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The aim of the present study is to prospectively evaluate the safety of Edoxaban.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Edoxaban | Drug | There are not intervention. |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Major bleeding. | Proportion of patients who had a major bleeding during the 12 months of follow-up. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Stroke or systemic embolism. | Proportion of patients who suffered stroke or systemic embolism during the 12 months of follow-up. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Álvaro Hermida Ameijeiras | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Complejo Hospitalario Universitario de A Coruña | A Coruña | A Coruña | 15006 | Spain | ||
| Complejo Hospitalario Universitario de Ferrol |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41671971 | Derived | Hermida-Ameijeiras A, Vazquez-Agra N, Rodriguez-Pascual C, Cedeno-Veloz BA, Baeza-Trinidad R, Solla-Suarez P, Lopez-Saez JB, Gomez-Huelgas R, Freire-Castro SJ, Balanza-Garzon A, Roqueta C, Pose-Reino A. A real-world evaluation of the safety of edoxaban in frail older adults with non-valvular atrial fibrillation. Thromb Res. 2026 Mar;259:109614. doi: 10.1016/j.thromres.2026.109614. Epub 2026 Feb 9. |
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| Ferrol |
| A Coruña |
| 15405 |
| Spain |
| Hospital Universitario de Áraba | Vitoria-Gasteiz | ALAVA | 01004 | Spain |
| Hospital Universitario Nuestra Señora del Perpetuo Socorro | Albacete | Albacete | 02006 | Spain |
| Hospital Vega Baja | Alicante | Alicante | 03314 | Spain |
| Hospital Universitario del Vinalopó | Elche | Alicante | 03293 | Spain |
| Hospital Perpetuo Socorro | Badajoz | Badajoz | 06010 | Spain |
| Hospital del Mar | Barcelona | Barcelona | 08003 | Spain |
| Hospital de Sant Juan Despí | Sant Joan Despí | Barcelona | 08970 | Spain |
| Hospital Universitario Marqués de Valdecilla | Santander | Cantabria | 39008 | Spain |
| Hospital Universitario de La Plana | Ciudad Real | Castellón | 12540 | Spain |
| Hospital San Pedro de Alcántara | Cáceres | Cáceres | 10003 | Spain |
| Hospital Virgen del Puerto Plasencia | Plasencia | Cáceres | 10600 | Spain |
| Hospital Universitario Puerto Real | Puerto Real | Cádiz | 11510 | Spain |
| Complejo Hospitalario Universitario de Santiago de Compostela | Santiago de Compostela | Galicia | Spain |
| Hospital Universitario Virgen de las Nieves | Granada | Granada | 18014 | Spain |
| Hospital San Pedro | Logroño | La Rioja | 26006 | Spain |
| Hospital Universitario Doctor José Molina Orosa | Arrecife | Las Palmas | 35500 | Spain |
| Hospital Universitario de León | León | León | 24071 | Spain |
| Hospital del Bierzo | Ponferrada | León | 24404 | Spain |
| Hospital Universitario de Getafe | Getafe | Madrid | 28905 | Spain |
| Hospital Universitario de La Princesa | Madrid | Madrid | 28006 | Spain |
| Hospital Universitario Puerta De Hierro | Majadahonda | Madrid | 28222 | Spain |
| Hospital Infanta Sofia | San Sebastián de los Reyes | Madrid | 28702 | Spain |
| Hospital Regional Universitario de Málaga | Málaga | Málaga | 29010 | Spain |
| Hospital Universitario de Navarra | Pamplona | Navarre | 31008 | Spain |
| Complejo Hospitalario Universitario de Vigo | Vigo | Pontevedra | 36214 | Spain |
| Hospital Universitario Central de Asturias | Oviedo | Principality of Asturias | 33011 | Spain |
| Hospital Monte Naranco | Oviedo | Principality of Asturias | 33012 | Spain |
| Hospital Universitario Nuestra Señora de Candelaria | Santa Cruz de Tenerife | Santa Cruz De Tenerife | 38010 | Spain |
| Hospital Clínico Universitario de Valencia | Valencia | Valencia | 46010 | Spain |
| Consorcio Hospital General Universitario de Valencia | Valencia | Valencia | 46014 | Spain |
| Hospital Universitario y Politécnico La Fe | Valencia | Valencia | 46026 | Spain |
| Hospital Clínico Universitario Lozano Blesa | Zaragoza | Zaragoza | 50009 | Spain |
| Hospital Universitario Miguel Servet | Zaragoza | Zaragoza | 50009 | Spain |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C552171 | edoxaban |
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