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

NCT ID: NCT04594915

Last Updated: 2023-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1053 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-14

Study Completion Date

2023-06-21

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Atrial Fibrillation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Study Group

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

Edoxaban

Intervention Type DRUG

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

Interventions

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Edoxaban

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Daiichi Sankyo

INDUSTRY

Sponsor Role collaborator

Daiichi Sankyo Turkey, a Daiichi Sankyo Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Director

Role: STUDY_DIRECTOR

Daiichi Sankyo Turkey, a Daiichi Sankyo Company

Locations

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Başkent University Alanya Practice and Research Hospital, Cardiology Clinic

Antalya, Alanya, Turkey (Türkiye)

Site Status

Ordu University Training and Research Hospital

Ordu, Altinordu, Turkey (Türkiye)

Site Status

Dokuz Eylül University Research and Practice Hospital, Department of Cardiology

Izmir, Balçova, Turkey (Türkiye)

Site Status

Ege University Hospital, Department of Cardiology

Izmir, Bornova, Turkey (Türkiye)

Site Status

Ankara City Hospital, Cardiology Clinic

Ankara, Cankaya, Turkey (Türkiye)

Site Status

Izmir Çiğli Regional Training Hospital, Cardiology Clinic

Izmir, Cigli, Turkey (Türkiye)

Site Status

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

Aydin, Efeler, Turkey (Türkiye)

Site Status

Private Medinova Hospital, Cardiology Clinic

Aydin, Efeler, Turkey (Türkiye)

Site Status

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

Istanbul, Fatih, Turkey (Türkiye)

Site Status

Health Sciences University Samsun Training and Research Hospital, Cardiology Clinic

Samsun, İlkadım, Turkey (Türkiye)

Site Status

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

Izmir, Karsiyaka, Turkey (Türkiye)

Site Status

Medical Park Izmir Hospital, Cardiology Clinic

Izmir, Karsiyaka, Turkey (Türkiye)

Site Status

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

Muğla, Mentese, Turkey (Türkiye)

Site Status

Muğla Yücelen Ortaca Hospital, Cardiology Clinic

Muğla, Mentese, Turkey (Türkiye)

Site Status

Balıkesir University Health Practice and Research Hospital, Cardiology Clinic

Balıkesir, Merkez, Turkey (Türkiye)

Site Status

Çanakkale Mehmet Akif Ersoy State Hospital, Cardiology Clinic

Çanakkale, Merkez, Turkey (Türkiye)

Site Status

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

Çanakkale, Merkez, Turkey (Türkiye)

Site Status

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

Tokat Province, Merkez, Turkey (Türkiye)

Site Status

Yozgat City Hospital, Cardiology Clinic

Yozgat, Merkez, Turkey (Türkiye)

Site Status

Bursa City Hospital, Cardiology Clinic

Bursa, Nilüfer, Turkey (Türkiye)

Site Status

Konya Numune Hospital, Cardiology Clinic

Konya, Selcuklu, Turkey (Türkiye)

Site Status

Istanbul Şişli Hamidiye Etfal Training and Research Hospital, Cardiology Clinic

Istanbul, Sisli, Turkey (Türkiye)

Site Status

Eskisehir Umit Private Hospital, Cardiology Clinic

Eskişehir, Tepebaşı, Turkey (Türkiye)

Site Status

Mersin City Training and Research Hospital, Cardiology Clinic

Mersin, Toroslar, Turkey (Türkiye)

Site Status

Van Yüzüncü Yıl University, Dursun Odabaş Medical Center

Van, Tusba, Turkey (Türkiye)

Site Status

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

Istanbul, Uskudar, Turkey (Türkiye)

Site Status

Manisa Celal Bayar University Hafsa Sultan Hospital, Department of Cardiology

Manisa, Yunusemre, Turkey (Türkiye)

Site Status

Adana City Training and Research Hospital, Cardiology Clinic

Adana, Yuregir, Turkey (Türkiye)

Site Status

Aksaray Üniversitesi Eğitim Araştırma Hastanesi

Aksaray, , Turkey (Türkiye)

Site Status

Ankara Üniversitesi Tıp Fakültesi

Ankara, , Turkey (Türkiye)

Site Status

Bayındır Söğütözü Hastanesi

Ankara, , Turkey (Türkiye)

Site Status

Medicana International Ankara Hastanesi

Ankara, , Turkey (Türkiye)

Site Status

Özel Koru Sincan Hastanesi

Ankara, , Turkey (Türkiye)

Site Status

Eskişehir Şehir Hastanesi

Eskişehir, , Turkey (Türkiye)

Site Status

Dr. Ersin Arslan Eğitim ve Araştırma Hastanesi

Gaziantep, , Turkey (Türkiye)

Site Status

Özel Giresun Ada Hastanesi

Giresun, , Turkey (Türkiye)

Site Status

Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi

Istanbul, , Turkey (Türkiye)

Site Status

İstanbul Bahçelievler Devlet Hastanesi

Istanbul, , Turkey (Türkiye)

Site Status

İstanbul Kartal Koşuyolu Yüksek İhtisas EAH

Istanbul, , Turkey (Türkiye)

Site Status

İstanbul Mehmet Akif Ersoy Göğüs Kalp ve Damar Cerrahisi EAH

Istanbul, , Turkey (Türkiye)

Site Status

İstanbul Yedikule Göğüs Hastalıkları ve Göğüs Cerrahisi EAH

Istanbul, , Turkey (Türkiye)

Site Status

Erciyes Üniversitesi Tıp Fakültesi

Kayseri, , Turkey (Türkiye)

Site Status

Manisa Akhisar Mustafa Kirazoğlu Devlet Hastanesi

Manisa, , Turkey (Türkiye)

Site Status

Tekirdağ Şehir Hastanesi

Tekirdağ, , Turkey (Türkiye)

Site Status

Trabzon Ahi Evren Göğüs Kalp ve Damar Cerrahisi EAH

Trabzon, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type DERIVED
PMID: 35400633 (View on PubMed)

Other Identifiers

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ETAF-TR-01

Identifier Type: -

Identifier Source: org_study_id

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