ELIMINATE-AF

A PROSPECTIVE, RANDOMIZED, OPEN-LABEL,BLINDED ENDPOINT EVALUATION (PROBE)PARALLEL GROUP STUDY COMPARING EDOXABANVS. VKA IN SUBJECTS UNDERGOING CATHETERABLATION OF NON-VALVULAR ATRIALFIBRILLATION (ELIMINATE-AF)

19/09/2017 to 31/12/2019

Primary efficacy objective: To compare descriptively the incidence of the composite of all-cause death, stroke (ischemic, hemorrhagic, or undetermined) and Major
Bleeding (International Society on Thrombosis and Hemostasis [ISTH] definition) in the edoxaban group against the vitamin K antagonist (VKA) group in subjects undergoing catheter ablation of atrial fibrillation (AF) in the period from the end of the catheter ablation procedure to Day 90/end-of-treatment (EOT).
Primary safety objective: To compare descriptively 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.
Secondary objectives: In subjects undergoing catheter ablation of AF, to compare descriptively the edoxaban group against the VKA group, with regards to the incidence of defined efficacy endpoints, and to compare descriptively the edoxaban group against the VKA group,
with regards to the incidence of defined safety endpoints