A comparison of the effectiveness and safety of direct oral anticoagulants versus warfarin in older patients with atrial fibrillation using the Clinical Practice Research Datalink

Study type

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

  RIVAROXABAN

  APIXABAN

  EDOXABAN
• Medical condition to be studied:
  Atrial fibrillation

Population studied

• Age groups:
  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  36000

Study design details

• Main study objective:
  To compare the safety and effectiveness of warfarin compared with direct oral anticoagulants when prescribed for stroke prevention in patients aged 75 and over with atrial fibrillation.
• Outcomes:
  Primary effectiveness outcome: Stroke Primary safety outcome: Major bleeding, Secondary safety outcomes: clinically relevant non-major bleeding, intracranial haemorrhage, gastrointestinal haemorrhage, myocardial infarction, and all cause mortality.
• Data analysis plan:
  Baseline characteristics will be reported for each group as percentages, means (standard deviation) or medians (interquartile range). G-estimation will be used to compare the failure time with warfarin and DOACs to each of the primary and secondary outcomes individually . The DOAC group will be compared to both a historical and contemporary warfarin group. Apixaban and rivaroxaban will also be compared to both warfarin groups separately.