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Comparison of Warfarin Dosing Using Decision Model Versus Pharmacogenetic Algorithm

NCT ID: NCT00511173

Last Updated: 2012-12-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2008-11-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Atrial Fibrillation Pulmonary Embolism Deep Vein Thrombosis

Keywords

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mechanical valve

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Clinician dosing of warfarin

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

Group Type EXPERIMENTAL

Warfarin Dose based on pharmacogenetics

Intervention Type GENETIC

Warfarin dose adjustment will be based on the standard clinician dosing compared to the use of the pharmacogenetic base algorithm

Interventions

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Warfarin Dose based on pharmacogenetics

Warfarin dose adjustment will be based on the standard clinician dosing compared to the use of the pharmacogenetic base algorithm

Intervention Type GENETIC

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Creighton University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christopher J. Destache, Pharm. D.

Role: PRINCIPAL_INVESTIGATOR

Creighton University

Countries

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United States

Other Identifiers

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06-14171

Identifier Type: -

Identifier Source: org_study_id