Atrial FibrillationETAF-TRNCT04594915
Evaluation of Treatment Safety in Patients With Atrial Fibrillation on Edoxaban Therapy in Real-Life in Turkey
An observational study of Atrial Fibrillation, run by Daiichi Sankyo Turkey, a Daiichi Sankyo Company at 45 sites in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Edoxaban
- How many people
- 1,053 participants
- Where
- 45 sitesTurkey (Türkiye)
- Study dates
- 14 Aug 2020to 21 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Atrial fibrillation patients aged 18 years or above who are currently using Edoxaban for prevention of stroke.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
45 sites in 1 country.
45 sites in 1 country
Turkey (Türkiye)45 sites
Adana City Training and Research Hospital, Cardiology Clinic
Adana, Yuregir
Aksaray Üniversitesi Eğitim Araştırma Hastanesi
Aksaray
Ankara City Hospital, Cardiology Clinic
Ankara, Cankaya
Ankara Üniversitesi Tıp Fakültesi
Ankara
Bayındır Söğütözü Hastanesi
Ankara
Medicana International Ankara Hastanesi
Ankara
Özel Koru Sincan Hastanesi
Ankara
Başkent University Alanya Practice and Research Hospital, Cardiology Clinic
Antalya, Alanya
Aydın Adnan Menderes University Practice and Research Hospital, Department of Cardiology
Aydin, Efeler
Private Medinova Hospital, Cardiology Clinic
Aydin, Efeler
Balıkesir University Health Practice and Research Hospital, Cardiology Clinic
Balıkesir, Merkez
Bursa City Hospital, Cardiology Clinic
Bursa, Nilüfer
Çanakkale Mehmet Akif Ersoy State Hospital, Cardiology Clinic
Çanakkale, Merkez
Çanakkale Onsekiz Mart University Health Application and Research Hospital, Department of Cardiology
Çanakkale, Merkez
Eskisehir Umit Private Hospital, Cardiology Clinic
Eskişehir, Tepebaşı
Eskişehir Şehir Hastanesi
Eskişehir
Dr. Ersin Arslan Eğitim ve Araştırma Hastanesi
Gaziantep
Özel Giresun Ada Hastanesi
Giresun
Istanbul Bezmialem Foundation University, Faculty of Medicine Hospital, Cardiology Clinic
Istanbul, Fatih
Istanbul Şişli Hamidiye Etfal Training and Research Hospital, Cardiology Clinic
Istanbul, Sisli
Başkent University Istanbul Health Practice and Research Center Hospital, Department of Cardiology
Istanbul, Uskudar
Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi
Istanbul
İstanbul Bahçelievler Devlet Hastanesi
Istanbul
İstanbul Kartal Koşuyolu Yüksek İhtisas EAH
Istanbul
İstanbul Mehmet Akif Ersoy Göğüs Kalp ve Damar Cerrahisi EAH
Istanbul
İstanbul Yedikule Göğüs Hastalıkları ve Göğüs Cerrahisi EAH
Istanbul
Dokuz Eylül University Research and Practice Hospital, Department of Cardiology
Izmir, Balçova
Ege University Hospital, Department of Cardiology
Izmir, Bornova
Izmir Çiğli Regional Training Hospital, Cardiology Clinic
Izmir, Cigli
Başkent University İzmir Zübeyde Hanım Practice and Research Hospital, Cardiology Clinic
Izmir, Karsiyaka
Medical Park Izmir Hospital, Cardiology Clinic
Izmir, Karsiyaka
Erciyes Üniversitesi Tıp Fakültesi
Kayseri
Konya Numune Hospital, Cardiology Clinic
Konya, Selcuklu
Manisa Celal Bayar University Hafsa Sultan Hospital, Department of Cardiology
Manisa, Yunusemre
Manisa Akhisar Mustafa Kirazoğlu Devlet Hastanesi
Manisa
Mersin City Training and Research Hospital, Cardiology Clinic
Mersin, Toroslar
Muğla Sıtkı Koçman University Training and Research Hospital, Department of Cardiology
Muğla, Mentese
Muğla Yücelen Ortaca Hospital, Cardiology Clinic
Muğla, Mentese
Ordu University Training and Research Hospital
Ordu, Altinordu
Health Sciences University Samsun Training and Research Hospital, Cardiology Clinic
Samsun, İlkadım
Tekirdağ Şehir Hastanesi
Tekirdağ
Tokat Gaziosmanpaşa University, Health Research and Practice Center, Cardiology Department
Tokat Province, Merkez
Trabzon Ahi Evren Göğüs Kalp ve Damar Cerrahisi EAH
Trabzon
Van Yüzüncü Yıl University, Dursun Odabaş Medical Center
Van, Tusba
Yozgat City Hospital, Cardiology Clinic
Yozgat, Merkez
About this study
Official title: 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.
