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Comparison of Warfarin Dosing Using Decision Model Versus Pharmacogenetic Algorithm

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00511173
First Posted: August 3, 2007
Last Update Posted: December 11, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Creighton University
  Purpose
This is a prospective comparison of clinician dosing and a pharmacogenetic algorithm in diagnosed patients requiring warfarin therapy.

Condition Intervention Phase
Atrial Fibrillation Pulmonary Embolism Deep Vein Thrombosis Genetic: Warfarin Dose based on pharmacogenetics Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Warfarin Dosing: Pharmacogenetic Algorithm Compared to Pharmacist's Dosing

Resource links provided by NLM:


Further study details as provided by Creighton University:

Primary Outcome Measures:
  • In Patients Receiving Warfarin, a Pharmacogenetic Algorithm Dose Was Compared to Clinician Dosing (mg/wk). [ Time Frame: six months ]
    Warfarin pharmacogenetic algorithm dosing (mg/wk) was compared to clinician warfarin dosing (mg/wk).


Enrollment: 102
Study Start Date: August 2006
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Clinician dosing of warfarin
Warfarin dose based on clinician dosing without the use of warfarin pharmacogenetics
Genetic: 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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00511173


Sponsors and Collaborators
Creighton University
Investigators
Principal Investigator: Christopher J. Destache, Pharm. D. Creighton University
  More Information

Responsible Party: Creighton University
ClinicalTrials.gov Identifier: NCT00511173     History of Changes
Other Study ID Numbers: 06-14171
First Submitted: August 1, 2007
First Posted: August 3, 2007
Results First Submitted: April 17, 2012
Results First Posted: December 11, 2012
Last Update Posted: December 11, 2012
Last Verified: December 2012

Keywords provided by Creighton University:
mechanical valve

Additional relevant MeSH terms:
Atrial Fibrillation
Thrombosis
Embolism
Pulmonary Embolism
Venous Thrombosis
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Lung Diseases
Respiratory Tract Diseases
Warfarin
Anticoagulants