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Comparison of Warfarin Dosing Using Decision Model Versus Pharmacogenetic Algorithm

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ClinicalTrials.gov Identifier: NCT00511173
Recruitment Status : Completed
First Posted : August 3, 2007
Results First Posted : December 11, 2012
Last Update Posted : December 11, 2012
Sponsor:
Information provided by (Responsible Party):
Creighton University

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

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

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
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
Study Start Date : August 2006
Primary Completion Date : November 2008
Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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).



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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

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

Responsible Party: Creighton University
ClinicalTrials.gov Identifier: NCT00511173     History of Changes
Other Study ID Numbers: 06-14171
First Posted: August 3, 2007    Key Record Dates
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