Safety Evaluation of Edoxaban in Elderly Patients With Frailty Criteria

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

Study Overview

• Status: Completed
• Conditions: Auricular Fibrillation
• Intervention / Treatment: Drug: 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 Type: Observational
• Enrollment (Actual): 411

Contacts and Locations

Study Locations

• Spain
  • A Coruña, Spain, 15006
    • Complejo Hospitalario Universitario de A Coruña
  • Albacete, Spain, 02006
    • Hospital Universitario Nuestra Señora del Perpétuo Socorro
  • Alicante, Spain, 03314
    • Hospital Vega Baja
  • Badajoz, Spain, 06010
    • Hospital Perpetuo Socorro
  • Barcelona, Spain, 08003
    • Hospital del Mar
  • Cáceres, Spain, 10003
    • Hospital San Pedro de Alcántara
  • Granada, Spain, 18014
    • Hospital Universitario Virgen de Las Nieves
  • León, Spain, 24071
    • Hospital Universitario de Leon
  • Madrid, Spain, 28006
    • Hospital Universitario De La Princesa
  • Málaga, Spain, 29010
    • Hospital Regional Universitario de Malaga
  • Santa Cruz De Tenerife, Spain, 38010
    • Hospital Universitario Nuestra Señora de Candelaria
  • Valencia, Spain, 46010
    • Hospital Clinico Universitario de Valencia
  • Valencia, Spain, 46026
    • Hospital Universitario y Politécnico La Fe
  • Valencia, Spain, 46014
    • Consorcio Hospital General Universitario de Valencia
  • Zaragoza, Spain, 50009
    • Hospital Clínico Universitario Lozano Blesa
  • Zaragoza, Spain, 50009
    • Hospital Universitario Miguel Servet
  • A Coruña
    • Ferrol, A Coruña, Spain, 15405
      • Complejo Hospitalario Universitario de Ferrol
  • Alava
    • Vitoria, Alava, Spain, 01004
      • Hospital Universitario de Araba
  • Alicante
    • Elche, Alicante, Spain, 03293
      • Hospital Universitario del Vinalopó
  • Asturias
    • Oviedo, Asturias, Spain, 33011
      • Hospital Universitario Central de Asturias
    • Oviedo, Asturias, Spain, 33012
      • Hospital Monte Naranco
  • Barcelona
    • Sant Joan Despí, Barcelona, Spain, 08970
      • Hospital de Sant Juan Despí
  • Cantabria
    • Santander, Cantabria, Spain, 39008
      • Hospital Universitario Marqués de Valdecilla
  • Castellón
    • Villa-Real, Castellón, Spain, 12540
      • Hospital Universitario de La Plana
  • Cáceres
    • Plasencia, Cáceres, Spain, 10600
      • Hospital Virgen del Puerto Plasencia
  • Cádiz
    • Puerto Real, Cádiz, Spain, 11510
      • Hospital Universitario Puerto Real
  • Galicia
    • Santiago De Compostela, Galicia, Spain
      • Complejo Hospitalario Universitario de Santiago de Compostela
  • La Rioja
    • Logroño, La Rioja, Spain, 26006
      • Hospital San Pedro
  • Las Palmas
    • Arrecife, Las Palmas, Spain, 35500
      • Hospital Universitario Doctor José Molina Orosa
  • León
    • Ponferrada, León, Spain, 24404
      • Hospital del Bierzo
  • Madrid
    • Getafe, Madrid, Spain, 28905
      • Hospital Universitario de Getafe
    • Majadahonda, Madrid, Spain, 28222
      • Hospital Universitario Puerta de Hierro
    • San Sebastián De Los Reyes, Madrid, Spain, 28702
      • Hospital Infanta Sofía
  • Navarra
    • Pamplona, Navarra, Spain, 31008
      • Hospital Universitario de Navarra
  • Pontevedra
    • Vigo, Pontevedra, Spain, 36214
      • Complejo Hospitalario Universitario de Vigo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 75 years and older (Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The study population will consist of patients ≥75 years diagnosed with NVAF who meet frailty criteria and who have been receiving anticoagulation therapy with Edoxaban for no more than 6 months prior to study inclusion according to AEMPS recommendations and the summary of product characteristics.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients; 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; There are not intervention.; Other Names: Lixiana

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Galaxia Empírica
• Investigators: Principal Investigator: Álvaro Hermida Ameijeiras

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Actual): March 31, 2025
• Study Completion (Actual): April 9, 2025

Study Registration Dates

• First Submitted: February 7, 2023
• First Submitted That Met QC Criteria: February 16, 2023
• First Posted (Actual): February 17, 2023

Study Record Updates

• Last Update Posted (Actual): April 11, 2025
• Last Update Submitted That Met QC Criteria: April 9, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Frailty; Atrial Fibrillation; Molecular Mechanisms of Pharmacological Action; Protease Inhibitors; Enzyme Inhibitors; Anticoagulants; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Edoxaban
• Other Study ID Numbers: EDO-FRAG-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No