The Clinical and Economic Impact of Pharmacogenomic Testing of Warfarin Therapy in Typical Community Practice Settings
Information source: Medco Health Solutions, Inc.
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Embolism and Thrombosis; Embolism; Vascular Diseases; Warfarin; Venous Thromboembolism; Thrombosis; Thromboembolism
Intervention: CYP 2C9 and VKORC1 Testing for Warfarin (Other)
Phase: N/A
Status: Recruiting
Sponsored by: Medco Health Solutions, Inc.
Summary
The purpose of this 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.
Clinical Details
Official title: in Typical Community Practice Settings
Study design: Case Control, Prospective
Primary outcome: Time to stable warfarin dose
Secondary outcome: Number of clots or bleeds for testing patients vs. non-tested patients
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 P450 system, the cytochrome P450 2C9 (CYP 2C9) isoenzyme specifically, and
polymorphisms in the CYP 2C9 gene have been associated with changes in metabolic function of
the translated isoenzyme . These polymorphisms result in reduced metabolism of warfarin as
compared to subjects having the wild type gene, consequently leading to systemic accumulation
of warfarin; it is theorized that this leads to higher risk of adverse events. Other allelic
variations have also been linked to changes in vitamin K conservation through their effects
on vitamin K epoxide reductase complex, subunit 1 (VKORC1) . The combined impact of CYP 2C9
and VKORC1 polymorphisms on warfarin's pharmacology have recently been reported.
It is hypothesized that evaluation of genomic allelic type guided warfarin dosing will reduce
thromboembolic and bleeding risks associated with warfarin therapy, and that adoption of a
genetic testing strategy in a primary patient care setting would improve warfarin
effectiveness and patient safety, and reduce costs to health care payers.
Eligibility
Minimum age: 40 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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
Locations and Contacts
Medco Health Solutions, Inc., Franklin Lakes, New Jersey 07003, United States; Recruiting
Teresa DeLuca, MD, Phone: 201-269-5042, Email: teresa_deluca@medco.com
Jeff Vernice, PhD, Phone: 201-269-6645, Email: jeff_vernice@medco.com
Teresa DeLuca, MD, Principal Investigator
Thomas P. Moyer, PhD, Sub-Investigator
Dennis J. O'Kane, PhD, Sub-Investigator
Dennis M. Manning, MD, Sub-Investigator
Robert D. McBane, MD, Sub-Investigator
J. Russell Teagarden, MS, RPh, Sub-Investigator
Robert S. Epstein, MS, MD, Sub-Investigator
Ronald E. Aubert, PhD, Sub-Investigator
Brian F. Gage, MD, Sub-Investigator
Jeff Vernice, PhD, Sub-Investigator
Additional Information
Starting date: July 2007
Ending date: July 2009
Last updated: January 30, 2009
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