Status:
COMPLETED
Applying Pharmacogenetic Algorithms to Individualize Dosing of Warfarin
Lead Sponsor:
Intermountain Health Care, Inc.
Conditions:
Thromboembolism
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this study is to determine whether DNA analysis improves the efficiency of dosing and safety in patients who are being started on warfarin therapy.Warfarin, a blood thinner (anticoagula...
Detailed Description
Study Objectives: The specific objectives of CoumaGen-II to be tested are: 1. To apply routine pharmacogenetic (PG)-guided dosing of warfarin in clinical practice at Intermountain Healthcare facilit...
Eligibility Criteria
Inclusion
- New participants will be those \>=18 years old who are appropriate candidates for and being initiated on warfarin therapy with target international normalized prothrombin time ratio (INR) range of either 2-3 or 2.5-3.5 and with intent to be treated for at least 1 month and willing to sign informed consent.
- Those with target INR 2.5-3.5 may be enrolled with dose adjustment for this higher target per Gage et-al. (i.e., 11% increase in dose).
- Dose modification also will be made for amiodarone based on prior, published experience (i.e., 22% decrease in dose).
Exclusion
- Those not appropriate for warfarin (e.g., pregnancy) or for pharmacogenetic (PG)-guided dosing for any reason,
- Those having received rifampin within 3 weeks,
- Those with severe co-morbidities (e.g., creatinine \> 2.5,hepatic insufficiency, active malignancy, advanced physiological age, noncompliance risk, expected survival \<6 months), and
- Physician or patient preference.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
2415 Patients enrolled
Trial Details
Trial ID
NCT00927862
Start Date
August 1 2008
End Date
June 1 2011
Last Update
September 25 2012
Active Locations (1)
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1
Intermountain Healthcare Hospitals and Clinics
Salt Lake City, Utah, United States, 84107