Safety Evaluation of Edoxaban in Elderly Patients With Frailty Criteria

Auricular Fibrillation Clinical Trial

Official title:

Safety Evaluation of Edoxaban in Elderly Patients With Frailty Criteria

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05732506
• Other study ID #: EDO-FRAG-001
• Status: Recruiting
• Start date: February 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2023
• Source: Galaxia Empírica
• Contact: Antonio Domingo Pose Reino
• Phone: 605680912
• Email: antonio.pose[@]usc.es
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 456
• Est. completion date: December 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Auricular Fibrillation
• Frailty

Intervention

Drug:
• Edoxaban
There are not intervention.

Locations

Country	Name	City	State
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 Universitario Doctor José Molina Orosa	Arrecife	Las Palmas
Spain	Hospital Perpetuo Socorro	Badajoz
Spain	Hospital del Mar	Barcelona
Spain	Hospital San Pedro de Alcántara	Cáceres
Spain	Hospital Universitario del Vinalopó	Elche	Alicante
Spain	Complejo Hospitalario Universitario de Ferrol	Ferrol	A Coruña
Spain	Hospital Universitario de Getafe	Getafe	Madrid
Spain	Hospital Universitario Virgen de las Nieves	Granada
Spain	Hospital Universitario de León	León
Spain	Hospital San Pedro	Logroño	La Rioja
Spain	Hospital Universitario de La Princesa	Madrid
Spain	Hospital Universitario Puerta De Hierro	Majadahonda	Madrid
Spain	Hospital Regional Universitario de Málaga	Málaga
Spain	Hospital Monte Naranco	Oviedo	Asturias
Spain	Hospital Universitario Central de Asturias	Oviedo	Asturias
Spain	Hospital Universitario de Navarra	Pamplona	Navarra
Spain	Hospital Virgen del Puerto Plasencia	Plasencia	Cáceres
Spain	Hospital del Bierzo	Ponferrada	León
Spain	Hospital Universitario Puerto Real	Puerto Real	Cádiz
Spain	Hospital Infanta Sofia	San Sebastián De Los Reyes	Madrid
Spain	Hospital de Sant Juan Despí	Sant Joan Despí	Barcelona
Spain	Hospital Universitario Nuestra Señora de Candelaria	Santa Cruz De Tenerife
Spain	Hospital Universitario Marqués de Valdecilla	Santander	Cantabria
Spain	Complejo Hospitalario Universitario de Santiago de Compostela	Santiago De Compostela	Galicia
Spain	Consorcio Hospital General Universitario de Valencia	Valencia
Spain	Hospital Clínico Universitario de Valencia	Valencia
Spain	Hospital Universitario y Politécnico La Fe	Valencia
Spain	Complejo Hospitalario Universitario de Vigo	Vigo	Pontevedra
Spain	Hospital Universitario de La Plana	Villa-Real	Castellón
Spain	Hospital Universitario de Áraba	Vitoria	Alava
Spain	Hospital Clínico Universitario Lozano Blesa	Zaragoza
Spain	Hospital Universitario Miguel Servet	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Galaxia Empírica

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major bleeding.	Proportion of patients who had a major bleeding during the 12 months of follow-up.	12 months
Secondary	Stroke or systemic embolism.	Proportion of patients who suffered stroke or systemic embolism during the 12 months of follow-up.	12 months