A Post-marketing Retrospective nOn-interventional study using naTionwide registries and electronic medical records to investigate the real-life Effectiveness and major bleeding Complications of oral anTicoagulants in Norwegian non-valvular Atrial Fibrillation patients (PROTECT-AF)

Study type

• Study topic:
  Disease /health condition

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

  Effectiveness study (incl. comparative)
• 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:
  RIVAROXABAN

  APIXABAN

  DABIGATRAN

  WARFARIN
• Medical condition to be studied:
  Atrial fibrillation

Population studied

• Short description of the study population:
  The study population will comprise all adult OAC naïve NVAF patients in Norway who filled a prescription for an OAC (rivaroxaban, apixaban, dabigatran, warfarin) in the study period, defined as from 1 January 2014 to 30 June 2018 (or later depending on availability of data).
• Age groups:
  • 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:
  Atrial fibrillation patients
• Estimated number of subjects:
  70000

Study design details

• Main study objective:
  To assess the effectiveness and safety of NOACs vs. VKA in patients with non-valvular atrial fibrillation.
• Outcomes:
  - Ischemic stroke- Intracranial hemorrhage, - Overall stroke- Systemic embolism- Myocardial infarction- All-cause mortality- Major bleeding- Demographic characteristics- Clinical characteristics- Drug utilization patterns
• Data analysis plan:
  Descriptive statistics will be used to present the data where continuous variables will be summarized as mean, standard deviation, median, minimum and maximum. Categorical variables will be described by frequencies and related percentages. Summaries will be reported separately for the elderly +75 years (cohort 1 and 2) and patients with renal impairment (cohort 2). Annual frequency of different OAC treatment during the study period in addition to adherence to each NOACs (high, moderate, low, and poor) will be presented. Also a separate analysis will be done to characterize patients with NVAF who have not been treated with OAC.