Engage AF-TIMI 48

A Stroke Prevention in Nonvalvular Atrial
Fibrillation Trial1

Trial Results Highlights

ENGAGE AF-TIMI 48: the largest (n=21,105) and longest (1022 days, median follow-up duration of 2.8 years) comparative trial for stroke prevention in atrial fibrillation trial to date1,2


Trial Design1,3


Trial Overview1

    • Eligible patients were 21 years of age or older and had atrial fibrillation documented by means of an electrical tracing within the 12 months preceding randomisation and a CHADS2 score of ≥2
    • Key exclusion criteria were atrial fibrillation due to a reversible disorder; an estimated creatinine clearance of less than 30 mL per minute; a high risk of bleeding; use of dual antiplatelet therapy; moderate to severe mitral stenosis; other indications for anticoagulation therapy; acute coronary syndromes, coronary revascularisation, or stroke within 30 days before randomisation; and an inability to adhere to study procedures
    • Patients were followed for over 2 years, with only 1 patient lost to follow-up
    • Included a well-managed warfarin comparator, with patients in the therapeutic INR range of 2.0 to 3.0 for 68.4% of the time (median time in therapeutic range)

Patient Baseline Characteristics


The ENGAGE AF-TIMI 48 Trial included a high percentage of eligible patients who also had one or more comorbidities or other factors that increase stroke or bleeding risk.1

  • Patient baseline characteristics were well balanced across study arms1
  • Patients may have had one or more comorbidities or other factors that increase bleeding risk.(SEE GRAPHIC ABOVE)1


Results Across Doses and Subgroups1,3


In the ENGAGE AF-TIMI 48 Trial:


  • Efficacy was evaluated in major subpopulations, including eligible patients who had comorbidities and other risk factors1,2
  • Safety was evaluated in major subpopulations, including eligible patients with factors that increase bleeding risk