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)
Development and Validation of the DOAC Score – A Novel Bleeding Risk Prediction Tool for Patients with Atrial Fibrillation on Direct-Acting Oral Anticoagulants (Aggarwal, ESC 2023)
Efficacy and Safety of DOACs vs. Warfarin by Background Antiplatelet Therapy in 57,598 Patients With Atrial Fibrillation (Patel, ESC 2023)
OTHER PUBLICATIONS
Cardioversion of Atrial Fibrillation in ENGAGE AF-TIMI 48. Clin Cardiol. 2016 Jun;39(6):345-6.