Read the 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.
- Conditions
- Atrial Fibrillation
- Being tested
- Edoxaban
- Keywords
- Edoxaban, Atrial Fibrillation, Nonvalvular Atrial Fibrillation (NVAF), Non-vitamin K Oral Anticoagulants (NOACs), Real World Evidence (RWE), Turkey
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EdoxabanDrug
Edoxaban according to Package Information (Summary of Product Characteristics [SmPC]).
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Patients diagnosed with AF who are currently using Edoxaban for stroke prevention in Turkey. Receives: Drug: Edoxaban |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: From baseline up to 1 year post enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2020
- Study start14 Aug 2020
- Primary completion21 Jun 2023
- Study completion21 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,053 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo Turkey, a Daiichi Sankyo Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Daiichi Sankyo
- Responsible party
- Sponsor
- Investigators
- Clinical Director, Study director, Daiichi Sankyo Turkey, a Daiichi Sankyo Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04594915
- Sponsor's protocol ID
- ETAF-TR-01
- Acronym
- ETAF-TR
- Status last verified
- Jun 2023
- First submitted
- 14 Oct 2020
- Last updated
- 3 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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/
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.
PubMed 35400633
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Treatment Safety in Patients With Atrial Fibrillation on Edoxaban Therapy in Real-Life in Turkey (ETAF-TR)
- ClinicalTrials.gov ID
- NCT04594915
- Acronym / sponsor ID
- ETAF-TR / ETAF-TR-01
- Conditions
- Atrial Fibrillation
- Keywords
- Edoxaban, Atrial Fibrillation, Nonvalvular Atrial Fibrillation (NVAF), Non-vitamin K Oral Anticoagulants (NOACs), Real World Evidence (RWE), Turkey
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,053 participants (actual)
- Lead sponsor
- Daiichi Sankyo Turkey, a Daiichi Sankyo CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Daiichi Sankyo
- Study start
- 14 Aug 2020 (actual)
- Primary completion
- 21 Jun 2023 (actual)
- Study completion
- 21 Jun 2023 (actual)
- First posted
- 20 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | Drug: EdoxabanPatients diagnosed with AF who are currently using Edoxaban for stroke prevention in Turkey. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Atrial fibrillation patients aged 18 years or above who are currently using Edoxaban for prevention of stroke.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EdoxabanEdoxaban according to Package Information (Summary of Product Characteristics [SmPC]). | Drug | Study Group |
Primary outcome
Number of patients with Overt bleeding following Edoxaban therapy in routine clinical practice in Turkey
Time frame: 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).
5 secondary outcomes
Number of Patients with Clinically relevant non-major bleeding following Edoxaban therapy in routine clinical practice in Turkey
Time frame: From baseline up to 1 year post enrollment
Number of Patients with Major bleeding following Edoxaban therapy in routine clinical practice in Turkey
Time frame: From baseline up to 1 year post enrollment
Number of Patients with Net Clinical Benefit following Edoxaban therapy in routine clinical practice in Turkey
Time frame: 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
Time frame: From baseline up to 1 year post enrollment
Number of Patients with Major Cardiovascular Events Following Edoxaban Therapy in Routine Clinical Practice in Turkey
Time frame: From baseline up to 1 year post enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- Derived from this study: PubMed 35400633Onsel 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.
- Individual participant dataSharing planned: Yes. 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/
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Director study director
Daiichi Sankyo Turkey, a Daiichi Sankyo Company
45 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Daiichi Sankyo Turkey, a Daiichi Sankyo Company at 45 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with Overt bleeding following Edoxaban therapy in routine clinical practice in Turkey (time frame: From baseline up to 1 year post enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04594915, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2023.