NCT00377143

Brief Summary

Warfarin (also called Coumadin®) is an anticoagulant drug (blood thinner) given to patients to help prevent blood clots from forming or to help prevent the growth of an existing blood clot. The purpose of this study is to collect information on a possible method used to determine the best warfarin dose for people before they start warfarin. This study will focus on finding out if a person's stable dose can be better predicted by using a new approach (called "pharmacogenetic-guided dosing") compared to the current warfarin dosing method. The pharmacogenetic-guided dosing method (the new warfarin dosing method) will use a person's specific health and genetic information to calculate a patient's warfarin dose at the beginning of warfarin treatment. The hope is that through this research, we may someday be able to use an individual's genetic information to guide the selection of their specific warfarin dose at the beginning of treatment, leading to precise warfarin dosing and less need for the current trial and error process.

Trial Health

35
At Risk

Trial Health Score

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

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 13, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2006

Completed
Last Updated

February 16, 2012

Status Verified

September 1, 2011

Enrollment Period

1 month

First QC Date

September 13, 2006

Last Update Submit

February 14, 2012

Conditions

Blood Coagulation Disorders

Keywords

warfarinpharmacogenomicCYP2C9VKORC1polymorphism, single nucleotide

Outcome Measures

Primary Outcomes (1)

  • Accuracy of the initial versus the stable warfarin dose, measured as mean absolute difference in initial versus stable dose

Secondary Outcomes (3)

  • Time to stable dose

  • The frequency of subtherapeutic and supratherapeutic international normalized ratio (INR) measurements

  • The fraction of population overdosed and underdosed at warfarin initiation

Interventions

Warfarin DosingDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Newly initiating warfarin

You may not qualify if:

  • Previous use of warfarin
  • Cancer
  • Hepatic Disease
  • History of alcoholism
  • Diarrheal illness
  • Febrile Illness
  • Blood dyscrasias
  • Pregnancy
  • Medical plan to hold warfarin administration before stable dose is achieved (ie. for surgical intervention)
  • Dementia
  • Active bleed
  • Aneurysm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shands at the University of Florida

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Blood Coagulation DisordersVitamin K-Dependent Clotting Factors, Combined Deficiency Of, Type 2

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Julie A Johnson, Pharm.D.

    University of Florida

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2006

First Posted

September 15, 2006

Study Start

July 1, 2006

Primary Completion

August 1, 2006

Last Updated

February 16, 2012

Record last verified: 2011-09

Locations

US(1)