At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Prospective, Randomized, Open-Label, Blinded Endpoint Evaluation (PROBE) Parallel Group Study Comparing Edoxaban vs. VKA in Subjects Undergoing Catheter Ablation of Non-valvular Atrial Fibrillation (ELIMINATE-AF)
In Brief
A Phase 3 clinical trial evaluating Edoxaban and VKA-Based Regimen for Atrial Fibrillation. Completed, enrolled 632 participants across 75 sites in 11 countries.
Detailed Summary
There are insufficient data on the safety and efficacy of edoxaban therapy in subjects with AF following catheter ablation. This phase 3b study is designed to evaluate the safety and to explore the efficacy of an edoxaban-based antithrombotic regimen versus a VKA-based antithrombotic regimen in subjects with AF following catheter ablation. Bleeding is a central safety outcome in cardiovascular clinical trials, especially for antithrombotic strategies and invasive procedures.
Study Details
Timeline
Interventions
Edoxaban 60 mg once-daily or 30 mg once-daily in selected subjects.
Dosed at International Normalised Ratio (INR) levels, which is a test of how long it takes for blood to clot. Standard of Care treatment in Canada, Italy, Poland, Hungary, Czech Republic, United Kingdom (UK), Taiwan and Korea.
Dosed at INR levels. Standard of Care treatment in Germany, Belgium, and the Netherlands.
Dosed at INR levels. Standard of Care treatment in France.
Dosed at INR levels. Standard of Care treatment in Spain.