Clinical trial NCT03247582: Edoxaban Treatment in Routine Clinical Practice for Patients With Non-valvular Atrial Fibrillation (ETNA-AF-Hong Kong)
Official title: Non-interventional Study on Edoxaban Treatment in Routine Clinical Practice for Patients With Non-valvular Atrial Fibrillation (ETNA-AF-Hong Kong)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Keywords: Real World Evidence
Non-valvular Atrial Fibrillation
Observational Safety
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2017-08-11
Enrollment: 234
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary strategy is to include only patients with NVAF who are to be treated with edoxaban according to Package Information (Summary of Product Characteristics (SmPC)). To ensure that the physician's prescribing behaviour will not be influenced, patients may only be included after the treating physician has made the clinical decision to prescribe edoxaban. Patients must have provided written informed consent for participation in the study (ICF) and should not participate simultaneously in any interventional study.

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.

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.

Eligibility 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

Primary outcomes:
measure: Number of participants with real world safety events
timeFrame: 2 years
Secondary outcomes:
measure: Number of participants with patient relevant outcomes
timeFrame: 2 years
measure: Average duration of exposure to edoxaban
timeFrame: within 2 years
measure: Number of participants compliant with edoxaban therapy
timeFrame: 2 years
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital (1082)
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital (1083)
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital, Department of Cardiology (1801)
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital, Department of Neurology (1805)
Study officials:
affiliation: Daiichi Sankyo
name: Late Phase Operations Lead, Global Medical Affairs
role: STUDY_DIRECTOR
affiliation: Daiichi Sankyo (Hong Kong), Ltd.
name: Study Project Manager
role: STUDY_CHAIR
References:
citation: Giugliano RP, Ruff CT, Braunwald E, Murphy SA, Wiviott SD, Halperin JL, Waldo AL, Ezekowitz MD, Weitz JI, Spinar 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.