Edoxaban Treatment in Routine Clinical Practice for Patients With Non-Valvular Atrial Fibrillation (NVAF)
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|ClinicalTrials.gov Identifier: NCT03247569|
Recruitment Status : Active, not recruiting
First Posted : August 11, 2017
Last Update Posted : December 18, 2019
|Condition or disease||Intervention/treatment|
|Atrial Fibrillation||Drug: Edoxaban|
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 Type :||Observational|
|Estimated Enrollment :||300 participants|
|Official Title:||Non-interventional Study on Edoxaban Treatment in Routine Clinical Practice for Patients With Non-valvular Atrial Fibrillation (ETNA-AF-Thailand)|
|Actual Study Start Date :||October 18, 2017|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
Patients treated with Edoxaban
Edoxaban according to Package Information (Summary of Product Characteristics (SmPC)).
Other Name: Lixiana
- Number of participants with real world safety events [ Time Frame: 2 years ]
- Number of participants with patient relevant outcomes [ Time Frame: 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
- Average duration of exposure to edoxaban [ Time Frame: within 2 years ]
- Number of participants compliant with edoxaban therapy [ Time Frame: 2 years ]
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): NCT03247569
|Srinagarind Hospital and Queen Sirikit Heart Center of the Northeast|
|Khon Kaen, Muang District, Thailand, 40002|
|Bangkok Heart Hospital|
|Bhumibol Adulyadej Hospital|
|Bangkok Hospital Chiang Mai|
|Chiang Mai, Thailand|
|Maharaj Nakorn Chiang Mai Hospital|
|Chiang Mai, Thailand|
|Thammasat University Hospital|
|Pathum Thani, Thailand|
|Study Director:||Late Phase Operations Lead, Global Medical Affairs||Daiichi Sankyo (Thailand) Ltd., a Daiichi Sankyo Company|
|Study Chair:||Study Project Manager||Daiichi Sankyo (Thailand) Ltd., a Daiichi Sankyo Company|