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: Recruiting
• 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 (Anticipated): 456

Contacts and Locations

• Study Contact: Name: Antonio Domingo Pose Reino; Phone Number: +34 605680912; Email: antonio.pose@usc.es
• Study Contact Backup: Name: Álvaro Hermida Ameijeiras; Phone Number: +34 605680912; Email: alvaro.hermida@usc.es

Study Locations

• Spain
  • A Coruña, Spain, 15006
    • Recruiting
    • Complejo Hospitalario Universitario de A Coruña
    • Contact: Santiago Freire, MD
  • Albacete, Spain, 02006
    • Recruiting
    • Hospital Universitario Nuestra Señora del Perpetuo Socorro
    • Contact: Pedro Abizanda, MD
  • Alicante, Spain, 03314
    • Recruiting
    • Hospital Vega Baja
    • Contact: Jose María Cepeda, MD
  • Badajoz, Spain, 06010
    • Recruiting
    • Hospital Perpetuo Socorro
    • Contact: Jose María Ramiro, MD
  • Barcelona, Spain, 08003
    • Recruiting
    • Hospital del Mar
    • Contact: Cristina Roqueta, MD
  • Cáceres, Spain, 10003
    • Recruiting
    • Hospital San Pedro de Alcántara
    • Contact: Jose Luis González, MD
  • Granada, Spain, 18014
    • Recruiting
    • Hospital Universitario Virgen de las Nieves
    • Contact: Juan Diego Mediavilla, MD
  • León, Spain, 24071
    • Recruiting
    • Hospital Universitario de León
    • Contact: Encarnación Martín, MD
  • Madrid, Spain, 28006
    • Recruiting
    • Hospital Universitario de la Princesa
    • Contact: Alejandra Gullón, MD
  • Málaga, Spain, 29010
    • Recruiting
    • Hospital Regional Universitario de Málaga
    • Contact: Ricardo Gómez, MD
  • Santa Cruz De Tenerife, Spain, 38010
    • Recruiting
    • Hospital Universitario Nuestra Señora de Candelaria
    • Contact: Alicia Tejera, MD
  • Valencia, Spain, 46010
    • Not yet recruiting
    • Hospital Clínico Universitario de Valencia
    • Contact: María Jose Forner, MD
  • Valencia, Spain, 46026
    • Recruiting
    • Hospital Universitario y Politécnico La Fe
    • Contact: Jon Ortiz, MD
  • Valencia, Spain, 46014
    • Not yet recruiting
    • Consorcio Hospital General Universitario de Valencia
    • Contact: Francesc Puchades, MD
  • Zaragoza, Spain, 50009
    • Not yet recruiting
    • Hospital Universitario Miguel Servet
    • Contact: Mercedes Clerencia, MD
  • Zaragoza, Spain, 50009
    • Not yet recruiting
    • Hospital Clinico Universitario Lozano Blesa
    • Contact: Jesús Cebollada, MD
  • A Coruña
    • Ferrol, A Coruña, Spain, 15405
      • Not yet recruiting
      • Complejo Hospitalario Universitario de Ferrol
  • Alava
    • Vitoria, Alava, Spain, 01004
      • Not yet recruiting
      • Hospital Universitario de Araba
      • Contact: Ariadna Besga Basterra, MD
  • Alicante
    • Elche, Alicante, Spain, 03293
      • Not yet recruiting
      • Hospital Universitario del Vinalopó
      • Contact: Ana Maestre, MD
  • Asturias
    • Oviedo, Asturias, Spain, 33011
      • Recruiting
      • Hospital Universitario Central de Asturias
      • Contact: Álvaro Gonzalez, MD
    • Oviedo, Asturias, Spain, 33012
      • Recruiting
      • Hospital Monte Naranco
      • Contact: Pablo Solla, MD
  • Barcelona
    • Sant Joan Despí, Barcelona, Spain, 08970
      • Not yet recruiting
      • Hospital de Sant Juan Despí
      • Contact: Laia Navarri, MD
  • Cantabria
    • Santander, Cantabria, Spain, 39008
      • Not yet recruiting
      • Hospital Universitario Marques de Valdecilla
      • Contact: Carmen García, MD
  • Castellón
    • Villa-Real, Castellón, Spain, 12540
      • Not yet recruiting
      • Hospital Universitario de La Plana
      • Contact: Alicia Balanza, MD
  • Cáceres
    • Plasencia, Cáceres, Spain, 10600
      • Recruiting
      • Hospital Virgen del Puerto Plasencia
      • Contact: Raquel Ortes, MD
  • Cádiz
    • Puerto Real, Cádiz, Spain, 11510
      • Recruiting
      • Hospital Universitario Puerto Real
      • Contact: Juan Bosco López, MD
  • Galicia
    • Santiago De Compostela, Galicia, Spain
      • Recruiting
      • Complejo Hospitalario Universitario De Santiago De Compostela
      • Contact: Álvaro Hermida, MD
  • La Rioja
    • Logroño, La Rioja, Spain, 26006
      • Recruiting
      • Hospital San Pedro
      • Contact: Ramón Baeza, MD
  • Las Palmas
    • Arrecife, Las Palmas, Spain, 35500
      • Not yet recruiting
      • Hospital Universitario Doctor José Molina Orosa
      • Contact: Blanca Torres, MD
  • León
    • Ponferrada, León, Spain, 24404
      • Recruiting
      • Hospital del Bierzo
      • Contact: Javier Pérez-Jara, MD
  • Madrid
    • Getafe, Madrid, Spain, 28905
      • Recruiting
      • Hospital Universitario de Getafe
      • Contact: Roberto Petidier, MD
    • Majadahonda, Madrid, Spain, 28222
      • Not yet recruiting
      • Hospital Universitario Puerta de Hierro
      • Contact: Marcos García, MD
    • San Sebastián De Los Reyes, Madrid, Spain, 28702
      • Recruiting
      • Hospital Infanta Sofia
      • Contact: Jorge Francisco Gómez, MD
  • Navarra
    • Pamplona, Navarra, Spain, 31008
      • Recruiting
      • Hospital Universitario de Navarra
      • Contact: Bernardo Abel Cedeño, MD
  • Pontevedra
    • Vigo, Pontevedra, Spain, 36214
      • Recruiting
      • Complejo Hospitalario Universitario de Vigo
      • Contact: Carlos Rodriguez, MD

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 (Anticipated): July 31, 2024
• Study Completion (Anticipated): December 31, 2024

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): May 11, 2023
• Last Update Submitted That Met QC Criteria: May 10, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Frailty; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; 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