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:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2025-12-26 @ 11:00 AM
NCT ID:
NCT05732506
Eligibility Criteria:
Inclusion Criteria:
* Patients 75 years of age or older with a diagnosis of NVAF.
* Patients in whom treatment had been started in the 6 months prior to enrollment in the study with Edoxaban for prevention of stroke and systemic embolism after diagnosis of NVAF and according to the drug's technical data sheet.
* Frailty criteria according to the FRAIL scale (score of 3 to 5 points).
* Written informed consent to participate in the study prior to any intervention.
Exclusion Criteria:
* Creatinine clearance according to the CKD-EPI formula less than 15 ml/min/m2
* Moderate or severe hepatic insufficiency (Defined as grade B or C of the Child-Pugh classification.
* Contraindication to receive Edoxaban according to the Technical Data Sheet.
* Participation in any clinical drug trial in the 2 months prior to the initial visit.
* Absence of recorded patient or treatment information.
* Surgical or percutaneous occlusion of the left atrial appendage or intention to perform such intervention at the time of inclusion.
* Any circumstance that, in the opinion of the investigator, affects patient follow-up (including life expectancy of less than two years or inability to perform follow-up).
* Persons who are legally incapacitated or unable to understand informed consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
75 Years
Study:
NCT05732506
Study Brief:
Protocol Section:
NCT05732506