Optimal Timing of Dronedarone Initiation After Conversion in Patients With Persistent Atrial Fibrillation (ARTEMIS Load)
Atrial Fibrillation
About this trial
This is an interventional treatment trial for Atrial Fibrillation
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.
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Group A
Group B
Group C
Amiodarone 600 mg daily for 1 week then 400 mg daily for 1 week then 200 mg daily for 2 weeks followed by dronedarone 400 mg twice daily for 8 weeks
Amiodarone 600 mg daily for 1 week then 400 mg daily for 1 week then 200 mg daily for 2 weeks. Two weeks wash-out followed by dronedarone 400 mg twice daily for 6 weeks
Amiodarone 600 mg daily for 1 week then 400 mg daily for 1 week then 200 mg daily for 2 weeks. Four weeks wash-out followed by dronedarone 400 mg twice daily for 4 weeks