Efficacy & Safety of Dronedarone Versus Amiodarone for the Maintenance of Sinus Rhythm in Patients With Atrial Fibrillation (DIONYSOS)

Sanofi

Status and phase: Completed; Phase 3

Conditions: Atrial Fibrillation

Treatments: Drug: amiodarone; Drug: dronedarone (SR33589)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00489736

EFC4968

Details and patient eligibility

About

The objective of this study is to compare the efficacy and safety of dronedarone to that of amiodarone for the treatment of patients with atrial fibrillation.

Enrollment: 504 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with documented atrial fibrillation for more than 72 hours for whom cardioversion and antiarrhythmic treatment is indicated in the opinion of the investigator and under oral anticoagulation

Exclusion criteria

• 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)
• Patients known to have chronic AF, patients with atrial flutter or paroxysmal atrial fibrillation
• Severe congestive heart failure with New-York Heart Association (NYHA) class III or IV, severe bradycardia, high degree atrio-ventricular block, ongoing potentially dangerous symptoms when in AF such as angina pectoris, transient ischemic attacks, stroke, syncope, as judged by the investigator, first degree family history of sudden cardiac death below age 50 years in the absence of coronary heart disease, significant sinus node disease without a permanent pacemaker implanted
• History of torsades de pointes or long QT syndrome or QT- or QTc-interval ≥500 msecs before randomization
• Treatment with other class I or III antiarrhythmic drugs which cannot be discontinued
• Dysthyroidism or other contraindication to amiodarone

The above information are not intended to contain all the considerations relevant to a patient's potential participation in a clinical trial.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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504 participants in 2 patient groups

Dronedarone 400mg bid

Experimental group

Description:

dronedarone 400mg tablets administered twice a day (bid) and matching over-encapsulated tablets of placebo of amiodarone 200mg

Treatment:

Drug: dronedarone (SR33589)

Amiodarone 600mg/200mg od

Active Comparator group

Description:

over-encapsulated tablets of amiodarone 200mg (600mg daily for 28 days then 200mg daily) administered once daily (od) and matching placebo of dronedarone 400mg tablets

Treatment:

Drug: amiodarone