The purpose of this study was to demonstrate the safety and efficacy profile, in two different dose regimens of DU-176b, (an investigational new drug being tested for the prevention of stroke/systemic embolic events (SEE)), in individuals with atrial fibrillation. Patients were randomized to one of three treatment groups: High Dose Regimen, Low Dose Regimen, & Warfarin.
MAIN RESULTS:
Edoxaban versus warfarin in patients with atrial fibrillation

N Engl J Med. 2013 Nov 28;369(22):2093-104.
PRESENTATIONS
TIMI 48 Slides
Relationship Between Edoxaban Dose, Concentration, Anti-Factor Xa Activity, and Outcomes in the ENGAGE AF-TIMI 48 Trial (Ruff, ESC 2014)
Biomarkers for the Assessment of Stroke-Systemic Embolism and Bleeding Risk in Patients with AF in ENGAGE (Berg, AHA 2018)
HF Hospitalization and Mortality in Non-Valvular AF (Inciardi, ESC 2019)
Edoxaban versus Warfarin in Atrial Fibrillation Patients with Low, Mid and High Body Weight in ENGAGE (Boriani, ESC 2019)
ENGAGE Genetics (Marston, AHA 2019)
A Targeted Proteomic Approach Identifies Novel Biomarkers of Arterial Thromboembolic Risk in ENGAGE AF-TIMI 48 (Berg, ACC 2021)
Epistaxis in Anticoagulated Patients with Atrial Fibrillation in the ENGAGE AF-TIMI 48 Trial (Semco, ESC 2021)
Effectiveness and Safety of Edoxaban in Atrial Fibrillation Patients from the ETNA-AF Global Registry (de Caterina, ESC 2021)
Evaluation of the ABC Pathway for Comprehensive Management of Atrial Fibrillation in 20,933 Patients from the ENGAGE AF-TIMI 48 Trial (Patel, AHA 2021)
A Genetic Risk Score to Predict Peripheral Artery Disease and Acute Limb Ischemia in Patients With Cardiometabolic Disease (Patel, AHA 2021)
Neutrophil-Lymphocyte Ratio and Outcomes in Patients with AF-Analyses from ENGAGE AF-TIMI 48 (Fagundes, ACC 2022)
Serial Assessment of Biomarkers and the Risk of Heart Failure in Patients (Oyama, ACC 2022) (with audio)
Safety and Efficacy of Non-Vitamin K Antagonist Oral Anticoagulants vs. Warfarin Across Body Mass Index and Body Weight – Insights from COMBINE-AF (Patel, AHA 2022)
Development of a Novel Polygenic Risk Score to Predict Risk of Aortic Stenosis Events (Small, AHA 2022)
Edoxaban 30mg vs Warfarin in 2,406 Patients Age 80 or Greater: A Randomized Analysis from ENGAGE-TIMI 48 (Zimerman, ACC 2023)
OTHER PUBLICATIONS
Cardioversion of Atrial Fibrillation in ENGAGE AF-TIMI 48. Clin Cardiol. 2016 Jun;39(6):345-6.