Clinical trial NCT04594915: Evaluation of Treatment Safety in Patients With Atrial Fibrillation on Edoxaban Therapy in Real-Life in Turkey
Official title: Evaluation of Treatment Safety in Patients With Atrial Fibrillation on Edoxaban Therapy in Real-Life in Turkey (ETAF-TR)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Keywords: Edoxaban
Atrial Fibrillation
Nonvalvular Atrial Fibrillation (NVAF)
Non-vitamin K Oral Anticoagulants (NOACs)
Real World Evidence (RWE)
Turkey
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
Collaborators: name: Daiichi Sankyo
First posted: 2020-10-20
Enrollment: 1053
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Atrial fibrillation patients aged 18 years or above who are currently using Edoxaban for prevention of stroke.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of patients with Overt bleeding following Edoxaban therapy in routine clinical practice in Turkey
timeFrame: From baseline up to 1 year post enrollment
Secondary outcomes:
measure: Number of Patients with Clinically relevant non-major bleeding following Edoxaban therapy in routine clinical practice in Turkey
timeFrame: From baseline up to 1 year post enrollment
measure: Number of Patients with Major bleeding following Edoxaban therapy in routine clinical practice in Turkey
timeFrame: From baseline up to 1 year post enrollment
measure: Number of Patients with Net Clinical Benefit following Edoxaban therapy in routine clinical practice in Turkey
timeFrame: From baseline up to 1 year post enrollment
measure: Number of Patients with Stroke, transient ischemic attack and systemic embolism following Edoxaban therapy in routine clinical practice in Turkey
timeFrame: From baseline up to 1 year post enrollment
measure: Number of Patients with Major Cardiovascular Events Following Edoxaban Therapy in Routine Clinical Practice in Turkey
timeFrame: From baseline up to 1 year post enrollment
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Başkent University Alanya Practice and Research Hospital, Cardiology Clinic
state: Alanya
city: Ordu
country: Turkey
facility: Ordu University Training and Research Hospital
state: Altinordu
city: İzmir
country: Turkey
facility: Dokuz Eylül University Research and Practice Hospital, Department of Cardiology
state: Balçova
city: İzmir
country: Turkey
facility: Ege University Hospital, Department of Cardiology
state: Bornova
city: Ankara
country: Turkey
facility: Ankara City Hospital, Cardiology Clinic
state: Cankaya
city: İzmir
country: Turkey
facility: Izmir Çiğli Regional Training Hospital, Cardiology Clinic
state: Cigli
city: Aydın
country: Turkey
facility: Aydın Adnan Menderes University Practice and Research Hospital, Department of Cardiology
state: Efeler
city: Aydın
country: Turkey
facility: Private Medinova Hospital, Cardiology Clinic
state: Efeler
city: Istanbul
country: Turkey
facility: Istanbul Bezmialem Foundation University, Faculty of Medicine Hospital, Cardiology Clinic
state: Fatih
city: Samsun
country: Turkey
facility: Health Sciences University Samsun Training and Research Hospital, Cardiology Clinic
state: İlkadım
city: İzmir
country: Turkey
facility: Başkent University İzmir Zübeyde Hanım Practice and Research Hospital, Cardiology Clinic
state: Karsiyaka
city: İzmir
country: Turkey
facility: Medical Park Izmir Hospital, Cardiology Clinic
state: Karsiyaka
city: Muğla
country: Turkey
facility: Muğla Sıtkı Koçman University Training and Research Hospital, Department of Cardiology
state: Mentese
city: Muğla
country: Turkey
