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

NCT04594915 | Completed FDA Drug

• 1 other identifier: ETAF-TR-01
• Study Type: observational
• Target: 1,053
• Locations: 1 country
• Sites: 45

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.

Conditions

Atrial Fibrillation

Keywords

Edoxaban; Atrial Fibrillation; Nonvalvular Atrial Fibrillation (NVAF); Non-vitamin K Oral Anticoagulants (NOACs); Real World Evidence (RWE); Turkey

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

• Number of Patients with Major bleeding following Edoxaban therapy in routine clinical practice in Turkey

  From baseline up to 1 year post enrollment

• Number of Patients with Net Clinical Benefit following Edoxaban therapy in routine clinical practice in Turkey

  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

  From baseline up to 1 year post enrollment

• Number of Patients with Major Cardiovascular Events Following Edoxaban Therapy in Routine Clinical Practice in Turkey

  From baseline up to 1 year post enrollment

Study Arms (1)

Study Group

Patients diagnosed with AF who are currently using Edoxaban for stroke prevention in Turkey.

Drug: Edoxaban

Interventions

Edoxaban DRUG

Edoxaban according to Package Information (Summary of Product Characteristics \[SmPC\]).

Study Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Daiichi Sankyo Turkey, a Daiichi Sankyo Company: lead
• Daiichi Sankyo: collaborator

Study Sites (45)

Başkent University Alanya Practice and Research Hospital, Cardiology Clinic

Antalya, Alanya, Turkey (Türkiye)

Location

Ordu University Training and Research Hospital

Ordu, Altinordu, Turkey (Türkiye)

Location

Dokuz Eylül University Research and Practice Hospital, Department of Cardiology

Izmir, Balçova, Turkey (Türkiye)

Location

Ege University Hospital, Department of Cardiology

Izmir, Bornova, Turkey (Türkiye)

Location

Ankara City Hospital, Cardiology Clinic

Ankara, Cankaya, Turkey (Türkiye)

Location

Izmir Çiğli Regional Training Hospital, Cardiology Clinic

Izmir, Cigli, Turkey (Türkiye)

Location

Aydın Adnan Menderes University Practice and Research Hospital, Department of Cardiology

Aydin, Efeler, Turkey (Türkiye)

Location

Private Medinova Hospital, Cardiology Clinic

Aydin, Efeler, Turkey (Türkiye)

Location

Istanbul Bezmialem Foundation University, Faculty of Medicine Hospital, Cardiology Clinic

Istanbul, Fatih, Turkey (Türkiye)

Location

Health Sciences University Samsun Training and Research Hospital, Cardiology Clinic

Samsun, İlkadım, Turkey (Türkiye)

Location

Başkent University İzmir Zübeyde Hanım Practice and Research Hospital, Cardiology Clinic

Izmir, Karsiyaka, Turkey (Türkiye)

Location

Medical Park Izmir Hospital, Cardiology Clinic

Izmir, Karsiyaka, Turkey (Türkiye)

Location

Muğla Sıtkı Koçman University Training and Research Hospital, Department of Cardiology

Muğla, Mentese, Turkey (Türkiye)

Location

Muğla Yücelen Ortaca Hospital, Cardiology Clinic

Muğla, Mentese, Turkey (Türkiye)

Location

Balıkesir University Health Practice and Research Hospital, Cardiology Clinic

Balıkesir, Merkez, Turkey (Türkiye)

Location

Çanakkale Mehmet Akif Ersoy State Hospital, Cardiology Clinic

Çanakkale, Merkez, Turkey (Türkiye)

Location

Çanakkale Onsekiz Mart University Health Application and Research Hospital, Department of Cardiology

Çanakkale, Merkez, Turkey (Türkiye)

Location

Tokat Gaziosmanpaşa University, Health Research and Practice Center, Cardiology Department

Tokat Province, Merkez, Turkey (Türkiye)

Location

Yozgat City Hospital, Cardiology Clinic

Yozgat, Merkez, Turkey (Türkiye)

Location

Bursa City Hospital, Cardiology Clinic

Bursa, Nilüfer, Turkey (Türkiye)

Location

Konya Numune Hospital, Cardiology Clinic

Konya, Selcuklu, Turkey (Türkiye)

Location

Istanbul Şişli Hamidiye Etfal Training and Research Hospital, Cardiology Clinic

Istanbul, Sisli, Turkey (Türkiye)

Location

Eskisehir Umit Private Hospital, Cardiology Clinic

Eskişehir, Tepebaşı, Turkey (Türkiye)

Location

Mersin City Training and Research Hospital, Cardiology Clinic

Mersin, Toroslar, Turkey (Türkiye)

Location

Van Yüzüncü Yıl University, Dursun Odabaş Medical Center

Van, Tusba, Turkey (Türkiye)

Location

Başkent University Istanbul Health Practice and Research Center Hospital, Department of Cardiology

Istanbul, Uskudar, Turkey (Türkiye)

Location

Manisa Celal Bayar University Hafsa Sultan Hospital, Department of Cardiology

Manisa, Yunusemre, Turkey (Türkiye)

Location

Adana City Training and Research Hospital, Cardiology Clinic

Adana, Yuregir, Turkey (Türkiye)

Location

Aksaray Üniversitesi Eğitim Araştırma Hastanesi

Aksaray, Turkey (Türkiye)

Location

Ankara Üniversitesi Tıp Fakültesi

Ankara, Turkey (Türkiye)

Location

Bayındır Söğütözü Hastanesi

Ankara, Turkey (Türkiye)

Location

Medicana International Ankara Hastanesi

Ankara, Turkey (Türkiye)

Location

Özel Koru Sincan Hastanesi

Ankara, Turkey (Türkiye)

Location

Eskişehir Şehir Hastanesi

Eskişehir, Turkey (Türkiye)

Location

Dr. Ersin Arslan Eğitim ve Araştırma Hastanesi

Gaziantep, Turkey (Türkiye)

Location

Özel Giresun Ada Hastanesi

Giresun, Turkey (Türkiye)

Location

Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi

Istanbul, Turkey (Türkiye)

Location

İstanbul Bahçelievler Devlet Hastanesi

Istanbul, Turkey (Türkiye)

Location

İstanbul Kartal Koşuyolu Yüksek İhtisas EAH

Istanbul, Turkey (Türkiye)

Location

İstanbul Mehmet Akif Ersoy Göğüs Kalp ve Damar Cerrahisi EAH

Istanbul, Turkey (Türkiye)

Location

İstanbul Yedikule Göğüs Hastalıkları ve Göğüs Cerrahisi EAH

Istanbul, Turkey (Türkiye)

Location

Erciyes Üniversitesi Tıp Fakültesi

Kayseri, Turkey (Türkiye)

Location

Manisa Akhisar Mustafa Kirazoğlu Devlet Hastanesi

Manisa, Turkey (Türkiye)

Location

Tekirdağ Şehir Hastanesi

Tekirdağ, Turkey (Türkiye)

Location

Trabzon Ahi Evren Göğüs Kalp ve Damar Cerrahisi EAH

Trabzon, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 35400633 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

edoxaban

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Clinical Director

  Daiichi Sankyo Turkey, a Daiichi Sankyo Company

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2020
• First Posted: October 20, 2020
• Study Start: August 14, 2020
• Primary Completion: June 21, 2023
• Study Completion: June 21, 2023
• Last Updated: July 3, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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.
• 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.

Locations

TU (45)