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 @ 11:50 AM
Ignite Modification Date:
2025-12-24 @ 11:50 AM
NCT ID:
NCT03911661
Eligibility Criteria:
Inclusion Criteria:
* Patients at least 22 years of age treated with warfarin for any indication for at least 18 months prior to enrollment within University of Utah Health system.
* Demonstrates the willingness and ability to test their own INR using a point-of-care INR monitoring device, and willingness to make independent decisions about warfarin dosing based on INR results using a dosing algorithm.
* Willingness to perform INR tests at least once weekly or more frequently as the algorithm dictates.
* Currently have and willing to maintain internet access for the duration of the study in order to complete online case report forms.
* Individual TTR \< 60% over the 12 months prior to study enrollment.
Exclusion Criteria:
* Inherent INR variability \>0.4 (such patients are unlikely to benefit from the Fearon Algorithm).
* Goal INR range less than a full INR point (e.g. 2.0-2.5).
* Known poor compliance to warfarin therapy (e.g., failure to take warfarin as instructed clearly documented in electronic medical record and/or return for INR testing as evidenced by repeated reminder communications documented in electronic medical record).
* More than one interruption of warfarin therapy for invasive procedure(s) lasting more than three days in the 18 months prior to study enrollment.
* Non-English speaking.
* Refusal to provide written informed consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
22 Years
Study:
NCT03911661
Study Brief:
Protocol Section:
NCT03911661