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

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

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Drug: Edoxaban

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.

• Study Type: Observational
• Enrollment (Actual): 1053

Contacts and Locations

Study Locations

• Turkey
  • Aksaray, Turkey
    • Aksaray Üniversitesi Eğitim Araştırma Hastanesi
  • Ankara, Turkey
    • Ankara Üniversitesi Tıp Fakültesi
  • Ankara, Turkey
    • Bayındır Söğütözü Hastanesi
  • Ankara, Turkey
    • Medicana International Ankara Hastanesi
  • Ankara, Turkey
    • Özel Koru Sincan Hastanesi
  • Eskişehir, Turkey
    • Eskisehir Sehir Hastanesi
  • Gaziantep, Turkey
    • Dr. Ersin Arslan Eğitim ve Araştırma Hastanesi
  • Giresun, Turkey
    • Özel Giresun Ada Hastanesi
  • Istanbul, Turkey
    • Goztepe Prof. Dr. Suleyman Yalcın Sehir Hastanesi
  • Istanbul, Turkey
    • İstanbul Bahçelievler Devlet Hastanesi
  • Istanbul, Turkey
    • İstanbul Kartal Koşuyolu Yüksek İhtisas EAH
  • Istanbul, Turkey
    • İstanbul Mehmet Akif Ersoy Göğüs Kalp ve Damar Cerrahisi EAH
  • Istanbul, Turkey
    • İstanbul Yedikule Göğüs Hastalıkları ve Göğüs Cerrahisi EAH
  • Kayseri, Turkey
    • Erciyes Üniversitesi Tıp Fakültesi
  • Manisa, Turkey
    • Manisa Akhisar Mustafa Kirazoğlu Devlet Hastanesi
  • Tekirdağ, Turkey
    • Tekirdağ Şehir Hastanesi
  • Trabzon, Turkey
    • Trabzon Ahi Evren Göğüs Kalp ve Damar Cerrahisi EAH
  • Alanya
    • Antalya, Alanya, Turkey
      • Başkent University Alanya Practice and Research Hospital, Cardiology Clinic
  • Altinordu
    • Ordu, Altinordu, Turkey
      • Ordu University Training and Research Hospital
  • Balçova
    • İzmir, Balçova, Turkey
      • Dokuz Eylül University Research and Practice Hospital, Department of Cardiology
  • Bornova
    • İzmir, Bornova, Turkey
      • Ege University Hospital, Department of Cardiology
  • Cankaya
    • Ankara, Cankaya, Turkey
      • Ankara City Hospital, Cardiology Clinic
  • Cigli
    • İzmir, Cigli, Turkey
      • Izmir Çiğli Regional Training Hospital, Cardiology Clinic
  • Efeler
    • Aydın, Efeler, Turkey
      • Aydın Adnan Menderes University Practice and Research Hospital, Department of Cardiology
    • Aydın, Efeler, Turkey
      • Private Medinova Hospital, Cardiology Clinic
  • Fatih
    • Istanbul, Fatih, Turkey
      • Istanbul Bezmialem Foundation University, Faculty of Medicine Hospital, Cardiology Clinic
  • Karsiyaka
    • İzmir, Karsiyaka, Turkey
      • Başkent University İzmir Zübeyde Hanım Practice and Research Hospital, Cardiology Clinic
    • İzmir, Karsiyaka, Turkey
      • Medical Park Izmir Hospital, Cardiology Clinic
  • Mentese
    • Muğla, Mentese, Turkey
      • Muğla Sıtkı Koçman University Training and Research Hospital, Department of Cardiology
    • Muğla, Mentese, Turkey
      • Muğla Yücelen Ortaca Hospital, Cardiology Clinic
  • Merkez
    • Balıkesir, Merkez, Turkey
      • Balıkesir University Health Practice and Research Hospital, Cardiology Clinic
    • Tokat, Merkez, Turkey
      • Tokat Gaziosmanpaşa University, Health Research and Practice Center, Cardiology Department
    • Yozgat, Merkez, Turkey
      • Yozgat City Hospital, Cardiology Clinic
    • Çanakkale, Merkez, Turkey
      • Çanakkale Mehmet Akif Ersoy State Hospital, Cardiology Clinic
    • Çanakkale, Merkez, Turkey
      • Çanakkale Onsekiz Mart University Health Application and Research Hospital, Department of Cardiology
  • Nilüfer
    • Bursa, Nilüfer, Turkey
      • Bursa City Hospital, Cardiology Clinic
  • Selcuklu
    • Konya, Selcuklu, Turkey
      • Konya Numune Hospital, Cardiology Clinic
  • Sisli
    • Istanbul, Sisli, Turkey
      • Istanbul Şişli Hamidiye Etfal Training and Research Hospital, Cardiology Clinic
  • Tepebaşı
    • Eskişehir, Tepebaşı, Turkey
      • Eskisehir Umit Private Hospital, Cardiology Clinic
  • Toroslar
    • Mersin, Toroslar, Turkey
      • Mersin City Training and Research Hospital, Cardiology Clinic
  • Tusba
    • Van, Tusba, Turkey
      • Van Yüzüncü Yıl University, Dursun Odabaş Medical Center
  • Uskudar
    • Istanbul, Uskudar, Turkey
      • Başkent University Istanbul Health Practice and Research Center Hospital, Department of Cardiology
  • Yunusemre
    • Manisa, Yunusemre, Turkey
      • Manisa Celal Bayar University Hafsa Sultan Hospital, Department of Cardiology
  • Yuregir
    • Adana, Yuregir, Turkey
      • Adana City Training and Research Hospital, Cardiology Clinic
  • İlkadım
    • Samsun, İlkadım, Turkey
      • Health Sciences University Samsun Training and Research Hospital, Cardiology Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Atrial fibrillation patients aged 18 years or above who are currently using Edoxaban for prevention of stroke.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Study Group; Patients diagnosed with AF who are currently using Edoxaban for stroke prevention in Turkey.	Drug: Edoxaban; Edoxaban according to Package Information (Summary of Product Characteristics [SmPC]).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Daiichi Sankyo Turkey, a Daiichi Sankyo Company
• Collaborators: Daiichi Sankyo, Inc.
• Investigators: Study Director: Clinical Director, Daiichi Sankyo Turkey, a Daiichi Sankyo Company

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2020
• Primary Completion (Actual): June 21, 2023
• Study Completion (Actual): June 21, 2023

Study Registration Dates

• First Submitted: October 14, 2020
• First Submitted That Met QC Criteria: October 14, 2020
• First Posted (Actual): October 20, 2020

Study Record Updates

• Last Update Posted (Actual): July 3, 2023
• Last Update Submitted That Met QC Criteria: June 30, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Atrial Fibrillation; Turkey; Edoxaban; Nonvalvular Atrial Fibrillation (NVAF); Non-vitamin K Oral Anticoagulants (NOACs); Real World Evidence (RWE)
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Edoxaban
• Other Study ID Numbers: ETAF-TR-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
• IPD Sharing Time Frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
• IPD Sharing Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No