NCT00511173

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P25-P50 for phase_4 atrial-fibrillation

Timeline
Completed

Started Aug 2006

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

August 1, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 3, 2007

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
4.1 years until next milestone

Results Posted

Study results publicly available

December 11, 2012

Completed
Last Updated

December 11, 2012

Status Verified

December 1, 2012

Enrollment Period

2.3 years

First QC Date

August 1, 2007

Results QC Date

April 17, 2012

Last Update Submit

December 7, 2012

Conditions

Atrial FibrillationPulmonary EmbolismDeep Vein Thrombosis

Keywords

mechanical valve

Outcome Measures

Primary Outcomes (1)

  • 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).

    six months

Study Arms (1)

Clinician dosing of warfarin

EXPERIMENTAL

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

Genetic: Warfarin Dose based on pharmacogenetics

Interventions

Warfarin Dose based on pharmacogeneticsGENETIC

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

Clinician dosing of warfarin

Eligibility Criteria

Age19 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed patients with atrial fibrillation, deep venous thrombosis, or pulmonary embolism requiring warfarin therapy

You may not qualify if:

  • Patients with atrial fibrillation, deep venous thrombosis, or pullmonary embolism requiring warfarin therapy who do not consent to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Atrial FibrillationPulmonary EmbolismVenous Thrombosis

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsLung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesThrombosis

Results Point of Contact

Title
Christopher Destache
Organization
Creighton University
destache@creighton.edu
402-280-4744

Study Officials

  • Christopher J. Destache, Pharm. D.

    Creighton University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2007

First Posted

August 3, 2007

Study Start

August 1, 2006

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

December 11, 2012

Results First Posted

December 11, 2012

Record last verified: 2012-12