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

• Sponsor: Daiichi Sankyo Turkey, a Daiichi Sankyo Company (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04594915
• Collaborator: Daiichi Sankyo, Inc. (Industry)
• Enrollment: 1,053
• Locations: 45
• Anticipated Duration (Months): 32.5
• Patients Per Site: 23.4
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation	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 Design

• Study Type: Observational
• Actual Enrollment: 1053 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Evaluation of Treatment Safety in Patients With Atrial Fibrillation on Edoxaban Therapy in Real-Life in Turkey (ETAF-TR)
• Actual Study Start Date: Aug 14, 2020
• Anticipated Primary Completion Date: May 1, 2023
• Anticipated Study Completion Date: May 1, 2023

Arms and Interventions

Arm	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]).

Outcome Measures

Primary Outcome Measures

1. 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

1. 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).

2. 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).

3. 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).

4. 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).

5. 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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Başkent University Alanya Practice and Research Hospital, Cardiology Clinic	Antalya	Alanya	Turkey
2	Ordu University Training and Research Hospital	Ordu	Altinordu	Turkey
3	Dokuz Eylül University Research and Practice Hospital, Department of Cardiology	İzmir	Balçova	Turkey
4	Ege University Hospital, Department of Cardiology	İzmir	Bornova	Turkey
5	Ankara City Hospital, Cardiology Clinic	Ankara	Cankaya	Turkey
6	Izmir Çiğli Regional Training Hospital, Cardiology Clinic	İzmir	Cigli	Turkey
7	Aydın Adnan Menderes University Practice and Research Hospital, Department of Cardiology	Aydın	Efeler	Turkey
8	Private Medinova Hospital, Cardiology Clinic	Aydın	Efeler	Turkey
9	Istanbul Bezmialem Foundation University, Faculty of Medicine Hospital, Cardiology Clinic	Istanbul	Fatih	Turkey
10	Health Sciences University Samsun Training and Research Hospital, Cardiology Clinic	Samsun	İlkadım	Turkey
11	Başkent University İzmir Zübeyde Hanım Practice and Research Hospital, Cardiology Clinic	İzmir	Karsiyaka	Turkey
12	Medical Park Izmir Hospital, Cardiology Clinic	İzmir	Karsiyaka	Turkey
13	Muğla Sıtkı Koçman University Training and Research Hospital, Department of Cardiology	Muğla	Mentese	Turkey
14	Muğla Yücelen Ortaca Hospital, Cardiology Clinic	Muğla	Mentese	Turkey
15	Balıkesir University Health Practice and Research Hospital, Cardiology Clinic	Balıkesir	Merkez	Turkey
16	Tokat Gaziosmanpaşa University, Health Research and Practice Center, Cardiology Department	Tokat	Merkez	Turkey
17	Yozgat City Hospital, Cardiology Clinic	Yozgat	Merkez	Turkey
18	Çanakkale Mehmet Akif Ersoy State Hospital, Cardiology Clinic	Çanakkale	Merkez	Turkey
19	Çanakkale Onsekiz Mart University Health Application and Research Hospital, Department of Cardiology	Çanakkale	Merkez	Turkey
20	Bursa City Hospital, Cardiology Clinic	Bursa	Nilüfer	Turkey
21	Konya Numune Hospital, Cardiology Clinic	Konya	Selcuklu	Turkey
22	Istanbul Şişli Hamidiye Etfal Training and Research Hospital, Cardiology Clinic	Istanbul	Sisli	Turkey
23	Eskisehir Umit Private Hospital, Cardiology Clinic	Eskişehir	Tepebaşı	Turkey
24	Mersin City Training and Research Hospital, Cardiology Clinic	Mersin	Toroslar	Turkey
25	Van Yüzüncü Yıl University, Dursun Odabaş Medical Center	Van	Tusba	Turkey
26	Başkent University Istanbul Health Practice and Research Center Hospital, Department of Cardiology	Istanbul	Uskudar	Turkey
27	Manisa Celal Bayar University Hafsa Sultan Hospital, Department of Cardiology	Manisa	Yunusemre	Turkey
28	Adana City Training and Research Hospital, Cardiology Clinic	Adana	Yuregir	Turkey
29	Aksaray Üniversitesi Eğitim Araştırma Hastanesi	Aksaray		Turkey
30	Ankara Üniversitesi Tıp Fakültesi	Ankara		Turkey
31	Bayındır Söğütözü Hastanesi	Ankara		Turkey
32	Medicana International Ankara Hastanesi	Ankara		Turkey
33	Özel Koru Sincan Hastanesi	Ankara		Turkey
34	Eskişehir Şehir Hastanesi	Eskişehir		Turkey
35	Dr. Ersin Arslan Eğitim ve Araştırma Hastanesi	Gaziantep		Turkey
36	Özel Giresun Ada Hastanesi	Giresun		Turkey
37	Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi	Istanbul		Turkey
38	İstanbul Bahçelievler Devlet Hastanesi	Istanbul		Turkey
39	İstanbul Kartal Koşuyolu Yüksek İhtisas EAH	Istanbul		Turkey
40	İstanbul Mehmet Akif Ersoy Göğüs Kalp ve Damar Cerrahisi EAH	Istanbul		Turkey
41	İstanbul Yedikule Göğüs Hastalıkları ve Göğüs Cerrahisi EAH	Istanbul		Turkey
42	Erciyes Üniversitesi Tıp Fakültesi	Kayseri		Turkey
43	Manisa Akhisar Mustafa Kirazoğlu Devlet Hastanesi	Manisa		Turkey
44	Tekirdağ Şehir Hastanesi	Tekirdağ		Turkey
45	Trabzon Ahi Evren Göğüs Kalp ve Damar Cerrahisi EAH	Trabzon		Turkey

Sponsors and Collaborators

• Daiichi Sankyo Turkey, a Daiichi Sankyo Company
• Daiichi Sankyo, Inc.

Investigators

• Study Director: Clinical Director, Daiichi Sankyo Turkey, a Daiichi Sankyo Company

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Daiichi Sankyo Turkey, a Daiichi Sankyo Company
• ClinicalTrials.gov Identifier: NCT04594915
• Other Study ID Numbers: ETAF-TR-01
• First Posted: Oct 20, 2020
• Last Update Posted: May 25, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• 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
• Keywords provided by Daiichi Sankyo Turkey, a Daiichi Sankyo Company: Edoxaban; Atrial Fibrillation; Nonvalvular Atrial Fibrillation (NVAF); Non-vitamin K Oral Anticoagulants (NOACs); Real World Evidence (RWE); Turkey
• Additional relevant MeSH terms: Atrial Fibrillation; Edoxaban

Study Results

No Results Posted as of May 25, 2022