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Completed

NCT Number: NCT02944019

Edoxaban Treatment in Routine Clinical Practice for Patients With Non Valvular Atrial Fibrillation

In order to understand the risks and benefits of edoxaban use in a real-world clinical setting in the Non-valvular Atrial Fibrillation (NVAF) indication, Daiichi-Sankyo proposed this post-authorization safety study (PASS) to gain insight into the safety (bleeding, liver adverse events, all-cause mortality and other drug related adverse events) of edoxaban use in patients with NVAF who were not preselected.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Wahlarzt Ordination, Dr. Paul Pinter, Altenmarkt, Altenmarkt, Austria

Loading trial locations.

About this study

Patients will be from 10 different European countries and care settings (primary and secondary care and different specialties). A one-year patient recruitment period per country is planned, but it could be longer if patient recruitment numbers are not reached. Patient data will be documented at baseline (BL), one annual data documentation point during the four-year follow up (FU), and at final assessment. Patients who permanently discontinue edoxaban during the observation period will continue to be followed annually for a further two years, or until the end of the observational period (whichever comes first).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • NVAF-patients treated with edoxaban according to Summary of Product Characteristics (SmPC).
  • Written informed consent for participation in the study (ICF).
  • Not simultaneously participating in any interventional study.

Exclusion criteria

  • None

Treatment and study plan

Edoxaban

Drug

Prescribed according to approved label

Other names: Lixiana

Primary outcomes

  1. Percentage of Participants Experiencing Real-World Safety Data Events within 4 Years

    Time frame: within 4 years

    Real-world safety data events include bleeding events including intracranial haemorrhage, drug related adverse events such as liver adverse events, cardiovascular (CV) and all-cause mortality

Secondary outcomes

  1. Percentage of Participants with Patient Relevant Outcomes

    Time frame: within 4 years

    Patient relevant outcomes include Strokes (ischaemic and haemorrhagic) , Systemic Embolic Events (SEE), Transient Ischemic Attack (TIA), Major Adverse Cardiovascular Events (MACE), Venous Thromboembolism (VTE), Acute Coronary Syndrome (ACS), and Hospitalisations related to a CV condition.

  2. Percentage of Participants Compliant with Edoxaban Therapy

    Time frame: over 4 years

    Categories: Always, Almost Always, Most of the Time, Less than Half the Time, Unknown

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo

Industry

Registry information

Official study title

Non-Interventional Study on Edoxaban Treatment in Routine Clinical Practice for Patients With Non Valvular Atrial Fibrillation

Acronym: ETNA-AF-EU

Important dates

Study start
2015
Primary completion
2022
Study completion
2022
First posted
Oct 25, 2016
Registry last updated
Jun 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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