Safety Evaluation of Edoxaban in Elderly Patients With Frailty Criteria
1 other identifier
observational
411
1 country
35
Brief Summary
The aim of the present study is to prospectively evaluate the safety of Edoxaban.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2023
Typical duration for all trials
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2023
CompletedFirst Submitted
Initial submission to the registry
February 7, 2023
CompletedFirst Posted
Study publicly available on registry
February 17, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 9, 2025
CompletedApril 11, 2025
April 1, 2025
2.2 years
February 7, 2023
April 9, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Major bleeding.
Proportion of patients who had a major bleeding during the 12 months of follow-up.
12 months
Secondary Outcomes (1)
Stroke or systemic embolism.
12 months
Study Arms (1)
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.
Interventions
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Galaxia Empíricalead
Study Sites (35)
Complejo Hospitalario Universitario de A Coruña
A Coruña, A Coruña, 15006, Spain
Complejo Hospitalario Universitario de Ferrol
Ferrol, A Coruña, 15405, Spain
Hospital Universitario de Áraba
Vitoria-Gasteiz, ALAVA, 01004, Spain
Hospital Universitario Nuestra Señora del Perpetuo Socorro
Albacete, Albacete, 02006, Spain
Hospital Vega Baja
Alicante, Alicante, 03314, Spain
Hospital Universitario del Vinalopó
Elche, Alicante, 03293, Spain
Hospital Perpetuo Socorro
Badajoz, Badajoz, 06010, Spain
Hospital del Mar
Barcelona, Barcelona, 08003, Spain
Hospital de Sant Juan Despí
Sant Joan Despí, Barcelona, 08970, Spain
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, 39008, Spain
Hospital Universitario de La Plana
Ciudad Real, Castellón, 12540, Spain
Hospital San Pedro de Alcántara
Cáceres, Cáceres, 10003, Spain
Hospital Virgen del Puerto Plasencia
Plasencia, Cáceres, 10600, Spain
Hospital Universitario Puerto Real
Puerto Real, Cádiz, 11510, Spain
Complejo Hospitalario Universitario de Santiago de Compostela
Santiago de Compostela, Galicia, Spain
Hospital Universitario Virgen de las Nieves
Granada, Granada, 18014, Spain
Hospital San Pedro
Logroño, La Rioja, 26006, Spain
Hospital Universitario Doctor José Molina Orosa
Arrecife, Las Palmas, 35500, Spain
Hospital Universitario de León
León, León, 24071, Spain
Hospital del Bierzo
Ponferrada, León, 24404, Spain
Hospital Universitario de Getafe
Getafe, Madrid, 28905, Spain
Hospital Universitario de La Princesa
Madrid, Madrid, 28006, Spain
Hospital Universitario Puerta De Hierro
Majadahonda, Madrid, 28222, Spain
Hospital Infanta Sofia
San Sebastián de los Reyes, Madrid, 28702, Spain
Hospital Regional Universitario de Málaga
Málaga, Málaga, 29010, Spain
Hospital Universitario de Navarra
Pamplona, Navarre, 31008, Spain
Complejo Hospitalario Universitario de Vigo
Vigo, Pontevedra, 36214, Spain
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, 33011, Spain
Hospital Monte Naranco
Oviedo, Principality of Asturias, 33012, Spain
Hospital Universitario Nuestra Señora de Candelaria
Santa Cruz de Tenerife, Santa Cruz De Tenerife, 38010, Spain
Hospital Clínico Universitario de Valencia
Valencia, Valencia, 46010, Spain
Consorcio Hospital General Universitario de Valencia
Valencia, Valencia, 46014, Spain
Hospital Universitario y Politécnico La Fe
Valencia, Valencia, 46026, Spain
Hospital Clínico Universitario Lozano Blesa
Zaragoza, Zaragoza, 50009, Spain
Hospital Universitario Miguel Servet
Zaragoza, Zaragoza, 50009, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Álvaro Hermida Ameijeiras
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Years
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 7, 2023
First Posted
February 17, 2023
Study Start
February 1, 2023
Primary Completion
March 31, 2025
Study Completion
April 9, 2025
Last Updated
April 11, 2025
Record last verified: 2025-04