The first patients have been enrolled into the ELIMINATE-AF study, pharmaceutical company Daiichi Sankyo Europe GmbH has said.
The multinational, randomised phase 3b study will explore the safety and efficacy of the once-daily direct factor Xa-inhibitor edoxaban (LIXIANA) 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. Approximately 560 patients will be enrolled in ELIMINATE-AF from 75 clinical sites across Europe, Canada and Asia.
Stefan Hohnloser, MD, Professor of Medicine and Cardiology, Head, Department of Electrophysiology, Johann Wolfgang Goethe University in Frankfurt, Germany, and principal study investigator, said: “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.
“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.”
Hans J. Lanz, MD, Executive Director, Global Medical Affairs, Daiichi Sankyo, said: “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.
“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.”