Comparison of the length of stay in patients hospitalized and initiated with dabigatran or warfarin for a concomitant Non-Valvular Atrial Fibrillation in real-world Japanese therapeutic practice (SHORT-J Study)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

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

  WARFARIN POTASSIUM
• Medical condition to be studied:
  Atrial fibrillation

Population studied

• Short description of the study population:
  Patients hospitalized and initiated with dabigatran or warfarin for a concomitant Non-Valvular Atrial Fibrillation in real-world Japanese therapeutic practice.
• Age groups:
  • Paediatric Population (< 18 years)

    • Adolescents (12 to < 18 years)
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Patients with atrial fibrillation
• Estimated number of subjects:
  1600

Study design details

• Main study objective:
  The primary objective of this study is to compare the length of stay (LoS) of patients hospitalized and subsequently treated with dabigatran or warfarin for a non-valvular atrial fibrillation (NVAF) in a real-world Japanese therapeutic practice in patients with NVAF.
• Outcomes:
  The secondary objective of this study is to compare the LoS of patients hospitalized with 1) acute ischemic stroke, and 2) due to NVAF.
• Data analysis plan:
  Analyses of patient background data, LoS and cost information will be conducted using propensity score matching analysis. Differences of patient background data in dabigatran or warfarin users will be assessed using standardized difference and treatment effect of dabigatran against warfarin on LoS and cost will be assessed using confidence intervals as well as descriptive p-values.