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Safety Evaluation of Edoxaban in Elderly Patients With Frailty Criteria

Sponsor
Galaxia Empírica (Other)
Overall Status
Recruiting
CT.gov ID
NCT05732506
Collaborator
(none)
456
Enrollment
33
Locations
23
Anticipated Duration (Months)
13.8
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

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

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
456 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Safety Evaluation of Edoxaban in Elderly Patients With Frailty Criteria
Actual Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
Jul 31, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
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.

Drug: Edoxaban
There are not intervention.
Other Names:
  • Lixiana

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Major bleeding. [12 months]

      Proportion of patients who had a major bleeding during the 12 months of follow-up.

    Secondary Outcome Measures

    1. Stroke or systemic embolism. [12 months]

      Proportion of patients who suffered stroke or systemic embolism during the 12 months of follow-up.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    75 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 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.

    Exclusion Criteria:

    • 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital Universitario del Vinalopó Elche Alicante Spain 03293
    2 Hospital Universitario Central de Asturias Oviedo Asturias Spain 33011
    3 Hospital Monte Naranco Oviedo Asturias Spain 33012
    4 Hospital de Sant Juan Despí Sant Joan Despí Barcelona Spain 08970
    5 Hospital Universitario Marqués de Valdecilla Santander Cantabria Spain 39008
    6 Hospital Universitario de La Plana Villa-Real Castellón Spain 12540
    7 Hospital Virgen del Puerto Plasencia Plasencia Cáceres Spain 10600
    8 Hospital Universitario Puerto Real Puerto Real Cádiz Spain 11510
    9 Complejo Hospitalario Universitario de Santiago de Compostela Santiago De Compostela Galicia Spain
    10 Hospital San Pedro Logroño La Rioja Spain 26006
    11 Hospital Universitario Doctor José Molina Orosa Arrecife Las Palmas Spain 35500
    12 Hospital del Bierzo Ponferrada León Spain 24404
    13 Hospital Universitario de Getafe Getafe Madrid Spain 28905
    14 Hospital Universitario Puerta De Hierro Majadahonda Madrid Spain 28222
    15 Hospital Infanta Sofia San Sebastián De Los Reyes Madrid Spain 28702
    16 Hospital Universitario de Navarra Pamplona Navarra Spain 31008
    17 Complejo Hospitalario Universitario de Vigo Vigo Pontevedra Spain 36214
    18 Complejo Hospitalario Universitario de A Coruña A Coruña Spain 15006
    19 Hospital Universitario Nuestra Señora del Perpetuo Socorro Albacete Spain 02006
    20 Hospital Vega Baja Alicante Spain 03314
    21 Hospital Perpetuo Socorro Badajoz Spain 06010
    22 Hospital del Mar Barcelona Spain 08003
    23 Hospital San Pedro de Alcántara Cáceres Spain 10003
    24 Hospital Universitario Virgen de las Nieves Granada Spain 18014
    25 Hospital Universitario de León León Spain 24071
    26 Hospital Universitario de La Princesa Madrid Spain 28006
    27 Hospital Regional Universitario de Málaga Málaga Spain 29010
    28 Hospital Universitario Nuestra Señora de Candelaria Santa Cruz De Tenerife Spain 38010
    29 Hospital Clínico Universitario de Valencia Valencia Spain 46010
    30 Consorcio Hospital General Universitario de Valencia Valencia Spain 46014
    31 Hospital Universitario y Politécnico La Fe Valencia Spain 46026
    32 Hospital Clínico Universitario Lozano Blesa Zaragoza Spain 50009
    33 Hospital Universitario Miguel Servet Zaragoza Spain 50009

    Sponsors and Collaborators

    • Galaxia Empírica

    Investigators

    • Principal Investigator: Álvaro Hermida Ameijeiras,

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Galaxia Empírica
    ClinicalTrials.gov Identifier:
    NCT05732506
    Other Study ID Numbers:
    • EDO-FRAG-001
    First Posted:
    Feb 17, 2023
    Last Update Posted:
    Feb 17, 2023
    Last Verified:
    Feb 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Atrial Fibrillation
    Frailty
    Edoxaban

    Study Results

    No Results Posted as of Feb 17, 2023