facility: Muğla Yücelen Ortaca Hospital, Cardiology Clinic
state: Mentese
city: Balıkesir
country: Turkey
facility: Balıkesir University Health Practice and Research Hospital, Cardiology Clinic
state: Merkez
city: Tokat
country: Turkey
facility: Tokat Gaziosmanpaşa University, Health Research and Practice Center, Cardiology Department
state: Merkez
city: Yozgat
country: Turkey
facility: Yozgat City Hospital, Cardiology Clinic
state: Merkez
city: Çanakkale
country: Turkey
facility: Çanakkale Mehmet Akif Ersoy State Hospital, Cardiology Clinic
state: Merkez
city: Çanakkale
country: Turkey
facility: Çanakkale Onsekiz Mart University Health Application and Research Hospital, Department of Cardiology
state: Merkez
city: Bursa
country: Turkey
facility: Bursa City Hospital, Cardiology Clinic
state: Nilüfer
city: Konya
country: Turkey
facility: Konya Numune Hospital, Cardiology Clinic
state: Selcuklu
city: Istanbul
country: Turkey
facility: Istanbul Şişli Hamidiye Etfal Training and Research Hospital, Cardiology Clinic
state: Sisli
city: Eskişehir
country: Turkey
facility: Eskisehir Umit Private Hospital, Cardiology Clinic
state: Tepebaşı
city: Mersin
country: Turkey
facility: Mersin City Training and Research Hospital, Cardiology Clinic
state: Toroslar
city: Van
country: Turkey
facility: Van Yüzüncü Yıl University, Dursun Odabaş Medical Center
state: Tusba
city: Istanbul
country: Turkey
facility: Başkent University Istanbul Health Practice and Research Center Hospital, Department of Cardiology
state: Uskudar
city: Manisa
country: Turkey
facility: Manisa Celal Bayar University Hafsa Sultan Hospital, Department of Cardiology
state: Yunusemre
city: Adana
country: Turkey
facility: Adana City Training and Research Hospital, Cardiology Clinic
state: Yuregir
city: Aksaray
country: Turkey
facility: Aksaray Üniversitesi Eğitim Araştırma Hastanesi
city: Ankara
country: Turkey
facility: Ankara Üniversitesi Tıp Fakültesi
city: Ankara
country: Turkey
facility: Bayındır Söğütözü Hastanesi
city: Ankara
country: Turkey
facility: Medicana International Ankara Hastanesi
city: Ankara
country: Turkey
facility: Özel Koru Sincan Hastanesi
city: Eskişehir
country: Turkey
facility: Eskişehir Şehir Hastanesi
city: Gaziantep
country: Turkey
facility: Dr. Ersin Arslan Eğitim ve Araştırma Hastanesi
city: Giresun
country: Turkey
facility: Özel Giresun Ada Hastanesi
city: Istanbul
country: Turkey
facility: Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi
city: Istanbul
country: Turkey
facility: İstanbul Bahçelievler Devlet Hastanesi
city: Istanbul
country: Turkey
facility: İstanbul Kartal Koşuyolu Yüksek İhtisas EAH
city: Istanbul
country: Turkey
facility: İstanbul Mehmet Akif Ersoy Göğüs Kalp ve Damar Cerrahisi EAH
city: Istanbul
country: Turkey
facility: İstanbul Yedikule Göğüs Hastalıkları ve Göğüs Cerrahisi EAH
city: Kayseri
country: Turkey
facility: Erciyes Üniversitesi Tıp Fakültesi
city: Manisa
country: Turkey
facility: Manisa Akhisar Mustafa Kirazoğlu Devlet Hastanesi
city: Tekirdağ
country: Turkey
facility: Tekirdağ Şehir Hastanesi
city: Trabzon
country: Turkey
facility: Trabzon Ahi Evren Göğüs Kalp ve Damar Cerrahisi EAH
Study officials:
affiliation: Daiichi Sankyo Turkey, a Daiichi Sankyo Company
name: Clinical Director
role: STUDY_DIRECTOR
References:
citation: Onsel Turk U, Alioglu E, Mavioglu Z, Diker E, Ozpelit E, De Caterina R. Evaluation of Treatment Safety in Patients with Atrial Fibrillation on Edoxaban Therapy in Real-Life in Turkey Study: Design and Rationale. Turk Kardiyol Dern Ars. 2022 Mar 1;50(2):117-123. doi: 10.5543/tkda.2022.21065.