Evaluation of Treatment Safety in Patients with Atrial Fibrillation on Edoxaban Therapy in Real-Life in Turkey Study: Design and Rationale

Evaluation of Treatment Safety in Patients with Atrial Fibrillation on Edoxaban Therapy in Real-Life in Turkey Study: Design and Rationale

Safety and effectiveness of edoxaban was demonstrated in phase III, Effective Anticoagulation with Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis in Myocardial Infarction 48 (ENGAGE-AF-TIMI 48) trial and is being confirmed in the post-authorization Edoxaban Treatment in routiNe clinic...

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Bibliographic Details
Published in:Turk Kardiyoloji Dernegi arsivi : Turk Kardiyoloji Derneginin yayin organidir Vol. 50; no. 2; p. 117
Main Authors: Önsel Türk, Uğur, Alioğlu, Emin, Mavioğlu, Zafer, Diker, Erdem, Özpelit, Ebru, De Caterina, Raffaele
Format: Journal Article
Language:English
Published: Turkey Aves Yayincilik Ltd. STI 01-03-2022
Subjects:
Anticoagulants - adverse effects
Atrial Fibrillation - chemically induced
Atrial Fibrillation - drug therapy
Cardiac arrhythmia
Clinical medicine
Factor Xa Inhibitors - adverse effects
Heart attacks
Humans
Prospective Studies
Pyridines
Stroke - drug therapy
Stroke - prevention & control
Thiazoles
Treatment Outcome
Turkey - epidemiology
Turkey
Europe
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Summary:Safety and effectiveness of edoxaban was demonstrated in phase III, Effective Anticoagulation with Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis in Myocardial Infarction 48 (ENGAGE-AF-TIMI 48) trial and is being confirmed in the post-authorization Edoxaban Treatment in routiNe clinical prActice for patients with Atrial Fibrillation in Europe (ETNA-AF-Europe) study in patients with atrial fibrillation. However, any post-authoriza tion safety study focusing on the safety of edoxaban treatment in Turkey with a prospective design has not been performed yet. The Evaluation of Treatment Safety in Patients with Atrial Fibrillation on Edoxaban Therapy in Real-Life in Turkey (ETAF-TR) study is designed to evaluate the safety and effectiveness of edoxaban treatment in atrial fibrillation in routine practice. The present article describes the design and rationale for the ETAF-TR Study. The ETAF-TR (NCT04594915) is a national, multicenter, prospective, observational study that enrolled 858 patients from 32 centers. The primary outcome of the ETAF-TR study is any overt bleeding (consisting of major bleeding or clinically relevant nonmajor bleeding or any bleeding that does not meet this definition but is considered as overt bleeding by the par ticipating physician). Effectiveness, treatment persistence, and posology will also be evaluated in an explorative manner. The overall duration of follow-up will be 1 year; the first patient was enrolled in August 2020. Results of ETAF-TR will add data from clinical practice to those from ENGAGE-AF trial and also ETNA-AF study. Comparing their results will enable to test the external validity of ENGAGE-AF trial in the country conditions.
ISSN:1016-5169
1308-4488
DOI:10.5543/tkda.2022.21065