Evaluation of Treatment Safety in Patients With Atrial Fibrillation on Edoxaban Therapy in Real-Life in Turkey

Study Overview
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Brief Summary
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This is a national, multi-center, prospective study to evaluate the safety of Edoxaban in patients diagnosed with AF who are currently using Edoxaban for stroke prevention. The primary objective: To evaluate safety of Edoxaban treatment in patients with atrial fibrillation (AF) on Edoxaban therapy in routine clinical practice in Turkey.

Detailed Description
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Edoxaban was recently approved by The Turkish Medicines and Medical Devices Agency for the prevention of stroke and systemic embolism in adult patients with Nonvalvular Atrial Fibrillation (NVAF) with one or more risk factors, such as congestive heart failure, hypertension, diabetes mellitus, prior stroke or transient ischemic attack (TIA). Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and prevention of recurrent DVT and PE in adults. The study will evaluate the safety of Edoxaban in patients diagnosed with AF who are currently on Edoxaban therapy for prevention of stroke in routine clinical practice in Turkey for stroke prevention up to 1 year following treatment by specialized as well as non-specialized physicians in hospital centers.

Official Title
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Evaluation of Treatment Safety in Patients With Atrial Fibrillation on Edoxaban Therapy in Real-Life in Turkey (ETAF-TR)

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: Atrial fibrillation (AF) patients aged 18 years or above who are currently using Edoxaban for prevention of stroke. Has provided written informed consent to participate in the study. Exclusion Criteria: Not on Edoxaban therapy on the date of obtaining Informed consent Receiving Edoxaban therapy for an indication other than the relevant indication (stroke prevention in AF) Participating in another ongoing clinical study will also be excluded.

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 |
| --- | --- |
| Study Group<br>Patients diagnosed with AF who are currently using Edoxaban for stroke prevention in Turkey. | Drug: Edoxaban<br>* Edoxaban according to Package Information (Summary of Product Characteristics [SmPC]).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with Overt bleeding following Edoxaban therapy in routine clinical practice in Turkey | Overt bleeding is defined as major bleeding or clinically relevant non-major bleeding (CRNM) or any bleeding that does not meet this definition but is considered as overt bleeding by the participating physician. Rates of overt bleeding events will be presented as raw incidence rate (number of patients with events / number of patients treated) and as incidence rates per patient-year (e.g. number of patients with events per 100 patient-years). | From baseline up to 1 year post enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients with Clinically relevant non-major bleeding following Edoxaban therapy in routine clinical practice in Turkey | Rates of clinically relevant non-major bleeding events will be presented as raw incidence rate (number of patients with events / number of patients treated) and as incidence rates per patient-year (e.g. number of patients with events per 100 patient-years). | From baseline up to 1 year post enrollment | 
| Number of Patients with Major bleeding following Edoxaban therapy in routine clinical practice in Turkey | Rates of major bleeding events will be presented as raw incidence rate (number of patients with events / number of patients treated) and as incidence rates per patient-year (e.g. number of patients with events per 100 patient-years). | From baseline up to 1 year post enrollment | 
| Number of Patients with Net Clinical Benefit following Edoxaban therapy in routine clinical practice in Turkey | Rates of net clinical benefit will be presented as raw benefit rate (number of patients with benefits / number of patients treated) and as incidence rates per patient-year (e.g. number of patients with events per 100 patient-years). | From baseline up to 1 year post enrollment | 
| Number of Patients with Stroke, transient ischemic attack and systemic embolism following Edoxaban therapy in routine clinical practice in Turkey | Rates of stroke, transient ischemic attack and systemic embolism events will be presented as raw incidence rate (number of patients with events / number of patients treated) and as incidence rates per patient-year (e.g. number of patients with events per 100 patient-years). | From baseline up to 1 year post enrollment | 
| Number of Patients with Major Cardiovascular Events Following Edoxaban Therapy in Routine Clinical Practice in Turkey | Rates of major cardiovascular events will be presented as raw incidence rate (number of patients with events / number of patients treated) and as incidence rates per patient-year (e.g. number of patients with events per 100 patient-years). | From baseline up to 1 year post enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Edoxaban, Atrial Fibrillation, Nonvalvular Atrial Fibrillation (NVAF), Non-vitamin K Oral Anticoagulants (NOACs), Real World Evidence (RWE), Turkey