Edoxaban Treatment in Routine Clinical Practice for Patients With Non-Valvular Atrial Fibrillation (NVAF)

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-Thailand)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03247569
• Other study ID #: DU176b-C-A4011
• Status: Completed
• Start date: October 18, 2017
• Est. completion date: February 28, 2022

Study information

• Verified date: May 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: February 28, 2022
• Est. primary completion date: February 28, 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
Thailand	Bangkok Heart Hospital	Bangkok
Thailand	Bhumibol Adulyadej Hospital	Bangkok
Thailand	Bangkok Hospital Chiang Mai	Chiang Mai
Thailand	Maharaj Nakorn Chiang Mai Hospital	Chiang Mai
Thailand	Srinagarind Hospital and Queen Sirikit Heart Center of the Northeast	Khon Kaen	Muang District
Thailand	Thammasat University Hospital	Pathum Thani

Sponsors (1)

Lead Sponsor	Collaborator
Daiichi Sankyo (Thailand) Ltd., a Daiichi Sankyo Company

Country where clinical trial is conducted

Thailand, 

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