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

Atrial Fibrillation Clinical Trial

— ETAF-TR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04594915
• Other study ID #: ETAF-TR-01
• Status: Completed
• Start date: August 14, 2020
• Est. completion date: June 21, 2023

Study information

• Verified date: June 2023
• Source: Daiichi Sankyo, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 1053
• Est. completion date: June 21, 2023
• Est. primary completion date: June 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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

Locations

Country	Name	City	State
Turkey	Adana City Training and Research Hospital, Cardiology Clinic	Adana	Yuregir
Turkey	Aksaray Üniversitesi Egitim Arastirma Hastanesi	Aksaray
Turkey	Ankara City Hospital, Cardiology Clinic	Ankara	Cankaya
Turkey	Ankara Üniversitesi Tip Fakültesi	Ankara
Turkey	Bayindir Sögütözü Hastanesi	Ankara
Turkey	Medicana International Ankara Hastanesi	Ankara
Turkey	Özel Koru Sincan Hastanesi	Ankara
Turkey	Baskent University Alanya Practice and Research Hospital, Cardiology Clinic	Antalya	Alanya
Turkey	Aydin Adnan Menderes University Practice and Research Hospital, Department of Cardiology	Aydin	Efeler
Turkey	Private Medinova Hospital, Cardiology Clinic	Aydin	Efeler
Turkey	Balikesir University Health Practice and Research Hospital, Cardiology Clinic	Balikesir	Merkez
Turkey	Bursa City Hospital, Cardiology Clinic	Bursa	Nilüfer
Turkey	Çanakkale Mehmet Akif Ersoy State Hospital, Cardiology Clinic	Çanakkale	Merkez
Turkey	Çanakkale Onsekiz Mart University Health Application and Research Hospital, Department of Cardiology	Çanakkale	Merkez
Turkey	Eskisehir Sehir Hastanesi	Eskisehir
Turkey	Eskisehir Umit Private Hospital, Cardiology Clinic	Eskisehir	Tepebasi
Turkey	Dr. Ersin Arslan Egitim ve Arastirma Hastanesi	Gaziantep
Turkey	Özel Giresun Ada Hastanesi	Giresun
Turkey	Baskent University Istanbul Health Practice and Research Center Hospital, Department of Cardiology	Istanbul	Uskudar
Turkey	Göztepe Prof. Dr. Süleyman Yalçin Sehir Hastanesi	Istanbul
Turkey	Istanbul Bahçelievler Devlet Hastanesi	Istanbul
Turkey	Istanbul Bezmialem Foundation University, Faculty of Medicine Hospital, Cardiology Clinic	Istanbul	Fatih
Turkey	Istanbul Kartal Kosuyolu Yüksek Ihtisas EAH	Istanbul
Turkey	Istanbul Mehmet Akif Ersoy Gögüs Kalp ve Damar Cerrahisi EAH	Istanbul
Turkey	Istanbul Sisli Hamidiye Etfal Training and Research Hospital, Cardiology Clinic	Istanbul	Sisli
Turkey	Istanbul Yedikule Gögüs Hastaliklari ve Gögüs Cerrahisi EAH	Istanbul
Turkey	Baskent University Izmir Zübeyde Hanim Practice and Research Hospital, Cardiology Clinic	Izmir	Karsiyaka
Turkey	Dokuz Eylül University Research and Practice Hospital, Department of Cardiology	Izmir	Balçova
Turkey	Ege University Hospital, Department of Cardiology	Izmir	Bornova
Turkey	Izmir Çigli Regional Training Hospital, Cardiology Clinic	Izmir	Cigli
Turkey	Medical Park Izmir Hospital, Cardiology Clinic	Izmir	Karsiyaka
Turkey	Erciyes Üniversitesi Tip Fakültesi	Kayseri
Turkey	Konya Numune Hospital, Cardiology Clinic	Konya	Selcuklu
Turkey	Manisa Akhisar Mustafa Kirazoglu Devlet Hastanesi	Manisa
Turkey	Manisa Celal Bayar University Hafsa Sultan Hospital, Department of Cardiology	Manisa	Yunusemre
Turkey	Mersin City Training and Research Hospital, Cardiology Clinic	Mersin	Toroslar
Turkey	Mugla Sitki Koçman University Training and Research Hospital, Department of Cardiology	Mugla	Mentese
Turkey	Mugla Yücelen Ortaca Hospital, Cardiology Clinic	Mugla	Mentese
Turkey	Ordu University Training and Research Hospital	Ordu	Altinordu
Turkey	Health Sciences University Samsun Training and Research Hospital, Cardiology Clinic	Samsun	Ilkadim
Turkey	Tekirdag Sehir Hastanesi	Tekirdag
Turkey	Tokat Gaziosmanpasa University, Health Research and Practice Center, Cardiology Department	Tokat	Merkez
Turkey	Trabzon Ahi Evren Gögüs Kalp ve Damar Cerrahisi EAH	Trabzon
Turkey	Van Yüzüncü Yil University, Dursun Odabas Medical Center	Van	Tusba
Turkey	Yozgat City Hospital, Cardiology Clinic	Yozgat	Merkez

Sponsors (2)

Lead Sponsor	Collaborator
Daiichi Sankyo Turkey, a Daiichi Sankyo Company	Daiichi Sankyo, Inc.

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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