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Comparison of Warfarin Dosing Using Decision Model Versus Pharmacogenetic Algorithm

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Creighton University
ClinicalTrials.gov Identifier:
NCT00511173
First received: August 1, 2007
Last updated: December 7, 2012
Last verified: December 2012
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Warfarin Dosing: Pharmacogenetic Algorithm Compared to Pharmacist's Dosing

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   19 Years to 90 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00511173

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

No publications provided

Responsible Party: Creighton University
ClinicalTrials.gov Identifier: NCT00511173     History of Changes
Other Study ID Numbers: 06-14171
Study First Received: August 1, 2007
Results First Received: April 17, 2012
Last Updated: December 7, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Creighton University:
mechanical valve

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

ClinicalTrials.gov processed this record on May 16, 2013