Daiichi Sankyo Company, Limited has announced that the first patient has been enrolled into the ELIMINATE-AF study. The multinational, randomized phase 3b study will explore the safety and efficacy of the company’s oral, once-daily direct factor Xa-inhibitor edoxaban (known by the brand name Lixiana outside the US and Savaysa in the US) against a vitamin K antagonist in patients with atrial fibrillation (AF) undergoing catheter ablation. The study will investigate the incidence of the composite of all-cause death, stroke and major bleeding (International Society on Thrombosis and Hemostasis [ISTH] definition). Approximately 560 patients will be enrolled in ELIMINATE-AF from 75 clinical sites across Europe, Canada and Asia.
“Catheter ablation as a method of treating AF is more frequently performed in clinical practice due to its positive effect on AF-related symptoms and quality of life; however, it is associated with a significant thromboembolic risk during and shortly after the procedure,” said Stefan Hohnloser, MD, Professor of Medicine and Cardiology, Head, Department of Electrophysiology, Johann Wolfgang Goethe University in Frankfurt, Germany, and principal study investigator. “ELIMINATE-AF will provide insights into the use of edoxaban for uninterrupted anticoagulation in patients undergoing catheter ablation, applying state-of-the-art treatment in accordance with the recent treatment guidelines. In this study, edoxaban will be used with the approved dosage regimen for stroke prevention in atrial fibrillation”
“Following the positive results of the use of edoxaban in the ENSURE-AF cardioversion study, we now look forward to evaluating the use of edoxaban in patients undergoing cardiac ablation with ELIMINATE-AF,” said Hans J. Lanz, MD, executive director, global medical affairs, Daiichi Sankyo. “Importantly, the study will add to the growing body of evidence in the Edoxaban Clinical Research Programme, and help to broaden clinicians’ understanding of the concept of uninterrupted anticoagulation for catheter ablation.”
EvaLuatIon of Edoxaban coMpared with VKA IN subjects undergoing cAThEter ablation of non-valvular Atrial Fibrillation(ELIMINATE-AF)is a prospective, randomized, open-label, blinded endpoint evaluation, parallel-group phase 3b study to evaluate the efficacy and safety of once-daily edoxaban against a vitamin K antagonist in AF patients undergoing catheter ablation of AF. The primary objective is to descriptively compare the incidence of the composite of all-cause death, stroke (ischemic, hemorrhagic, or undetermined) and major bleeding (ISTH definition) in the edoxaban group against the vitamin K antagonist group in the period from the end of the catheter ablation procedure to Day 90/end-of-treatment (EOT). The primary safety objective is to descriptively compare the incidence of major bleeding (ISTH definition) in the edoxaban group against the VKA group in the period from date of first intake of study medication to Day 90/EOT. Approximately 560 patients will be enrolled in ELIMINATE-AF from 75 clinical sites across Europe, Canada and Asia. Patients will be randomized to receive edoxaban or VKA for 21 days pre- and 90 days post-ablation period.