Safety Evaluation of Edoxaban in Elderly Patients With Frailty Criteria

Last updated: May 10, 2023
Sponsor: Galaxia Empírica
Overall Status: Active - Recruiting

Phase

N/A

Condition

Arrhythmia

Chest Pain

Dysrhythmia

Treatment

Edoxaban

Clinical Study ID

NCT05732506
EDO-FRAG-001
  • Ages > 75
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 thestudy with Edoxaban for prevention of stroke and systemic embolism after diagnosis ofNVAF 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

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-Pughclassification.
  • 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 toperform 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.

Study Design

Total Participants: 456
Treatment Group(s): 1
Primary Treatment: Edoxaban
Phase:
Study Start date:
February 01, 2023
Estimated Completion Date:
December 31, 2024

Study 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.

Connect with a study center

  • Complejo Hospitalario Universitario de Ferrol

    Ferrol, A Coruña 15405
    Spain

    Site Not Available

  • Hospital Universitario de Áraba

    Vitoria, Alava 01004
    Spain

    Site Not Available

  • Hospital Universitario del Vinalopó

    Elche, Alicante 03293
    Spain

    Site Not Available

  • Hospital Monte Naranco

    Oviedo, Asturias 33012
    Spain

    Active - Recruiting

  • Hospital Universitario Central de Asturias

    Oviedo, Asturias 33011
    Spain

    Active - Recruiting

  • Hospital de Sant Juan Despí

    Sant Joan Despí, Barcelona 08970
    Spain

    Site Not Available

  • Hospital Universitario Marqués de Valdecilla

    Santander, Cantabria 39008
    Spain

    Site Not Available

  • Hospital Universitario de La Plana

    Villa-Real, Castellón 12540
    Spain

    Site Not Available

  • Hospital Virgen del Puerto Plasencia

    Plasencia, Cáceres 10600
    Spain

    Active - Recruiting

  • Hospital Universitario Puerto Real

    Puerto Real, Cádiz 11510
    Spain

    Active - Recruiting

  • Complejo Hospitalario Universitario de Santiago de Compostela

    Santiago De Compostela, Galicia
    Spain

    Active - Recruiting

  • Hospital San Pedro

    Logroño, La Rioja 26006
    Spain

    Active - Recruiting

  • Hospital Universitario Doctor José Molina Orosa

    Arrecife, Las Palmas 35500
    Spain

    Site Not Available

  • Hospital del Bierzo

    Ponferrada, León 24404
    Spain

    Active - Recruiting

  • Hospital Universitario de Getafe

    Getafe, Madrid 28905
    Spain

    Active - Recruiting

  • Hospital Universitario Puerta De Hierro

    Majadahonda, Madrid 28222
    Spain

    Site Not Available

  • Hospital Infanta Sofia

    San Sebastián De Los Reyes, Madrid 28702
    Spain

    Active - Recruiting

  • Hospital Universitario de Navarra

    Pamplona, Navarra 31008
    Spain

    Active - Recruiting

  • Complejo Hospitalario Universitario de Vigo

    Vigo, Pontevedra 36214
    Spain

    Active - Recruiting

  • Complejo Hospitalario Universitario de A Coruña

    A Coruña, 15006
    Spain

    Active - Recruiting

  • Hospital Universitario Nuestra Señora del Perpetuo Socorro

    Albacete, 02006
    Spain

    Active - Recruiting

  • Hospital Vega Baja

    Alicante, 03314
    Spain

    Active - Recruiting

  • Hospital Perpetuo Socorro

    Badajoz, 06010
    Spain

    Active - Recruiting

  • Hospital del Mar

    Barcelona, 08003
    Spain

    Active - Recruiting

  • Hospital San Pedro de Alcántara

    Cáceres, 10003
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen de las Nieves

    Granada, 18014
    Spain

    Active - Recruiting

  • Hospital Universitario de León

    León, 24071
    Spain

    Active - Recruiting

  • Hospital Universitario de La Princesa

    Madrid, 28006
    Spain

    Active - Recruiting

  • Hospital Regional Universitario de Málaga

    Málaga, 29010
    Spain

    Active - Recruiting

  • Hospital Universitario Nuestra Señora de Candelaria

    Santa Cruz De Tenerife, 38010
    Spain

    Active - Recruiting

  • Consorcio Hospital General Universitario de Valencia

    Valencia, 46014
    Spain

    Site Not Available

  • Hospital Clínico Universitario de Valencia

    Valencia, 46010
    Spain

    Site Not Available

  • Hospital Universitario y Politécnico La Fe

    Valencia, 46026
    Spain

    Active - Recruiting

  • Hospital Clínico Universitario Lozano Blesa

    Zaragoza, 50009
    Spain

    Site Not Available

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009
    Spain

    Site Not Available

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