The Clinical and Economic Impact of Pharmacogenomic Testing of Warfarin Therapy in Typical Community Practice Settings

Completed

Conditions studied: Embolism and Thrombosis, Embolism, Vascular Diseases, Warfarin, Venous Thromboembolism, Thrombosis, Thromboembolism

In brief

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 epoxide reductase complex, subunit 1 (VKORC1) testing within a primary patient care setting.

Key facts

Study ID: NCT00830570
Run by: Medco Health Solutions, Inc.
People needed: 1635
Starts: 2007-07-01
Expected to finish: 2010-01-01
Last updated by the study team: 2010-11-16

Who can join

Age: 40 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Medco Health Solutions, Inc. — Franklin Lakes, New Jersey, United States
Medco Health Solutions, Inc. — Franklin Lakes, New Jersey, United States

Full record on ClinicalTrials.gov

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