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Comparison of Warfarin Dosing Using Decision Model Versus Pharmacogenetic Algorithm

Primary Purpose

Atrial Fibrillation, Pulmonary Embolism, Deep Vein Thrombosis

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Warfarin Dose based on pharmacogenetics
Sponsored by
Creighton University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Atrial Fibrillation focused on measuring mechanical valve

Eligibility Criteria

19 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Clinician dosing of warfarin

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    In Patients Receiving Warfarin, a Pharmacogenetic Algorithm Dose Was Compared to Clinician Dosing (mg/wk).
    Warfarin pharmacogenetic algorithm dosing (mg/wk) was compared to clinician warfarin dosing (mg/wk).

    Secondary Outcome Measures

    Full Information

    First Posted
    August 1, 2007
    Last Updated
    December 7, 2012
    Sponsor
    Creighton University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00511173
    Brief Title
    Comparison of Warfarin Dosing Using Decision Model Versus Pharmacogenetic Algorithm
    Official Title
    Warfarin Dosing: Pharmacogenetic Algorithm Compared to Pharmacist's Dosing
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2006 (undefined)
    Primary Completion Date
    November 2008 (Actual)
    Study Completion Date
    November 2008 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Creighton University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Atrial Fibrillation, Pulmonary Embolism, Deep Vein Thrombosis
    Keywords
    mechanical valve

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    102 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Clinician dosing of warfarin
    Arm Type
    Experimental
    Arm Description
    Warfarin dose based on clinician dosing without the use of warfarin pharmacogenetics
    Intervention Type
    Genetic
    Intervention Name(s)
    Warfarin Dose based on pharmacogenetics
    Intervention Description
    Warfarin dose adjustment will be based on the standard clinician dosing compared to the use of the pharmacogenetic base algorithm
    Primary Outcome Measure Information:
    Title
    In Patients Receiving Warfarin, a Pharmacogenetic Algorithm Dose Was Compared to Clinician Dosing (mg/wk).
    Description
    Warfarin pharmacogenetic algorithm dosing (mg/wk) was compared to clinician warfarin dosing (mg/wk).
    Time Frame
    six months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Christopher J. Destache, Pharm. D.
    Organizational Affiliation
    Creighton University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Comparison of Warfarin Dosing Using Decision Model Versus Pharmacogenetic Algorithm

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