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

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

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

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Drug: Edoxaban


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Edoxaban<br>Patients with established Non Valvular Atrial Fibrillation (NVAF) treated with edoxaban according to Summary of Product Characteristics (SmPC). Physician's prescribing behaviour will not be influenced, patients may only be included after the treating physician has made the clinical decision to prescribe edoxaban. | Drug: Edoxaban<br>* Prescribed according to approved label<br>* Other names: Lixiana;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Experiencing Real-World Safety Data Events 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 | within 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants with Patient Relevant Outcomes | 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. | within 4 years | 
| Percentage of Participants Compliant with Edoxaban Therapy | Categories: Always, Almost Always, Most of the Time, Less than Half the Time, Unknown | over 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nonvalvular Atrial Fibrillation, Post Authorisation Safety Study, Safety, Real World Evidence