Clinical trial NCT05732506: Safety Evaluation of Edoxaban in Elderly Patients With Frailty Criteria
Official title: Safety Evaluation of Edoxaban in Elderly Patients With Frailty Criteria
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Auricular Fibrillation
Lead sponsor: Galaxia Empírica
Sponsor class: NETWORK
First posted: 2023-02-17
Enrollment: 411
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Major bleeding.
timeFrame: 12 months
Secondary outcomes:
measure: Stroke or systemic embolism.
timeFrame: 12 months
Other outcomes:
Locations:
city: Ferrol
country: Spain
facility: Complejo Hospitalario Universitario de Ferrol
state: A Coruña
city: Vitoria
country: Spain
facility: Hospital Universitario de Áraba
state: Alava
city: Elche
country: Spain
facility: Hospital Universitario del Vinalopó
state: Alicante
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
state: Asturias
city: Oviedo
country: Spain
facility: Hospital Monte Naranco
state: Asturias
city: Sant Joan Despí
country: Spain
facility: Hospital de Sant Juan Despí
state: Barcelona
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
state: Cantabria
city: Villa-Real
country: Spain
facility: Hospital Universitario de La Plana
state: Castellón
city: Plasencia
country: Spain
facility: Hospital Virgen del Puerto Plasencia
state: Cáceres
city: Puerto Real
country: Spain
facility: Hospital Universitario Puerto Real
state: Cádiz
city: Santiago De Compostela
country: Spain
facility: Complejo Hospitalario Universitario de Santiago de Compostela
state: Galicia
city: Logroño
country: Spain
facility: Hospital San Pedro
state: La Rioja
city: Arrecife
country: Spain
facility: Hospital Universitario Doctor José Molina Orosa
state: Las Palmas
city: Ponferrada
country: Spain
facility: Hospital del Bierzo
state: León
city: Getafe
country: Spain
facility: Hospital Universitario de Getafe
state: Madrid
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta De Hierro
state: Madrid
city: San Sebastián De Los Reyes
country: Spain
facility: Hospital Infanta Sofia
state: Madrid
city: Pamplona
country: Spain
facility: Hospital Universitario de Navarra
state: Navarra
city: Vigo
country: Spain
facility: Complejo Hospitalario Universitario de Vigo
state: Pontevedra
city: A Coruña
country: Spain
facility: Complejo Hospitalario Universitario de A Coruña
city: Albacete
country: Spain
facility: Hospital Universitario Nuestra Señora del Perpetuo Socorro
city: Alicante
country: Spain
facility: Hospital Vega Baja
city: Badajoz
country: Spain
facility: Hospital Perpetuo Socorro
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Cáceres
country: Spain
facility: Hospital San Pedro de Alcántara
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves
city: León
country: Spain
facility: Hospital Universitario de León
city: Madrid
country: Spain
facility: Hospital Universitario de La Princesa
city: Málaga
country: Spain
facility: Hospital Regional Universitario de Málaga
city: Santa Cruz De Tenerife
country: Spain
facility: Hospital Universitario Nuestra Señora de Candelaria
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
city: Valencia
country: Spain
facility: Consorcio Hospital General Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital Universitario y Politécnico La Fe
city: Zaragoza
country: Spain
facility: Hospital Clínico Universitario Lozano Blesa
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
Study officials:
name: Álvaro Hermida Ameijeiras
role: PRINCIPAL_INVESTIGATOR
References: