Edoxaban vs. Warfarin in Subjects Undergoing Cardioversion of Nonvalvular Atrial Fibrillation (NVAF)
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Intervention: Edoxaban; Warfarin; Enoxaparin
Intervention description: Edoxaban 30 mg tablets for oral administration; Warfarin tablet, 1.0 or 2.5 mg, for oral administration; Enoxaparin per label, at prescribed dose until PT INR at least 2.0
Intervention MeSH terms: Enoxaparin; Warfarin; Edoxaban
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 2199.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Nonvalvular atrial fibrillation (NVAF); anti-coagulant; warfarin; edoxaban; electrical cardioversion

Summary:

      The purpose of this study is to compare edoxaban to warfarin (with enoxaparin, if needed). It
      will see if edoxaban prevents stroke and other blood clotting problems as well and as safely
      as warfarin. People with atrial fibrillation (irregular heartbeat) might be able to join.
      Their doctors must plan to use shock to make their hearts beat normally. About 2200 people
      from different countries will join. They will have an equal chance of receiving either
      treatment. They are anticipated to be in the study for around 82 days. Tests will include
      physicals and finger-pricks. Participants will provide blood and urine samples.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has signed informed consent

          -  Is older than minimum legal adult age (country specific)

          -  Has had ongoing AF lasting at least 48 hrs but <= 12 months (with or without valvular
             heart disease)

          -  Has treatment plan that includes for electrical cardioversion

          -  Has NVAF or other specific valvular heart diseases (eg, mitral valve prolapse, mitral
             valve regurgitation, and aortic valve disease)

        Exclusion Criteria:

          -  Has AF that is transient or reversible

          -  Has contraindicated condition, ie, conditions considered to be formal indication for
             conventional anticoagulation

          -  Has a history of left atrial appendage (LAA) closure

          -  Has a known thrombus in LAA, the left atrial, left ventricle or aorta - or an
             intracardial mass

          -  Has had myocardial infarction (MI), stroke, acute coronary syndrome (ACS), or
             percutaneous coronary intervention (PCI) within the past 30 days

          -  Has any contraindication to anticoagulant agents

          -  Has had protocol-defined signs of bleeding or conditions associated with high risk of
             bleeding that would preclude participation

          -  Is receiving, or plans to receive during the study period, dual antiplatelet therapy
             (DAPT) or invasive procedures (other than routine endoscopy) in which bleeding would
             be anticipated

          -  Has received prohibited concomitant medication or therapy

          -  Has had protocol-defined signs of bleeding or high

          -  Has inadequate liver, kidney, and blood test results

          -  Received any investigational drug or device within the past 30 days or plans to during
             the study period

          -  Has reproductive potential and does not agree to take proper contraceptive measures

          -  Has active cancer requiring chemotherapy/radiation/major surgery within the next 3
             months

          -  Has significant active concurrent medical illness or infection or life expectancy less
             than 6 months

          -  In the opinion of the investigator, is unlikely to comply with the protocol or
             complete the study, has had drug or alcohol dependence within the past year, or has
             any other condition that might place the participant at increased risk of harm

          -  Is a participant in the United States after January 2015 with creatinine clearance
             (CrCL) greater than 95 mL/minute