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:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2025-12-24 @ 9:07 PM
NCT ID:
NCT02392104
Eligibility Criteria:
Inclusion Criteria:
* 18 years of age or older
* requirement for indefinite warfarin therapy
* target INR of 2-3
* stable weekly warfarin dose for the past 6 months (not more than a single, one-time adjustment (boost/omission) in the past 6 months, planned interruption for a procedure or surgery with INR(s) out of range in the past 6 months would not exclude a patient)
* a patient of the Madison VA anticoagulation clinic for the previous 12 months
Exclusion Criteria:
* consistently drink ≥4 alcoholic beverages/day or a documented episode of alcohol binging in the past 6 months
* diagnosis of cancer and on active chemotherapy/radiotherapy in the past 3 months
* life expectancy of \< 1 year
* enrolled in other investigational drug protocols
* only receiving anticoagulation care at the Madison VA for part of the year (e.g. snowbirds)
* receiving visiting nurse services for INR monitoring
* thrombocytopenia (\<100K) within past 12 months
* history of bleeding or thromboembolism requiring medical intervention within past 6 months
* treatment for active liver disease (e.g. hepatitis)
* diagnosis or documentation in EMR suggesting cognitive impairment
* activated power of attorney
* inability to provide informed consent
* non-English speaking
* unstable mental health disorder that impairs judgment
* history of non-adherence to anticoagulation clinic policies and procedures (i.e. missed appointments, self-adjustment of warfarin dose, nonadherence, etc.).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02392104
Study Brief:
Protocol Section:
NCT02392104