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

Completed

• Conditions: Atrial Fibrillation
• Interventions: Drug: Edoxaban

• Registration Number: NCT03247569
• Lead Sponsor: Daiichi Sankyo (Thailand) Ltd., a Daiichi Sankyo Company

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.

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 Timeline

• Study First Submitted: 2017-08-09
• Study First Submitted QC: 2017-08-09
• Study First Posted: 2017-08-11
• Study Start: 2017-10-18
• Primary Completion: 2022-02-28
• Study Completion: 2022-02-28
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-05
• Last Update Posted: 2022-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Edoxaban	Edoxaban	Patients treated with Edoxaban

Primary Outcome Measures

Name	Time	Method
Number of participants with real world safety events	2 years

Secondary Outcome Measures

Name	Time	Method
Average duration of exposure to edoxaban	within 2 years
Number of participants compliant with edoxaban therapy	2 years
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

Trial Locations

Locations (6)

Bangkok Heart Hospital; 🇹🇭 Bangkok, Thailand

Bhumibol Adulyadej Hospital; 🇹🇭 Bangkok, Thailand

Thammasat University Hospital; 🇹🇭 Pathum Thani, Thailand

Maharaj Nakorn Chiang Mai Hospital; 🇹🇭 Chiang Mai, Thailand

Srinagarind Hospital and Queen Sirikit Heart Center of the Northeast; 🇹🇭 Khon Kaen, Muang District, Thailand

Bangkok Hospital Chiang Mai; 🇹🇭 Chiang Mai, Thailand