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NCT05732506Completed

Safety Evaluation of Edoxaban in Elderly Patients With Frailty Criteria

Source: ClinicalTrials.gov · Last updated 11 Apr 2025

Brief summary (registry, in English)

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

Status (registry)
Completed
Study type
Observational
Enrollment
411 (actual)
First submitted
7 Feb 2023
Start date
1 Feb 2023
Primary completion date
31 Mar 2025
Lead sponsor
Galaxia Empírica
NCT number
NCT05732506

What you commit to

  • Study type: Observational
  • Participants enrolled: 411
  • From 1 Feb 2023 to the primary completion date, 31 Mar 2025
  • 35 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Participation in any clinical drug trial in the 2 months prior to the initial visit.
  • Surgical or percutaneous occlusion of the left atrial appendage or intention to perform such intervention at the time of inclusion.

Other illness

  • Moderate or severe hepatic insufficiency (Defined as grade B or C of the Child-Pugh classification.

Lab values

  • Creatinine clearance according to the CKD-EPI formula less than 15 ml/min/m2

Other

  • Contraindication to receive Edoxaban according to the Technical Data Sheet.
  • 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.

Who the study is looking for

  • 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.

Age in the registry: 75 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (35)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Complejo Hospitalario Universitario de A Coruña
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A CoruñaSpainUnknown status
Hospital Universitario Nuestra Señora del Perpétuo Socorro
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AlbaceteSpainUnknown status
Hospital Vega Baja
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AlicanteSpainUnknown status
Hospital Universitario Doctor José Molina Orosa
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ArrecifeSpainUnknown status
Hospital Perpetuo Socorro
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BadajozSpainUnknown status
Hospital del Mar
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BarcelonaSpainUnknown status
Hospital San Pedro De Alcántara
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CáceresSpainUnknown status
Hospital Universitario de La Plana
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Ciudad RealSpainUnknown status
Hospital Universitario del Vinalopo
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ElcheSpainUnknown status
Complejo Hospitalario Universitario de Ferrol
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FerrolSpainUnknown status
Hospital Universitario de Getafe
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GetafeSpainUnknown status
Hospital Universitario Virgen de las Nieves
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GranadaSpainUnknown status
Hospital Universitario De Leon
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LeónSpainUnknown status
Hospital San Pedro
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LogroñoSpainUnknown status
Hospital Universitario de la Princesa
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MadridSpainUnknown status
Hospital Universitario Puerta de Hierro
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MajadahondaSpainUnknown status
Hospital Regional Universitario de Malaga
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MálagaSpainUnknown status
Hospital Monte Naranco
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OviedoSpainUnknown status
Hospital Universitario Central De Asturias
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OviedoSpainUnknown status
Hospital Universitario de Navarra
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PamplonaSpainUnknown status
Hospital Virgen del Puerto Plasencia
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PlasenciaSpainUnknown status
Hospital del Bierzo
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PonferradaSpainUnknown status
Hospital Universitario Puerto Real
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Puerto RealSpainUnknown status
Hospital Infanta Sofia
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San Sebastián de los ReyesSpainUnknown status
Hospital Universitario Nuestra Señora de Candelaria
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Santa Cruz de TenerifeSpainUnknown status
Hospital Universitario Marqués de Valdecilla
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SantanderSpainUnknown status
Complejo Hospitalario Universitario De Santiago De Compostela
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Santiago de CompostelaSpainUnknown status
Hospital de Sant Juan Despí
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Sant Joan DespíSpainUnknown status
Consorcio Hospital General Universitario de Valencia
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ValenciaSpainUnknown status
Hospital Clinico Universitario de Valencia
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ValenciaSpainUnknown status
Hospital Universitario Y Politecnico La Fe
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ValenciaSpainUnknown status
Complejo Hospitalario Universitario de Vigo
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VigoSpainUnknown status
Hospital Universitario de Araba
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Vitoria-GasteizSpainUnknown status
Hospital Clinico Universitario Lozano Blesa
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ZaragozaSpainUnknown status
Hospital Universitario Miguel Servet
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ZaragozaSpainUnknown status

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This page is information, not medical advice. Discuss any trial with your doctor.