Non-interventional study on Edoxaban treatment in routine clinical practice for patients with non valvular atrial fibrillation (ETNA-AF-Europe)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Effectiveness study (incl. comparative)

  Other
• If ‘other’, further details on the scope of the study:
  Patient reported outcome

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Non-interventional post-authorisation safety study

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  EDOXABAN TOSYLATE
• Medical condition to be studied:
  Atrial fibrillation

Population studied

• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Renal impaired

  Hepatic impaired
• Estimated number of subjects:
  13100

Study design details

• Main study objective:
  The primary objective of this study is to collect real-world safety data on bleeding events, drug related adverse events in AF patients treated with Edoxaban up to 4 years. Furthermore, subgroup analyses will be performed in predefined patient populations, such as patients with renal or hepatic impairment.
• Outcomes:
  Major bleeding events including intracranial haemorrhage, fatal bleeding events, clinically relevant non-major bleeding events, stroke, systemic embolic events, cardiovascular (CV) events leading to hospitalisation, CV mortality, all-cause mortalitySuspected Edoxaban related adverse events, To assess the effect of Edoxaban on patient relevant outcomes as strokes, systemic embolic events, major cardiovascular events, hospitalisations related to cardiovascular condition, persistence to therapy, patient/physician reported outcome, health care utilization and resource use
• Data analysis plan:
  Details of the data analysis strategy will be fully described in a Statistical Analysis Plan (SAP). Briefly, all collected variables will be used in the statistical analysis. Binary, categorical, and ordinal parameters will be summarised by means of absolute and percentage numbers within the various categories. Numerical data will be summarised by means of standard statistics. In addition, adequate graphs (eg bar charts, box-whisker plots) may be presented. Kaplan-Meier plots will be generated where applicable to characterize the risk over time for each outcome. The purpose of all analyses will not be confirmatory but purely descriptive/exploratory.