Real-world evidence for non-valvular atrial fibrillation patients treated with oral anticoagulation in the Nordics (REATTAIN)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

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

  DABIGATRAN ETEXILATE

  RIVAROXABAN

  APIXABAN
• 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:
  70000

Study design details

• Main study objective:
  To describe the risk of ischemic stroke (IS)/systemic embolism (SE), and intracranial hemorrhage (ICH) in patients with NVAF initiating treatment with reduced doses of individual NOACs (rivaroxaban, apixaban, dabigatran) compared to VKA (warfarin)
• Outcomes:
  1. Number of participants with ischemic stroke (IS) or systemic embolism (SE), 2. Number of participants with intracranial haemorrhage (ICH)
• Data analysis plan:
  Risk of outcomes will be estimated by calculating cause-specific hazard ratios using Cox regression models