Safety Evaluation of Edoxaban in Elderly Patients With Frailty Criteria

Completed

• Conditions: Auricular Fibrillation
• Interventions: Drug: Edoxaban

• Registration Number: NCT05732506
• Lead Sponsor: Galaxia Empírica

Brief Summary

The aim of the present study is to prospectively evaluate the safety of Edoxaban.

Detailed Description

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.

Study Timeline

• Study Start: 2023-02-01
• Study First Submitted: 2023-02-07
• Study First Submitted QC: 2023-02-16
• Study First Posted: 2023-02-17
• Primary Completion: 2025-03-31
• Status Verified: 2025-04
• Study Completion: 2025-04-09
• Last Update Submitted: 2025-04-09
• Last Update Posted: 2025-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 411

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients	Edoxaban	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.

Primary Outcome Measures

Name	Time	Method
Major bleeding.	12 months	Proportion of patients who had a major bleeding during the 12 months of follow-up.

Secondary Outcome Measures

Name	Time	Method
Stroke or systemic embolism.	12 months	Proportion of patients who suffered stroke or systemic embolism during the 12 months of follow-up.

Trial Locations

Locations (35)

Hospital San Pedro; 🇪🇸 Logroño, La Rioja, Spain

Hospital Universitario Doctor José Molina Orosa; 🇪🇸 Arrecife, Las Palmas, Spain

Hospital del Bierzo; 🇪🇸 Ponferrada, León, Spain

Hospital Universitario de Getafe; 🇪🇸 Getafe, Madrid, Spain

Hospital Universitario Puerta De Hierro; 🇪🇸 Majadahonda, Madrid, Spain

Complejo Hospitalario Universitario de Ferrol; 🇪🇸 Ferrol, A Coruña, Spain

Hospital Universitario de Áraba; 🇪🇸 Vitoria, Alava, Spain

Hospital Universitario del Vinalopó; 🇪🇸 Elche, Alicante, Spain

Hospital Universitario Central de Asturias; 🇪🇸 Oviedo, Asturias, Spain

Hospital Monte Naranco; 🇪🇸 Oviedo, Asturias, Spain

Hospital de Sant Juan Despí; 🇪🇸 Sant Joan Despí, Barcelona, Spain

Hospital Universitario Marqués de Valdecilla; 🇪🇸 Santander, Cantabria, Spain

Hospital Universitario de La Plana; 🇪🇸 Villa-Real, Castellón, Spain

Hospital Virgen del Puerto Plasencia; 🇪🇸 Plasencia, Cáceres, Spain

Hospital Universitario Puerto Real; 🇪🇸 Puerto Real, Cádiz, Spain

Complejo Hospitalario Universitario de Santiago de Compostela; 🇪🇸 Santiago De Compostela, Galicia, Spain

Hospital Infanta Sofia; 🇪🇸 San Sebastián De Los Reyes, Madrid, Spain

Hospital Universitario de Navarra; 🇪🇸 Pamplona, Navarra, Spain

Complejo Hospitalario Universitario de Vigo; 🇪🇸 Vigo, Pontevedra, Spain

Complejo Hospitalario Universitario de A Coruña; 🇪🇸 A Coruña, Spain

Hospital Universitario Nuestra Señora del Perpetuo Socorro; 🇪🇸 Albacete, Spain

Hospital Vega Baja; 🇪🇸 Alicante, Spain

Hospital Perpetuo Socorro; 🇪🇸 Badajoz, Spain

Hospital del Mar; 🇪🇸 Barcelona, Spain

Hospital San Pedro de Alcántara; 🇪🇸 Cáceres, Spain

Hospital Universitario Virgen de las Nieves; 🇪🇸 Granada, Spain

Hospital Universitario de León; 🇪🇸 León, Spain

Hospital Universitario de La Princesa; 🇪🇸 Madrid, Spain

Hospital Regional Universitario de Málaga; 🇪🇸 Málaga, Spain

Hospital Universitario Nuestra Señora de Candelaria; 🇪🇸 Santa Cruz De Tenerife, Spain

Hospital Clínico Universitario de Valencia; 🇪🇸 Valencia, Spain

Consorcio Hospital General Universitario de Valencia; 🇪🇸 Valencia, Spain

Hospital Universitario y Politécnico La Fe; 🇪🇸 Valencia, Spain

Hospital Clínico Universitario Lozano Blesa; 🇪🇸 Zaragoza, Spain

Hospital Universitario Miguel Servet; 🇪🇸 Zaragoza, Spain