Safety Evaluation of Edoxaban in Elderly Patients With Frailty Criteria

Study Overview
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Brief Summary
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The aim of the present study is to prospectively evaluate the safety of Edoxaban.

Detailed Description
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The aim of the present study is to prospectively evaluate the safety of Edoxaban in daily clinical practice in Spain in elderly patients with nonvalvular atrial fibrillation who meet the criteria for frailty and who have been prescribed the drug recently (<6 months prior to inclusion). The study will provide us with a clear and real-life picture of bleeding and ischemic complications and possible treatment interruptions with Edoxaban in real life and in a large subgroup, although underrepresented in the studies.

Official Title
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Safety Evaluation of Edoxaban in Elderly Patients With Frailty Criteria

Conditions
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Auricular Fibrillation

Intervention / Treatment
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* Drug: Edoxaban


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients<br>Elderly patients diagnosed with nonvalvular atrial fibrillation who meet the frailty criteria and who had been receiving anticoagulant treatment with Edoxaban for no more than 6 months prior to inclusion in the study. | Drug: Edoxaban<br>* There are not intervention.<br>* Other names: Lixiana;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major bleeding. | Proportion of patients who had a major bleeding during the 12 months of follow-up. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stroke or systemic embolism. | Proportion of patients who suffered stroke or systemic embolism during the 12 months of follow-up. | 12 months |