Status:
COMPLETED
The Clinical and Economic Impact of Pharmacogenomic Testing of Warfarin Therapy in Typical Community Practice Settings
Lead Sponsor:
Medco Health Solutions, Inc.
Collaborating Sponsors:
Mayo Clinic
Washington University School of Medicine
Conditions:
Embolism and Thrombosis
Embolism
Eligibility:
All Genders
40-75 years
Brief Summary
The purpose of this quasi-experiment study, which could also be classified as a prospective observational intervention study, is to assess the impact of cytochrome P450 2C9 (CYP 2C9) and vitamin K epo...
Detailed Description
Anticoagulation therapy with warfarin is the most common mode of treatment and prophylaxis for venous and arterial thromboembolic conditions. Warfarin is metabolized in the liver by the cytochrome P45...
Eligibility Criteria
Inclusion
- Female and male age range of 40-75
- Patients who are in the induction phase of warfarin
- Patients receiving warfarin to prevent or treat thromboembolic conditions (e.g., post orthopedic surgery prophylaxis, deep venous thrombosis, atrial fibrillation, pulmonary embolism, heart failure)
- Patient willing to provide informed consent prior to the specimen collection procedure
- Patient whose physician is willing to order the genetic test
Exclusion
- Age \< 40 or \> 75
- Previous use of warfarin within 180 days of initiating new warfarin therapy
- Hospitalized for seven or more days before first claim for warfarin
- Previous history of genetic testing for warfarin therapy
- Known hypersensitivity to warfarin
- Patient or physician refusal to participate in the study
- Patients using warfarin residing in Olmsted County, MN
Key Trial Info
Start Date :
July 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
1635 Patients enrolled
Trial Details
Trial ID
NCT00830570
Start Date
July 1 2007
End Date
January 1 2010
Last Update
November 16 2010
Active Locations (1)
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1
Medco Health Solutions, Inc.
Franklin Lakes, New Jersey, United States, 07003