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.
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.
Study Type
OBSERVATIONAL
Enrollment
1,053
Edoxaban according to Package Information (Summary of Product Characteristics \[SmPC\]).
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).
Time frame: From baseline up to 1 year post enrollment
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).
Time frame: 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).
Time frame: 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).
Time frame: From baseline up to 1 year post enrollment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Başkent University Alanya Practice and Research Hospital, Cardiology Clinic
Antalya, Alanya, Turkey (Türkiye)
Ordu University Training and Research Hospital
Ordu, Altinordu, Turkey (Türkiye)
Dokuz Eylül University Research and Practice Hospital, Department of Cardiology
Izmir, Balçova, Turkey (Türkiye)
Ege University Hospital, Department of Cardiology
Izmir, Bornova, Turkey (Türkiye)
Ankara City Hospital, Cardiology Clinic
Ankara, Cankaya, Turkey (Türkiye)
Izmir Çiğli Regional Training Hospital, Cardiology Clinic
Izmir, Cigli, Turkey (Türkiye)
Aydın Adnan Menderes University Practice and Research Hospital, Department of Cardiology
Aydin, Efeler, Turkey (Türkiye)
Private Medinova Hospital, Cardiology Clinic
Aydin, Efeler, Turkey (Türkiye)
Istanbul Bezmialem Foundation University, Faculty of Medicine Hospital, Cardiology Clinic
Istanbul, Fatih, Turkey (Türkiye)
Health Sciences University Samsun Training and Research Hospital, Cardiology Clinic
Samsun, İlkadım, Turkey (Türkiye)
...and 35 more locations
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).
Time frame: 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).
Time frame: From baseline up to 1 year post enrollment