Edoxaban Treatment in Routine Clinical Practice for Patients With Non-valvular Atrial Fibrillation (ETNA-AF-Hong Kong)

Atrial Fibrillation Clinical Trial

Official title:

Non-interventional Study on Edoxaban Treatment in Routine Clinical Practice for Patients With Non-valvular Atrial Fibrillation (ETNA-AF-Hong Kong)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03247582
• Other study ID #: DU176b-C-A4012
• Status: Completed
• Start date: August 2, 2017
• Est. completion date: May 3, 2022

Study information

• Verified date: August 2022
• Source: Daiichi Sankyo, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 234
• Est. completion date: May 3, 2022
• Est. primary completion date: May 3, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• Edoxaban
Edoxaban according to Package Information (Summary of Product Characteristics (SmPC)).

Locations

Country	Name	City	State
Hong Kong	Prince of Wales Hospital (1082)	Hong Kong
Hong Kong	Prince of Wales Hospital (1083)	Hong Kong
Hong Kong	Queen Mary Hospital, Department of Cardiology (1801)	Hong Kong
Hong Kong	Queen Mary Hospital, Department of Neurology (1805)	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Daiichi Sankyo Hong Kong Ltd., a Daiichi Sankyo Company

Country where clinical trial is conducted

Hong Kong, 

References & Publications (1)

Giugliano RP, Ruff CT, Braunwald E, Murphy SA, Wiviott SD, Halperin JL, Waldo AL, Ezekowitz MD, Weitz JI, Špinar J, Ruzyllo W, Ruda M, Koretsune Y, Betcher J, Shi M, Grip LT, Patel SP, Patel I, Hanyok JJ, Mercuri M, Antman EM; ENGAGE AF-TIMI 48 Investigators. Edoxaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2013 Nov 28;369(22):2093-104. doi: 10.1056/NEJMoa1310907. Epub 2013 Nov 19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with real world safety events		2 years
Secondary	Number of participants with patient relevant outcomes	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	2 years
Secondary	Average duration of exposure to edoxaban		within 2 years
Secondary	Number of participants compliant with edoxaban therapy		2 years