Auricular FibrillationNCT05732506
Safety Evaluation of Edoxaban in Elderly Patients With Frailty Criteria
An observational study of Auricular Fibrillation, run by Galaxia Empírica at 35 sites in Spain.
Trial summary
The aim of the present study is to prospectively evaluate the safety of Edoxaban. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Auricular Fibrillation
- What is being tested?
- Edoxaban
- How many people
- 411 participants
- Where
- 35 sitesSpain
- Study dates
- 1 Feb 2023to 9 Apr 2025
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
35 sites in 1 country.
35 sites in 1 country
Spain35 sites
Complejo Hospitalario Universitario de A Coruña
A Coruña, A Coruña, 15006
Hospital Universitario Nuestra Señora del Perpetuo Socorro
Albacete, Albacete, 02006
Hospital Vega Baja
Alicante, Alicante, 03314
Hospital Universitario Doctor José Molina Orosa
Arrecife, Las Palmas, 35500
Hospital Perpetuo Socorro
Badajoz, Badajoz, 06010
Hospital del Mar
Barcelona, Barcelona, 08003
Hospital San Pedro de Alcántara
Cáceres, Cáceres, 10003
Hospital Universitario de La Plana
Ciudad Real, Castellón, 12540
Hospital Universitario del Vinalopó
Elche, Alicante, 03293
Complejo Hospitalario Universitario de Ferrol
Ferrol, A Coruña, 15405
Hospital Universitario de Getafe
Getafe, Madrid, 28905
Hospital Universitario Virgen de las Nieves
Granada, Granada, 18014
Hospital Universitario de León
León, León, 24071
Hospital San Pedro
Logroño, La Rioja, 26006
Hospital Universitario de La Princesa
Madrid, Madrid, 28006
Hospital Universitario Puerta De Hierro
Majadahonda, Madrid, 28222
Hospital Regional Universitario de Málaga
Málaga, Málaga, 29010
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, 33011
Hospital Monte Naranco
Oviedo, Principality of Asturias, 33012
Hospital Universitario de Navarra
Pamplona, Navarre, 31008
Hospital Virgen del Puerto Plasencia
Plasencia, Cáceres, 10600
Hospital del Bierzo
Ponferrada, León, 24404
Hospital Universitario Puerto Real
Puerto Real, Cádiz, 11510
Hospital Infanta Sofia
San Sebastián de los Reyes, Madrid, 28702
Hospital de Sant Juan Despí
Sant Joan Despí, Barcelona, 08970
Hospital Universitario Nuestra Señora de Candelaria
Santa Cruz de Tenerife, Santa Cruz De Tenerife, 38010
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, 39008
Complejo Hospitalario Universitario de Santiago de Compostela
Santiago de Compostela, Galicia
Hospital Clínico Universitario de Valencia
Valencia, Valencia, 46010
Consorcio Hospital General Universitario de Valencia
Valencia, Valencia, 46014
Hospital Universitario y Politécnico La Fe
Valencia, Valencia, 46026
Complejo Hospitalario Universitario de Vigo
Vigo, Pontevedra, 36214
Hospital Universitario de Áraba
Vitoria-Gasteiz, ALAVA, 01004
Hospital Clínico Universitario Lozano Blesa
Zaragoza, Zaragoza, 50009
Hospital Universitario Miguel Servet
Zaragoza, Zaragoza, 50009
About this study
The aim of the present study is to prospectively evaluate the safety of Edoxaban.
Read the detailed 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.
- Conditions
- Auricular Fibrillation
- Being tested
- Edoxaban
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EdoxabanDrug
Also called Lixiana
There are not intervention.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Edoxaban |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major bleeding.
Proportion of patients who had a major bleeding during the 12 months of follow-up.
Measured: 12 months
Secondary outcomes (1)
Stroke or systemic embolism.
Proportion of patients who suffered stroke or systemic embolism during the 12 months of follow-up.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2023
- Study start1 Feb 2023
- Primary completion31 Mar 2025
- Study completion9 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Auricular FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 411 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Galaxia Empírica
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Álvaro Hermida Ameijeiras, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05732506
- Sponsor's protocol ID
- EDO-FRAG-001
- Status last verified
- Apr 2025
- First submitted
- 7 Feb 2023
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 41671971
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Evaluation of Edoxaban in Elderly Patients With Frailty Criteria
- ClinicalTrials.gov ID
- NCT05732506
- Acronym / sponsor ID
- EDO-FRAG-001
- Conditions
- Auricular Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 411 participants (actual)
- Lead sponsor
- Galaxia EmpíricaResearch network
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 9 Apr 2025 (actual)
- First posted
- 17 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the present study is to prospectively evaluate the safety of Edoxaban.
Detailed 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Drug: EdoxabanElderly 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. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EdoxabanAlso: LixianaThere are not intervention. | Drug | Patients |
Primary outcome
Major bleeding.
Time frame: 12 months
Proportion of patients who had a major bleeding during the 12 months of follow-up.
1 secondary outcome
Stroke or systemic embolism.
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
- Derived from this study: PubMed 41671971Hermida-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.
- Individual participant dataSharing planned: Undecided
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Álvaro Hermida Ameijeiras principal investigator
35 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Auricular Fibrillation, run by Galaxia Empírica at 35 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major bleeding. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05732506, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2025.