Edoxaban Treatment Versus Vitamin K Antagonist (VKA) in Patients With Atrial Fibrillation (AF) Undergoing Catheter Ablation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Intervention: Edoxaban; VKA-Based Regimen; VKA-Based Regimen; VKA-Based Regimen; VKA-Based Regimen
Intervention description: 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.
Intervention MeSH terms: Warfarin; Edoxaban; Acenocoumarol; Phenprocoumon; Fluindione
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 632.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female at least 18 years of age with documented history of paroxysmal (lasting
             ≤7 days), persistent (lasting >7 days but ≤12 months) or long-standing [long-lasting]
             persistent (>12 months) non-valvular AF. Duration of AF can be confirmed by any
             electrical tracing or a recording in the subject's medical records (e.g., medical
             chart, hospital discharge summary).

          -  Subject is eligible and is scheduled for either radio frequency (RF) or cryoballoon
             catheter ablation (both first and repeated procedure included).

          -  Signed informed consent form (ICF).

        Exclusion Criteria:

          -  AF considered to be of a transient or reversible nature (such as in myocarditis,
             post-surgery, ionic disturbances, thyrotoxicosis, pneumonia, severe anemia etc.).

          -  Subject post stroke, or with a systemic thromboembolic event within the past 6 months
             prior to randomization.

          -  Subject has a thrombus in the left atrial appendage (LAA), left atrium (LA), left
             ventricle (LV), or aorta, or an intracardial mass.

          -  Subject had a myocardial infarction (MI) within the 2 months prior to randomization or
             coronary artery bypass graft (CABG) surgery within 3 months prior to the
             randomization.

          -  Subject has signs of bleeding, history of clinically-relevant bleeding according to
             International Society on Thrombosis and Hemostasis (ISTH), or conditions associated
             with high risk of bleeding

          -  Subjects with any contraindication for anticoagulant agents.