Pharmacokinetics and Optimal Timing of Dronedarone Initiation Following Long-term Amiodarone in Patients With Paroxysmal or Persistent Atrial Fibrillation

Exclusion Criteria

• •Screening:
• •Contraindication to oral anticoagulation
• •Acute condition known to cause AF
• •Permanent AF
• •Bradycardia \< 50 bpm at rest on the 12-lead ECG
• •History of, or current heart failure or left ventricular systolic dysfunction
• •Unstable hemodynamic conditions
• •Severe hepatic impairment
• •Wolff-Parkinson-White Syndrome
• •Previous catheter ablation for atrial fibrillation or catheter ablation scheduled in the next 10 weeks
• •Previous history of Amiodarone intolerance or toxicity
• •History of thyroid dysfunction
• •Mandatory contraindicated concomitant treatment:
• •* potent cytochrome P450 (CYP3A4) inhibitors
• •* drugs or herbal products that prolong the QT interval and known to increase the risk of Torsade de Pointes
• •Previous treatment with class I or class III anti-arrhythmic drugs (including sotalol) other than amiodarone if the anti-arrhythmic drug was taken less than one week before the day of screening (if taken more than one week before screening, the patient can be included)
• •Randomization
• •Bradycardia \< 50 bpm on the 12-lead ECG
• •History of, or current heart failure or left ventricular systolic dysfunction
• •Unstable hemodynamic conditions
• •Severe hepatic impairment
• •Mandatory contraindicated concomitant treatment:
• •* potent cytochrome P450 (CYP3A4) inhibitors
• •* drugs or herbal products that prolong the QT interval and known to increase the risk of Torsade de Pointes
• •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.