Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2025-12-25 @ 3:48 AM
NCT ID:
NCT01520402
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
74 Years
Study:
NCT01520402
Study Brief:
Protocol Section:
NCT01520402