English to Japanese Medical Medical: Cardiology

The active-comparator study recruited patients aged 21 years or older with documented AF for more than 72 hours, for whom cardioversion and anti-arrhythmic treatment were indicated and who were receiving oral anticoagulants. Patients with paroxysmal AF, AFL, severe congestive heart failure ((NYHA) class III or IV) were excluded. Patients were randomised to dronedarone 400 mg twice daily (n=249) or amiodarone 600 mg daily for 28 days then 200 mg daily (n=255) thereafter, for at least 6 months. The duration of follow-up was 6 months after the last patient was included and included scheduled and ***unscheduled ECGs***. The primary efficacy endpoint was defined as recurrence of AF or premature study drug discontinuation for intolerance or lack of efficacy.