Venous Thromboembolism Clinical Trial
Official title:
in Typical Community Practice Settings
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.
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.
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Observational Model: Cohort, Time Perspective: Prospective
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