Randomised, parallel-group, multicentre, multinational phase 2 study comparing edoxaban, an oral factor Xa inhibitor, with warfarin for stroke prevention in patients with atrial fibrillation

• Published in: Thrombosis and haemostasis Vol. 104; no. 3; p. 633
• Main Authors: Weitz, Jeffrey I, Connolly, Stuart J, Patel, Indravadan, Salazar, Daniel, Rohatagi, Shashank, Mendell, Jeanne, Kastrissios, Helen, Jin, Jianqing, Kunitada, Satoshi
• Format: Journal Article
• Language: English
• Published: Germany 01.09.2010
• Subjects: Administration, Oral; Aged; Alanine Transaminase - blood; Anticoagulants - administration & dosage; Anticoagulants - adverse effects; Anticoagulants - pharmacokinetics; Aspartate Aminotransferases; Atrial Fibrillation - blood; Atrial Fibrillation - complications; Atrial Fibrillation - drug therapy; Bilirubin - blood; Biomarkers - blood; Blood Coagulation - drug effects; Double-Blind Method; Europe, Eastern; Factor Xa - metabolism; Factor Xa Inhibitors; Female; Fibrin Fibrinogen Degradation Products - metabolism; Hemorrhage - chemically induced; Humans; International Normalized Ratio; Male; Middle Aged; Pyridines - administration & dosage; Pyridines - adverse effects; Pyridines - pharmacokinetics; Stroke - blood; Stroke - etiology; Stroke - prevention & control; Thiazoles - administration & dosage; Thiazoles - adverse effects; Thiazoles - pharmacokinetics; Time Factors; Treatment Outcome; United States; Warfarin - administration & dosage; Warfarin - adverse effects; Warfarin - pharmacokinetics

The primary objective of this study was to compare the safety of four fixed-dose regimens of edoxaban with warfarin in patients with non-valvular atrial fibrillation (AF). In this 12-week, parallel-group, multicentre, multinational study, 1,146 patients with AF and risk of stroke were randomised to...