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
Sites (35)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Complejo Hospitalario Universitario de A Coruña Coordinator of this site? Confirm its status | A Coruña | Spain | Unknown status |
| Hospital Universitario Nuestra Señora del Perpétuo Socorro Coordinator of this site? Confirm its status | Albacete | Spain | Unknown status |
| Hospital Vega Baja Coordinator of this site? Confirm its status | Alicante | Spain | Unknown status |
| Hospital Universitario Doctor José Molina Orosa Coordinator of this site? Confirm its status | Arrecife | Spain | Unknown status |
| Hospital Perpetuo Socorro Coordinator of this site? Confirm its status | Badajoz | Spain | Unknown status |
| Hospital del Mar Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital San Pedro De Alcántara Coordinator of this site? Confirm its status | Cáceres | Spain | Unknown status |
| Hospital Universitario de La Plana Coordinator of this site? Confirm its status | Ciudad Real | Spain | Unknown status |
| Hospital Universitario del Vinalopo Coordinator of this site? Confirm its status | Elche | Spain | Unknown status |
| Complejo Hospitalario Universitario de Ferrol Coordinator of this site? Confirm its status | Ferrol | Spain | Unknown status |
| Hospital Universitario de Getafe Coordinator of this site? Confirm its status | Getafe | Spain | Unknown status |
| Hospital Universitario Virgen de las Nieves Coordinator of this site? Confirm its status | Granada | Spain | Unknown status |
| Hospital Universitario De Leon Coordinator of this site? Confirm its status | León | Spain | Unknown status |
| Hospital San Pedro Coordinator of this site? Confirm its status | Logroño | Spain | Unknown status |
| Hospital Universitario de la Princesa Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Universitario Puerta de Hierro Coordinator of this site? Confirm its status | Majadahonda | Spain | Unknown status |
| Hospital Regional Universitario de Malaga Coordinator of this site? Confirm its status | Málaga | Spain | Unknown status |
| Hospital Monte Naranco Coordinator of this site? Confirm its status | Oviedo | Spain | Unknown status |
| Hospital Universitario Central De Asturias Coordinator of this site? Confirm its status | Oviedo | Spain | Unknown status |
| Hospital Universitario de Navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Unknown status |
| Hospital Virgen del Puerto Plasencia Coordinator of this site? Confirm its status | Plasencia | Spain | Unknown status |
| Hospital del Bierzo Coordinator of this site? Confirm its status | Ponferrada | Spain | Unknown status |
| Hospital Universitario Puerto Real Coordinator of this site? Confirm its status | Puerto Real | Spain | Unknown status |
| Hospital Infanta Sofia Coordinator of this site? Confirm its status | San Sebastián de los Reyes | Spain | Unknown status |
| Hospital Universitario Nuestra Señora de Candelaria Coordinator of this site? Confirm its status | Santa Cruz de Tenerife | Spain | Unknown status |
| Hospital Universitario Marqués de Valdecilla Coordinator of this site? Confirm its status | Santander | Spain | Unknown status |
| Complejo Hospitalario Universitario De Santiago De Compostela Coordinator of this site? Confirm its status | Santiago de Compostela | Spain | Unknown status |
| Hospital de Sant Juan Despí Coordinator of this site? Confirm its status | Sant Joan Despí | Spain | Unknown status |
| Consorcio Hospital General Universitario de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
| Hospital Clinico Universitario de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
| Hospital Universitario Y Politecnico La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
| Complejo Hospitalario Universitario de Vigo Coordinator of this site? Confirm its status | Vigo | Spain | Unknown status |
| Hospital Universitario de Araba Coordinator of this site? Confirm its status | Vitoria-Gasteiz | Spain | Unknown status |
| Hospital Clinico Universitario Lozano Blesa Coordinator of this site? Confirm its status | Zaragoza | Spain | Unknown status |
| Hospital Universitario Miguel Servet Coordinator of this site? Confirm its status | Zaragoza | Spain | Unknown status |
Related publications
- A real-world evaluation of the safety of edoxaban in frail older adults with non-valvular atrial fibrillation.Thromb Res · 2026 · PMID 41671971
This page is information, not medical advice. Discuss any trial with your doctor.