An observational study in Atrial Fibrillation, sponsored by Daiichi Sankyo Turkey, a Daiichi Sankyo Company. Completed at 45 sites in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-03.
Sponsored by Daiichi Sankyo Turkey, a Daiichi Sankyo Company · Observational
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:
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.
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's enrollment of 1,053 is above the median of 300 across 1,363 observational studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →This is the only study on the registry with Daiichi Sankyo Turkey, a Daiichi Sankyo Company as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Atrial fibrillation patients aged 18 years or above who are currently using Edoxaban for prevention of stroke.
Exclusion Criteria:
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 \[SmPC\]).
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).
Time frame: From baseline up to 1 year post enrollment
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).
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
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).
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
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).
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
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).
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
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).
Time frame: From baseline up to 1 year post enrollment
Plan to share: 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/
Supporting information: Study protocol, Sap, Icf
This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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