Trial document




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  DRKS00007912

Trial Description

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Title

Non-interventional study on Edoxaban treatment in routine clinical practice for patients with non valvular atrial fibrillation

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Trial Acronym

ETNA-AF-Europe

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URL of the Trial

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Brief Summary in Lay Language

The study is purely observational and will only collect data from medical records of patients suffering from atrial fibrillation treated with Lixiana® (Edoxaban). No additional examinations will be carried out for this study. Patients' medical treatment by their doctor will be performed according to routine clinical practice.
The purpose of this study is to collect information about patients' health, how well they tolerate Lixiana® and how it is used in routine clinical practice by the physicians in patients with Atrial Fibrillation.
The study will be performed in 12 European countries and aims to enrol a total of approximately 13100 patients from 1500 sites.
According to routine clinical practice, the study sites will see their patients on a yearly basis to check their health status, and will record the respective data in the study database. It is planned that patients' participation in this study will be completed after 4 years.

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Brief Summary in Scientific Language

Edoxaban has recently been approved by the European Medicines Agency EMA for the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors, as well as for the treatment of adult patients with venous thromboembolism and the prevention of recurrent venous thromboembolism.
This post-authorization safety study aims to collect additional information regarding the risks and benefits of Edoxaban use in a real-world clinical setting and to gain further insight into the safety (bleeding, liver adverse events, and other drug related adverse events) of Edoxaban use in non-preselected patients with non-valvular atrial fibrillation (NVAF).
Real world evidence data of routine clinical practice use of Edoxaban up to 4 years will be collected in 13100 patients, treated by specialized as well as non-specialized physicians in hospitals and office based centres.

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Organizational Data

  •   DRKS00007912
  •   2015/07/30
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  •   no
  •   Approved
  •   2015-090-f-S, Ethik-Kommission der Ärztekammer Westfalen-Lippe und der med. Fakultät der Westfälischen Wilhelms-Universität Münster
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Secondary IDs

  •   DSE-EDO-04-14  (Studiennummer/Study No.)
  •   ENCEPP/SDPP/8896  (ENCEPP (EU PAS Register))
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Health Condition or Problem studied

  •   I48 -  Atrial fibrillation and flutter
  •   10003658: Atrial fibrillation
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Interventions/Observational Groups

  •   - Patients from different countries and care settings (primary and secondary care and different specialties) with non-valvular atrial fibrillation treated with Edoxaban according to Summary of Product Characteristics (SmPC)
    - Number of recommended visits: 5 – Baseline (BL) plus one visit every 12 months, plus Edoxaban treatment discontinuation visit if applicable, plus final assessment
    - Patients who permanently discontinue Edoxaban during the observation period will be followed-up annually as well
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

The primary objective of this study is to collect real-world safety data on bleeding events including intracranial haemorrhage, drug related adverse events such as liver adverse events, cardiovascular (CV) and all-cause mortality in AF patients treated with Edoxaban up to 4 years. Furthermore, subgroup analyses will be performed in predefined patient populations, such as patients with renal or hepatic impairment.

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Secondary Outcome

To assess the effect of Edoxaban on patient relevant outcomes as strokes, systemic embolic events, major cardiovascular (CV) events, hospitalisations related to CV condition, persistence to therapy, patient/physician reported outcome, health care utilization, resource use

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Countries of Recruitment

  •   Belgium
  •   Germany
  •   France
  •   Ireland
  •   Italy
  •   Netherlands
  •   Austria
  •   Portugal
  •   Switzerland
  •   Spain
  •   United Kingdom
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2015/08/14
  •   13100
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Patients with non-valvular atrial fibrillation treated with Edoxaban according to Summary of Product Characteristics (SmPC).
Written informed consent for participation in the study
Not simultaneously participating in any interventional study
As this is a non-interventional study, no additional selection criteria apply. Patients will only be included in the study after the treating physician has made the clinical decision to prescribe Edoxaban. The prescribing behaviour will not be influenced.

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Exclusion Criteria

Not applicable

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Addresses

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    • Daiichi Sankyo Europe GmbH
    • Zielstattstr. 48
    • 81379  München
    • Germany
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    • Daiichi Sankyo Europe GmbH
    • Ms.  Dr.  Petra  Laeis 
    • Zielstattstr. 48
    • 81379  Muenchen
    • Germany
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    • Daiichi Sankyo Europe GmbH
    • Ms.  Dr.  Petra  Laeis 
    • Zielstattstr. 48
    • 81379  Muenchen
    • Germany
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Sources of Monetary or Material Support

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    • Daiichi Sankyo Europe GmbH
    • Zielstattstr. 48
    • 81379  München
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.