Status:
COMPLETED
Genetic Response to Warfarin in Healthy Subjects
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Conditions:
Healthy
Eligibility:
All Genders
18-74 years
Phase:
NA
Brief Summary
The purpose of this study is to determine the importance of genetic differences on individuals' response to warfarin in a group of healthy subjects. Warfarin is also known by the "trade name" Coumadin...
Detailed Description
Warfarin is a highly effective oral anticoagulant that is increasingly prescribed in the United States. It has a narrow therapeutic window, however, that represents an inherent limitation, such that i...
Eligibility Criteria
Inclusion
- Healthy adult (\> 18 years old.) subjects not taking warfarin
- Willing and able to grant written informed consent
- Available in proximity to the Medical Center for the anticipated duration of data collection (approximately 3 weeks).
- Pre-menopausal women required negative pregnancy test at study onset and willingness to abstain from sexual activity or use barrier contraception; oral contraceptives interfere with coumadin.
Exclusion
- Daily prescribed medications including (1) a medication known to interact with warfarin, based on interactions listed in Micromedex as moderate or severe, and probable or definite (as of study start date, Appendix A) (2) aspirin or clopidogrel, which may increase bleeding risk in combination with warfarin.
- Recent therapy (within two weeks) with a medication known to interact with warfarin based on medication interactions listed in Micromedex
- History of thrombotic disorder requiring anticoagulant therapy
- Thrombophilia or coagulopathy, by history or screening coagulation profile with INR or PTT level \> 2x the upper limit of normal
- Family history of thrombophilia or coagulopathy; prisoners or wards of the state; scheduled elective surgery within one month
- Active liver disease based on clinical history or serum transaminase levels \> 2x the upper limit of normal
- Protein C or S Deficiency assessed on screening protein C and S activity profile
- Age ≥ 75
- Pre-menopausal women on oral contraception
- Non-English speaking individuals
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT01520402
Start Date
June 1 2009
End Date
May 1 2011
Last Update
February 12 2013
Active Locations (1)
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1
Mount Sinai School of Medicine
New York, New York, United States, 10029