Status:
COMPLETED
Genotype-Guided Warfarin Therapy Trial
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
UNC Institute for Pharmacogenomics and Individualized Therapy
Conditions:
Atrial Fibrillation
Deep Vein Thrombosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of the investigators' study is to determine the clinical utility of a warfarin-dosing algorithm that incorporates genetic information (VKORC1 and CYP2C9 alleles) for adult patients initiat...
Detailed Description
Almost 20 million prescriptions are written for warfarin each year in the US and yet it is one of the most problematic drugs in the modern medical formulary. Warfarin has a narrow therapeutic window a...
Eligibility Criteria
Inclusion
- Adults ≥18 years old
- Patients who are beginning warfarin for a variety of diseases or conditions that require long-term oral anticoagulation with target INR \> 2.0 for at least 3 months
- Subjects that will be following up in UNC anticoagulation clinics at the Ambulatory Care Center or the Family Medicine Center
Exclusion
- Patients who are unable to complete the study materials (questionnaires) with or without assistance (for example, those with dementia)
- Non-English speaking patients
- Patients who are being started on anticoagulation intended to last \< 3 months or whose target INR is \< 2.0
- Patients who have a history of treatment with warfarin and a known dose requirement will be excluded (as they should be restarted on the previous dose)
- Pregnant women will be excluded because warfarin is a teratogen and pregnant women should not take the medication
- Patients will also be excluded if their treating physician does not agree to use the recommended INR dose or feels that the patient should not be enrolled in the study
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
109 Patients enrolled
Trial Details
Trial ID
NCT00904293
Start Date
August 1 2008
End Date
January 1 2012
Last Update
May 6 2016
Active Locations (1)
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1
UNC Hospitals, UNC Anticoagulation Clinic at the Ambulatory Care Center (ACC), UNC Family Medicine Center Anti-coagulation Clinic
Chapel Hill, North Carolina, United States, 27599