Medical Need of Non-vitamin K Oral Anti-coagulant Reversal in Japan: Epidemiological Assessment of Emergency Surgery, Trauma and Fracture, using Large Scale Claims Database

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  DABIGATRAN

  RIVAROXABAN

  EDOXABAN

  APIXABAN

  WARFARIN
• 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)
• Estimated number of subjects:
  62888

Study design details

• Main study objective:
  The primary objective of this study is to assess the incidence rates of emergency surgery and major bleeding associated with fracture and trauma. Secondary objective is to assess the incidence rates of cardiac tamponade and pericardiocentesis.A further objective is to describe the types of emergency surgeries identified
• Outcomes:
  For the primary objectiveIncidence rate (overall and age stratified) of emergency surgery and major bleeding due to fracture/trauma will be described with number of patients presenting the event, patient-years and 95% confidence interval overall and stratified by age. For the secondary objectiveIncidence rates (overall and age stratified) of cardiac tamponade and peri-cardiocentesis, along with number of events, patient year of follow-up not including time after switch, and 95% confidence interval. For the further objective
• Data analysis plan:
  Incidence of emergency surgery, major bleeding due to fracture and trauma during the on-treatment follow-up in the claims database with number of patients presenting the event, patient-years and 95% confidence interval overall and stratified by age.