Edoxaban Treatment in Routine Clinical Practice for Patients With Non-valvular Atrial Fibrillation (ETNA-AF-Hong Kong)
Study Details
Study Description
Brief Summary
In order to understand the risks and benefits of edoxaban use in a real-world clinical setting in the NVAF indication, Daiichi-Sankyo Hong Kong proposed this non-interventional study (NIS) to gain insight into the safety of edoxaban use in non-preselected patients with NVAF.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Detailed Description
Edoxaban was approved by the Pharmacy and Poisons Board in Hong Kong (date: 31 May 2016) 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, 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 proposed this non-interventional study (NIS) to gain insight into the safety of edoxaban use in non-preselected patients with NVAF.
Real world evidence from routine clinical practice using edoxaban up to 2 years will be collected and evaluated in approximately 200 patients, treated by specialized as well as non-specialized physicians in hospital centers.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Edoxaban NVAF Patients treated with Edoxaban |
Drug: Edoxaban
Edoxaban according to Package Information (Summary of Product Characteristics (SmPC)).
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Number of participants with real world safety events [2 years]
Secondary Outcome Measures
- Number of participants with patient relevant outcomes [2 years]
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
- Average duration of exposure to edoxaban [within 2 years]
- Number of participants compliant with edoxaban therapy [2 years]
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Prince of Wales Hospital (1082) | Hong Kong | Hong Kong | ||
| 2 | Prince of Wales Hospital (1083) | Hong Kong | Hong Kong | ||
| 3 | Queen Mary Hospital, Department of Cardiology (1801) | Hong Kong | Hong Kong | ||
| 4 | Queen Mary Hospital, Department of Neurology (1805) | Hong Kong | Hong Kong |
Sponsors and Collaborators
- Daiichi Sankyo Hong Kong Ltd., a Daiichi Sankyo Company
Investigators
- Study Director: Late Phase Operations Lead, Global Medical Affairs, Daiichi Sankyo, Inc.
- Study Chair: Study Project Manager, Daiichi Sankyo (Hong Kong), Ltd.
Study Documents (Full-Text)
None provided.More Information
Publications
- DU176b-C-A4012