optimal timing of dronedarone initiation after conversion in patients with persistent atrial fibrillation

Conditions: Atrial Fibrillation

Summary: primary objective: - evaluate the rate of atrial fibrillation (af) recurrences one month after randomization according to different timings of initiation of dronedarone. secondary objective: * evaluate the rate of af recurrences two months after randomization. * assess the safety of the change from amiodarone to dronedarone * assess dronedarone safety * explore dronedarone and its active metabolite plasma level (in a subset of countries) * explore potential pharmacokinetic (pk) interaction between dronedarone and amiodarone (in a subset of countries)


Eligibility criteria:
inclusion criteria: screening: * persistent af for more than 72 hours (documented by an ecg taken within the last 72 hours) for whom cardioversion, anti-arrhythmic treatment and anticoagulation treatment are indicated in the opinion of the investigator * naive of amiodarone treatment in the last three months * qtc bazett \< 500 ms on 12-lead ecg, * at least one cardiovascular risk factor (i.e. age \> 70, hypertension, diabetes, prior cerebrovascular disease or left atrial diameter \>= 50 mm randomization: * outpatient and inpatients (except patients hospitalized during screening period for sae) * sinus rhythm * effective oral anticoagulation verified by international normalized ratio/inr (target \> 2) * qtc bazett \< 500 ms and pr \< 280 ms on 12-lead ecg * completed treatment period with amiodarone (28 days ± 2 days) exclusion criteria: screening: * contraindication to oral anticoagulation * acute condition known to cause af * permanent af * paroxysmal af * bradycardia \< 50 bpm on the 12-lead ecg * clinically overt congestive heart failure: * with new york heart association (nyha) classes iii and iv heart failure * with lvef \< 35% * or nyha class ii with a recent decompensation requiring hospitalization or referral to a specialized heart failure clinic * or unstable hemodynamic conditions * severe hepatic impairment * previous treatment with class i or class iii anti-arrhythmic drugs (including sotalol) if taken less than one week * previous history of amiodarone intolerance or toxicity * any contraindication as per dronedarone and amiodarone labelling * wolff-parkinson-white syndrome * previous ablation for atrial fibrillation or any planned ablation in the next 2 months * contraindicated concomitant treatment: * potent cytochrome p450 (cyp3a4) inhibitors * use of drugs or herbal products that prolong the qt interval and known to increase the risk of torsades de pointes * class i or iii anti-arrhythmic drugs (including sotalol) randomization: * bradycardia \< 50 bpm on the 12-lead ecg * clinically overt congestive heart failure: * with new york heart association (nyha) classes iii and iv heart failure * with lvef \< 35% * or nyha class ii with a recent decompensation requiring hospitalization or referral to a specialized heart failure clinic * or unstable hemodynamic conditions * severe hepatic impairment * previous treatment with class i or class iii anti-arrhythmic drugs (including sotalol) if taken less than one week * patient in whom the following contraindicated concomitant treatment is mandatory: * potent cytochrome p450 (cyp3a4) inhibitors * use of drugs or herbal products that prolong the qt interval and known to increase the risk of torsades de pointes * class i or iii anti-arrhythmic drugs (including sotalol) the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.