Randomized double blind trial to evaluate the efficacy and safety of dronedarone (400 mg BID) versus amiodarone (600 mg daily for 28 days then 200 mg daily thereafter) for at least 6 months for the maintenance of sinus rhythm in patients with atrial fibrillation (AF)
- Conditions
- atrial fibrillation10007521
- Registration Number
- NL-OMON31364
- Lead Sponsor
- Sanofi-aventis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 40
- Patients with documented AF for more than 72 hours for whom cardioversion and antiarrhythmic treatment is indicated in the opinion of the Investigator and receiving anticoagulants,
- Signed informed consent for the study.
- Patients aged below 21 years,
- Contraindication to oral anticoagulation,
- Patient having received amiodarone in the past whatever the date (more than a total of twenty 200 mg tablets or more than 5 days intravenous [IV]),
- Women of childbearing potential without adequate birthcontrol; pregnant women; breastfeeding women,
- Clinically relevant haematologic, hepatic, gastrointestinal, renal, pulmonary, endocrinologic, psychiatric, neurological or dermatological disease,
- Serum potassium < 3.5 mmol/l and uncorrected or > 5.5 mmol/l before randomization,
- History of torsades de pointes; first degree family history of sudden cardiac death below age 50 years in the absence of coronary heart disease,
- History of high degree atrio-ventricular block (2nd degree Mobitz 2 or higher), or significant sinus node disease (documented pause of 3 sec or more) without a permanent pacemaker implanted,
- Bradycardia < 50 beats per minute (bpm) on the last 12-lead electrocardiogram (ECG) before randomization,
- Clinically overt congestive heart failure with NYHA class III or IV at the time of randomization,
- Ongoing potentially dangerous symptoms when in AF such as angina pectoris, transient ischemic attacks, stroke, syncope, as judged by the investigator,
- Patients known to have chronic AF defined as continuous AF for more than 12 months,
- Long QT syndrome or QT- or QTc-interval > or = 500 msecs before randomization,
- Wolff-Parkinson-White Syndrome,
- Patients with atrial flutter; patients with paroxysmal AF,
- Hyperthyroidism; hypothyroidism; other contraindications to amiodarone,
- Treatment with other Class I or III antiarrhythmic drugs.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Treatment failure defined as recurrence of AF or premature study drug<br /><br>discontinuation for intolerance or lack of efficacy.</p><br>
- Secondary Outcome Measures
Name Time Method <p>There are no secundary endpoints defined in the protocol.</p><br>