Ignite Creation Date:
2024-05-05 @ 9:13 PM
Last Modification Date:
2024-10-26 @ 10:00 AM
Study NCT ID:
NCT00830570
Status:
COMPLETED
Last Update Posted:
2010-11-16
First Post:
2009-01-26
Brief Title:
The Clinical and Economic Impact of Pharmacogenomic Testing of Warfarin Therapy in Typical Community Practice Settings
Sponsor:
Medco Health Solutions Inc
Organization:
Medco Health Solutions Inc
Study Overview
Official Title:
in Typical Community Practice Settings
Status:
COMPLETED
Status Verified Date:
2010-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MHSMayoWarf1
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 epoxide reductase complex subunit 1 VKORC1 testing within a primary patient care setting
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 warfarins 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None