- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03247569
Edoxaban Treatment in Routine Clinical Practice for Patients With Non-Valvular Atrial Fibrillation (NVAF)
Non-interventional Study on Edoxaban Treatment in Routine Clinical Practice for Patients With Non-valvular Atrial Fibrillation (ETNA-AF-Thailand)
Study Overview
Detailed Description
Edoxaban was recently approved by The Thai Food and Drug Administration (Thai FDA) (date: 2nd December 2016) for the prevention of stroke and systemic embolism in adult patients with NVAF with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, 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.
In order to understand the risks and benefits of edoxaban use in a real-world clinical setting in the NVAF indication, Daiichi-Sankyo Thailand proposed this non-interventional study (NIS) to gain insight into the safety (bleeding, liver adverse events, all-cause mortality and other adverse events) of edoxaban use in non-preselected patients with NVAF.
Real world evidence data of routine clinical practice use of edoxaban up to 2 years will be collected and evaluated in approximately 300 patients, treated by specialized as well as non-specialized physicians in hospital centres.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Bangkok, Thailand
- Bhumibol Adulyadej Hospital
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Bangkok, Thailand
- Bangkok Heart Hospital
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Chiang Mai, Thailand
- Maharaj Nakorn Chiang Mai Hospital
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Chiang Mai, Thailand
- Bangkok Hospital Chiang Mai
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Pathum Thani, Thailand
- Thammasat University Hospital
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Muang District
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Khon Kaen, Muang District, Thailand, 40002
- Srinagarind Hospital and Queen Sirikit Heart Center of the Northeast
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Primary strategy is to include only patients with NVAF who are to be treated with edoxaban according to Package Information (Summary of Product Characteristics (SmPC)). To ensure that the physician's prescribing behaviour will not be influenced, patients may only be included after the treating physician has made the clinical decision to prescribe edoxaban.
Patients must have provided written informed consent for participation in the study (ICF) and should not participate simultaneously in any interventional study.
Description
Inclusion Criteria:
- Is a NVAF-patient whose physician has made the clinical decision to prescribe edoxaban therapy according to Package Information
- Has provided written informed consent to participate in the study
Exclusion Criteria:
- Is participating in an interventional study
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Edoxaban
Patients treated with Edoxaban
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Edoxaban according to Package Information (Summary of Product Characteristics (SmPC)).
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of participants with real world safety events
Time Frame: 2 years
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2 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with patient relevant outcomes
Time Frame: 2 years
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Categories: Strokes (ischaemic and haemorrhagic), Systemic Embolic Events (SEE), Transient Ischemic Attack (TIA), Major Adverse Cardiovascular Events (MACE), Venous Thromboembolism (VTE), Acute Coronary Syndrome (ACS), Hospitalisations related to cardiovascular (CV) condition
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2 years
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Average duration of exposure to edoxaban
Time Frame: within 2 years
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within 2 years
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Number of participants compliant with edoxaban therapy
Time Frame: 2 years
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2 years
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Collaborators and Investigators
Investigators
- Study Director: Late Phase Operations Lead, Global Medical Affairs, Daiichi Sankyo (Thailand) Ltd., a Daiichi Sankyo Company
- Study Chair: Study Project Manager, Daiichi Sankyo (Thailand) Ltd., a Daiichi Sankyo Company
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DU176b-C-A4011
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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