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 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 12:01 AM
NCT ID:
NCT06052358
Eligibility Criteria:
Inclusion Criteria:
* All male and female patients who are \> 18 years of age
* Have Atrial Fibrillation
* Have CHADS2VASc \> 2
* Have history of GI bleeding OR hospital admission that required blood transfusion OR emergency room visit requiring stopping of OAC OR outpatient 2 gm of Hgb drop from baseline, with or without evidence of upper or lower GI bleeding and requiring endoscopic procedure with holding of OAC.
* Ability to understand study procedures and to comply with them for the entire length of the study.
Exclusion Criteria:
* Inability or unwillingness of individual to give written informed consent.
* Other indications for OAC like deep vein thrombosis (DVT) or Pulmonary embolism (PE) or mechanical heart valve.
* Patient who is pregnant will be excluded (Pregnancy will be excluded by checking urine beta-HCG).
* Patient not following up with our practice / clinic after the procedure
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06052358
Study Brief:
Protocol Section:
NCT06052358