Edoxaban Treatment in Routine Clinical Practice for Patients With Non-Valvular Atrial Fibrillation (NVAF)
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 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Edoxaban 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 | Srinagarind Hospital and Queen Sirikit Heart Center of the Northeast | Khon Kaen | Muang District | Thailand | 40002 |
| 2 | Bangkok Heart Hospital | Bangkok | Thailand | ||
| 3 | Bhumibol Adulyadej Hospital | Bangkok | Thailand | ||
| 4 | Bangkok Hospital Chiang Mai | Chiang Mai | Thailand | ||
| 5 | Maharaj Nakorn Chiang Mai Hospital | Chiang Mai | Thailand | ||
| 6 | Thammasat University Hospital | Pathum Thani | Thailand |
Sponsors and Collaborators
- Daiichi Sankyo (Thailand) Ltd., a Daiichi Sankyo Company
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
Study Documents (Full-Text)
None provided.More Information
Publications
- DU176b-C-A4011