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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00489736
• Date of registration: 20/06/2007
• Prospective Registration: No
• Primary sponsor: Sanofi
• Public title: Efficacy & Safety of Dronedarone Versus Amiodarone for the Maintenance of Sinus Rhythm in Patients With Atrial Fibrillation DIONYSOS
• Scientific title: Randomized Double Blind Trial to Evaluate the Efficacy and Safety of Dronedarone (400mg BID) Versus Amiodarone (600mg Daily for 28 Days, Then 200mg Daily Thereafter) for at Least 6 Months for the Maintenance of Sinus Rhythm in Patients With Atrial Fibrillation (AF)
• Date of first enrolment: June 2007
• Target sample size: 504
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00489736
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Argentina, Australia, Austria, Belgium, Canada, Chile, China, Czech Republic, Estonia, Finland, France, Germany, Italy, Korea, Republic of, Mexico, Morocco, Netherlands, Poland, Russian Federation, Sweden, Tunisia, Turkey, United States

Contacts

• Name: International Clinical Development
• Affiliation: Sanofi

Key inclusion & exclusion criteria

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.



Age minimum: 21 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Atrial Fibrillation

Intervention(s)

Drug: dronedarone (SR33589)

Drug: amiodarone

Primary Outcome(s)

Treatment Failure [Time Frame: minimum study duration is 6 months (+10 days); maximum is 15 months]

Secondary Outcome(s)

Occurrence of the Main Safety Endpoint (MSE) Defined as Thyroid, Hepatic, Pulmonary, Neurological, Skin, Eye, or Gastrointestinal Specific Treatment Emergent Events or Premature Study Drug Discontinuation Following Any Adverse Event [Time Frame: minimum study duration is 6 months (+10 days); maximum is 15 months]

Secondary ID(s)

EFC4968

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 09/11/2009
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00489736