Edoxaban Treatment in Routine Clinical Practice for Patients With Non Valvular Atrial Fibrillation (ETNA-AF-EU)
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|ClinicalTrials.gov Identifier: NCT02944019|
Recruitment Status : Active, not recruiting
First Posted : October 25, 2016
Last Update Posted : December 24, 2018
|Condition or disease||Intervention/treatment|
|Atrial Fibrillation||Drug: Edoxaban|
|Study Type :||Observational|
|Actual Enrollment :||13980 participants|
|Official Title:||Non-Interventional Study on Edoxaban Treatment in Routine Clinical Practice for Patients With Non Valvular Atrial Fibrillation|
|Study Start Date :||August 2015|
|Estimated Primary Completion Date :||April 2022|
|Estimated Study Completion Date :||April 2023|
Patients with established Non Valvular Atrial Fibrillation (NVAF) treated with edoxaban according to Summary of Product Characteristics (SmPC). 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
- Percentage of Participants Experiencing Real-World Safety Data Events within 4 Years [ Time Frame: within 4 years ]Real-world safety data events include bleeding events including intracranial haemorrhage, drug related adverse events such as liver adverse events, cardiovascular (CV) and all-cause mortality
- Percentage of Participants with Patient Relevant Outcomes [ Time Frame: within 4 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 CV condition.
- Percentage of Participants Compliant with Edoxaban Therapy [ Time Frame: over 4 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): NCT02944019
|Study Director:||Global Clinical Leader||Daiichi Sankyo, Inc.|