Evaluation of Treatment Safety in Patients With Atrial Fibrillation on Edoxaban Therapy in Real-Life in Turkey
- Registration Number
- NCT04594915
- Lead Sponsor
- Daiichi Sankyo Turkey, a Daiichi Sankyo Company
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1053
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Study Group Edoxaban Patients diagnosed with AF who are currently using Edoxaban for stroke prevention in Turkey.
- Primary Outcome Measures
Name Time Method Number of patients with Overt bleeding following Edoxaban therapy in routine clinical practice in Turkey 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 Outcome Measures
Name Time Method Number of Patients with Clinically relevant non-major bleeding following Edoxaban therapy in routine clinical practice in Turkey 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).
Number of Patients with Major bleeding following Edoxaban therapy in routine clinical practice in Turkey 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).
Number of Patients with Net Clinical Benefit following Edoxaban therapy in routine clinical practice in Turkey 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).
Number of Patients with Stroke, transient ischemic attack and systemic embolism following Edoxaban therapy in routine clinical practice in Turkey 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).
Number of Patients with Major Cardiovascular Events Following Edoxaban Therapy in Routine Clinical Practice in Turkey 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).
Trial Locations
- Locations (45)
İstanbul Mehmet Akif Ersoy Göğüs Kalp ve Damar Cerrahisi EAH
🇹🇷Istanbul, Turkey
Tekirdağ Şehir Hastanesi
🇹🇷Tekirdağ, Turkey
Başkent University Alanya Practice and Research Hospital, Cardiology Clinic
🇹🇷Antalya, Alanya, Turkey
Ege University Hospital, Department of Cardiology
🇹🇷İzmir, Bornova, Turkey
Aydın Adnan Menderes University Practice and Research Hospital, Department of Cardiology
🇹🇷Aydın, Efeler, Turkey
Medical Park Izmir Hospital, Cardiology Clinic
🇹🇷İzmir, Karsiyaka, Turkey
Muğla Sıtkı Koçman University Training and Research Hospital, Department of Cardiology
🇹🇷Muğla, Mentese, Turkey
Balıkesir University Health Practice and Research Hospital, Cardiology Clinic
🇹🇷Balıkesir, Merkez, Turkey
Tokat Gaziosmanpaşa University, Health Research and Practice Center, Cardiology Department
🇹🇷Tokat, Merkez, Turkey
Çanakkale Onsekiz Mart University Health Application and Research Hospital, Department of Cardiology
🇹🇷Çanakkale, Merkez, Turkey
Bursa City Hospital, Cardiology Clinic
🇹🇷Bursa, Nilüfer, Turkey
Konya Numune Hospital, Cardiology Clinic
🇹🇷Konya, Selcuklu, Turkey
Manisa Celal Bayar University Hafsa Sultan Hospital, Department of Cardiology
🇹🇷Manisa, Yunusemre, Turkey
Ankara Üniversitesi Tıp Fakültesi
🇹🇷Ankara, Turkey
Özel Koru Sincan Hastanesi
🇹🇷Ankara, Turkey
Medicana International Ankara Hastanesi
🇹🇷Ankara, Turkey
Dr. Ersin Arslan Eğitim ve Araştırma Hastanesi
🇹🇷Gaziantep, Turkey
İstanbul Bahçelievler Devlet Hastanesi
🇹🇷Istanbul, Turkey
İstanbul Kartal Koşuyolu Yüksek İhtisas EAH
🇹🇷Istanbul, Turkey
Trabzon Ahi Evren Göğüs Kalp ve Damar Cerrahisi EAH
🇹🇷Trabzon, Turkey
Ordu University Training and Research Hospital
🇹🇷Ordu, Altinordu, Turkey
Dokuz Eylül University Research and Practice Hospital, Department of Cardiology
🇹🇷İzmir, Balçova, Turkey
Izmir Çiğli Regional Training Hospital, Cardiology Clinic
🇹🇷İzmir, Cigli, Turkey
Private Medinova Hospital, Cardiology Clinic
🇹🇷Aydın, Efeler, Turkey
Health Sciences University Samsun Training and Research Hospital, Cardiology Clinic
🇹🇷Samsun, İlkadım, Turkey
Ankara City Hospital, Cardiology Clinic
🇹🇷Ankara, Cankaya, Turkey
Istanbul Bezmialem Foundation University, Faculty of Medicine Hospital, Cardiology Clinic
🇹🇷Istanbul, Fatih, Turkey
Başkent University İzmir Zübeyde Hanım Practice and Research Hospital, Cardiology Clinic
🇹🇷İzmir, Karsiyaka, Turkey
Muğla Yücelen Ortaca Hospital, Cardiology Clinic
🇹🇷Muğla, Mentese, Turkey
Yozgat City Hospital, Cardiology Clinic
🇹🇷Yozgat, Merkez, Turkey
Çanakkale Mehmet Akif Ersoy State Hospital, Cardiology Clinic
🇹🇷Çanakkale, Merkez, Turkey
Eskisehir Umit Private Hospital, Cardiology Clinic
🇹🇷Eskişehir, Tepebaşı, Turkey
Istanbul Şişli Hamidiye Etfal Training and Research Hospital, Cardiology Clinic
🇹🇷Istanbul, Sisli, Turkey
Mersin City Training and Research Hospital, Cardiology Clinic
🇹🇷Mersin, Toroslar, Turkey
Adana City Training and Research Hospital, Cardiology Clinic
🇹🇷Adana, Yuregir, Turkey
Van Yüzüncü Yıl University, Dursun Odabaş Medical Center
🇹🇷Van, Tusba, Turkey
Başkent University Istanbul Health Practice and Research Center Hospital, Department of Cardiology
🇹🇷Istanbul, Uskudar, Turkey
Aksaray Üniversitesi Eğitim Araştırma Hastanesi
🇹🇷Aksaray, Turkey
Bayındır Söğütözü Hastanesi
🇹🇷Ankara, Turkey
Eskişehir Şehir Hastanesi
🇹🇷Eskişehir, Turkey
Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi
🇹🇷Istanbul, Turkey
Özel Giresun Ada Hastanesi
🇹🇷Giresun, Turkey
Erciyes Üniversitesi Tıp Fakültesi
🇹🇷Kayseri, Turkey
İstanbul Yedikule Göğüs Hastalıkları ve Göğüs Cerrahisi EAH
🇹🇷Istanbul, Turkey
Manisa Akhisar Mustafa Kirazoğlu Devlet Hastanesi
🇹🇷Manisa, Turkey