Edoxaban Treatment in Routine Clinical Practice for Patients With Atrial Fibrillation in Korea and Taiwan (ETNA-AF-KOR-TWN)
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|ClinicalTrials.gov Identifier: NCT02951039|
Recruitment Status : Active, not recruiting
First Posted : November 1, 2016
Last Update Posted : December 18, 2019
|Condition or disease||Intervention/treatment|
|Atrial Fibrillation||Drug: Edoxaban|
Edoxaban was approved by the Ministry of Food and Drug Safety (MFDS) in Korea (date: 25th, August 2015) for the reduction in the risk of stroke and systemic embolism in patients with NVAF, treatment of deep vein thrombosis (DVT) and pulmonary embolism. Edoxaban was approved by the Taiwan Food and Drug Administration (TFDA) in Taiwan (date: 24th, February, 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 at least 75 years, diabetes mellitus, prior stroke or transient ischemic attack (TIA), or treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), following 5 to 10 days of initial therapy with a parenteral anticoagulant.
Real world evidence data of routine clinical practice use of edoxaban up to two years will be collected and evaluated in approximately 2,500 patients, treated by specialized as well as non-specialized physicians in hospital centers.
|Study Type :||Observational|
|Actual Enrollment :||3008 participants|
|Official Title:||Non-Interventional Study on Edoxaban Treatment in Routine Clinical Practice for Patients With Non Valvular Atrial Fibrillation (NVAF)|
|Actual Study Start Date :||February 21, 2017|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
Patients with established NVAF treated with edoxaban according to package information. 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.
Prescribed according to approved label
Other Name: Lixiana
- Rate of Participants Experiencing Real-World Safety Data Events within 2 Years [ Time Frame: within 2 years ]Real-world safety data events include bleeding events (including intracranial haemorrhage), adverse events and mortality
- Rate of Participants with Patient Relevant Outcomes [ Time Frame: within 2 years ]Patient relevant outcomes include Strokes (ischaemic and haemorrhagic) , Systemic Embolic Events (SEE), Transient Ischemic Attack (TIA), Major Adverse Cardiovascular Events (MACE), Venous Thromboembolism (VTE), Acute Coronary Syndrome (ACS), and Hospitalisations related to a cardiovascular (CV) condition.
- Rate of Participants Compliant with Edoxaban Therapy [ Time Frame: 2 years ]Categories: Always, Almost Always, Most of the Time, Less than Half the Time, Unknown
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02951039
|Study Director:||Global Clinical Leader||Daiichi Sankyo, Inc.|