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Completed

NCT Number: NCT04594915

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

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.

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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

Başkent University Alanya Practice and Research Hospital, Cardiology Clinic, Antalya, Alanya, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Edoxaban

Drug

Edoxaban according to Package Information (Summary of Product Characteristics [SmPC]).

Primary outcomes

  1. Number of patients with Overt bleeding following Edoxaban therapy in routine clinical practice in Turkey

    Time frame: From baseline up to 1 year post enrollment

    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).

Secondary outcomes

  1. Number of Patients with Clinically relevant non-major bleeding following Edoxaban therapy in routine clinical practice in Turkey

    Time frame: From baseline up to 1 year post enrollment

    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).

  2. Number of Patients with Major bleeding following Edoxaban therapy in routine clinical practice in Turkey

    Time frame: From baseline up to 1 year post enrollment

    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).

  3. Number of Patients with Net Clinical Benefit following Edoxaban therapy in routine clinical practice in Turkey

    Time frame: From baseline up to 1 year post enrollment

    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).

  4. Number of Patients with Stroke, transient ischemic attack and systemic embolism following Edoxaban therapy in routine clinical practice in Turkey

    Time frame: From baseline up to 1 year post enrollment

    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).

  5. Number of Patients with Major Cardiovascular Events Following Edoxaban Therapy in Routine Clinical Practice in Turkey

    Time frame: From baseline up to 1 year post enrollment

    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).

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo Turkey, a Daiichi Sankyo Company

Industry

Collaborators

  • Daiichi Sankyo

Registry information

Official study title

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

Acronym: ETAF-TR

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Oct 20, 2020
Registry last updated
Jul 3, 2023

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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