Status:
COMPLETED
A Pharmacogenetic Study of Warfarin Dosing, "The COUMA-GEN Study"
Lead Sponsor:
Intermountain Health Care, Inc.
Collaborating Sponsors:
Deseret Foundation
LDS Hospital Cardiovascular Research
Conditions:
Atrial Fibrillation
Deep Vein Thrombosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Anticoagulation with warfarin is a common and potentially hazardous therapeutic intervention. It is a leading cause of iatrogenic bleeding events and, hence, of malpractice claims. There are no good a...
Detailed Description
The objectives of this study are to determine 1. whether the pharmacogenetic guided arm can maintain patients a greater time in therapeutic range (TTR - percentage of values in the targeted therapeut...
Eligibility Criteria
Inclusion
- The patient (male or non-pregnant/non lactating female1) must be \> 18 years of age.
- The patient or legally authorized representative must sign a written informed consent, prior to the procedure.
- The potentially eligible patient is at high (post-orthopedic surgery) risk of DVT and the treatment plan will include anticoagulation using warfarin with standard of care follow up including INR assessment.
- The potentially eligible patient is diagnosed with DVT or at high (post-orthopedic surgery) risk of DVT and the treatment plan will include anticoagulation using warfarin with standard of care follow up including INR assessment.
- Patient is diagnosed with atrial fibrillation (AF) and the treatment plan will include anticoagulation using warfarin with standard of care follow up including INR assessment.
- Heart failure patients (EF\<25% or apical akinesis or left ventricular aneurysm or extensive wall motion abnormality) in sinus rhythm being started on warfarin to reduce the risk of thromboembolism.
- Women of childbearing potential must be using adequate measures of contraception (as determined by the Investigator) to avoid pregnancy and should be highly unlikely to conceive during the study period.
- Women of childbearing potential must have a negative pregnancy test at screen.
Exclusion
- Pregnant and/or lactating women and women of child bearing potential not using acceptable means of contraception.
- Participation in any other clinical trials involving investigational or marketed products within 30 days prior to entry in the study.
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2007
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00334464
Start Date
February 1 2006
End Date
November 1 2007
Last Update
August 21 2008
Active Locations (1)
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1
LDS Hospital
Salt Lake City, Utah, United States, 84143