Safety Evaluation of Edoxaban in Elderly Patients With Frailty Criteria
NCT ID: NCT05732506
Last Updated: 2025-04-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
411 participants
OBSERVATIONAL
2023-02-01
2025-04-09
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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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.
Edoxaban
There are not intervention.
Interventions
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Edoxaban
There are not intervention.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
75 Years
ALL
No
Sponsors
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Galaxia Empírica
NETWORK
Responsible Party
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Principal Investigators
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Álvaro Hermida Ameijeiras
Role: PRINCIPAL_INVESTIGATOR
Locations
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Complejo Hospitalario Universitario de A Coruña
A Coruña, A Coruña, Spain
Complejo Hospitalario Universitario de Ferrol
Ferrol, A Coruña, Spain
Hospital Universitario de Áraba
Vitoria-Gasteiz, ALAVA, Spain
Hospital Universitario Nuestra Señora del Perpetuo Socorro
Albacete, Albacete, Spain
Hospital Vega Baja
Alicante, Alicante, Spain
Hospital Universitario del Vinalopó
Elche, Alicante, Spain
Hospital Perpetuo Socorro
Badajoz, Badajoz, Spain
Hospital del Mar
Barcelona, Barcelona, Spain
Hospital de Sant Juan Despí
Sant Joan Despí, Barcelona, Spain
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, Spain
Hospital Universitario de La Plana
Ciudad Real, Castellón, Spain
Hospital San Pedro de Alcántara
Cáceres, Cáceres, Spain
Hospital Virgen del Puerto Plasencia
Plasencia, Cáceres, Spain
Hospital Universitario Puerto Real
Puerto Real, Cádiz, Spain
Complejo Hospitalario Universitario de Santiago de Compostela
Santiago de Compostela, Galicia, Spain
Hospital Universitario Virgen de las Nieves
Granada, Granada, Spain
Hospital San Pedro
Logroño, La Rioja, Spain
Hospital Universitario Doctor José Molina Orosa
Arrecife, Las Palmas, Spain
Hospital Universitario de León
León, León, Spain
Hospital del Bierzo
Ponferrada, León, Spain
Hospital Universitario de Getafe
Getafe, Madrid, Spain
Hospital Universitario de La Princesa
Madrid, Madrid, Spain
Hospital Universitario Puerta De Hierro
Majadahonda, Madrid, Spain
Hospital Infanta Sofia
San Sebastián de los Reyes, Madrid, Spain
Hospital Regional Universitario de Málaga
Málaga, Málaga, Spain
Hospital Universitario de Navarra
Pamplona, Navarre, Spain
Complejo Hospitalario Universitario de Vigo
Vigo, Pontevedra, Spain
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, Spain
Hospital Monte Naranco
Oviedo, Principality of Asturias, Spain
Hospital Universitario Nuestra Señora de Candelaria
Santa Cruz de Tenerife, Santa Cruz De Tenerife, Spain
Hospital Clínico Universitario de Valencia
Valencia, Valencia, Spain
Consorcio Hospital General Universitario de Valencia
Valencia, Valencia, Spain
Hospital Universitario y Politécnico La Fe
Valencia, Valencia, Spain
Hospital Clínico Universitario Lozano Blesa
Zaragoza, Zaragoza, Spain
Hospital Universitario Miguel Servet
Zaragoza, Zaragoza, Spain
Countries
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Other Identifiers
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EDO-FRAG-001
Identifier Type: -
Identifier Source: org_study_id
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