Clinical trial NCT03247569: Edoxaban Treatment in Routine Clinical Practice for Patients With Non-Valvular Atrial Fibrillation (NVAF)
Official title: Non-interventional Study on Edoxaban Treatment in Routine Clinical Practice for Patients With Non-valvular Atrial Fibrillation (ETNA-AF-Thailand)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Keywords: Non-valvular Atrial Fibrillation
Real World Evidence
Observational Safety
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2017-08-11
Enrollment: 300
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 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.

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: Khon Kaen
country: Thailand
facility: Srinagarind Hospital and Queen Sirikit Heart Center of the Northeast
state: Muang District
city: Bangkok
country: Thailand
facility: Bangkok Heart Hospital
city: Bangkok
country: Thailand
facility: Bhumibol Adulyadej Hospital
city: Chiang Mai
country: Thailand
facility: Bangkok Hospital Chiang Mai
city: Chiang Mai
country: Thailand
facility: Maharaj Nakorn Chiang Mai Hospital
city: Pathum Thani
country: Thailand
facility: Thammasat University Hospital
Study officials:
affiliation: Daiichi Sankyo (Thailand) Ltd., a Daiichi Sankyo Company
name: Late Phase Operations Lead, Global Medical Affairs
role: STUDY_DIRECTOR
affiliation: Daiichi Sankyo (Thailand) Ltd., a Daiichi Sankyo Company
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.