

About

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

Full 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.

Enrollment: 102 patients

Sex: All

Ages: 19 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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102 participants in 1 patient group

Clinician dosing of warfarin

Experimental group

Description:

Warfarin dose based on clinician dosing without the use of warfarin pharmacogenetics

Treatment:

Genetic: Warfarin Dose based on pharmacogenetics