Venous Thromboembolism Clinical Trial
— MHSMayoWarf1Official title:
in Typical Community Practice Settings
Verified date | November 2010 |
Source | Medco Health Solutions, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
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.
Status | Completed |
Enrollment | 1635 |
Est. completion date | January 2010 |
Est. primary completion date | January 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years to 75 Years |
Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Medco Health Solutions, Inc. | Franklin Lakes | New Jersey |
Lead Sponsor | Collaborator |
---|---|
Medco Health Solutions, Inc. | Mayo Clinic, Washington University School of Medicine |
United States,
Epstein RS, Moyer TP, Aubert RE, O Kane DJ, Xia F, Verbrugge RR, Gage BF, Teagarden JR. Warfarin genotyping reduces hospitalization rates results from the MM-WES (Medco-Mayo Warfarin Effectiveness study). J Am Coll Cardiol. 2010 Jun 22;55(25):2804-12. doi — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary objective of the study is to determine whether the addition of genotyping to usual care will reduce the hospitalization rates for hemorrhage or thromboembolism related to warfarin use during the first 6 months of treatment. | 6 months | No | |
Secondary | The secondary objective is to determine physician and patient acceptance of the technology. | 6 months | No |
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