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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) - DIONYSOS

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) - DIONYSOS

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2006-005804-15-AT
Enrollment
472
Registered
2007-04-23
Start date
2007-04-23
Completion date
Unknown
Last updated
2012-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation MedDRA version: 9.1 Level: LLT Classification code 10003658 Term: Atrial fibrillation

Interventions

Product Name: dronedarone Product Code: SR33589B Pharmaceutical Form: Film-coated tablet INN or Proposed INN: dronedarone CAS Number: 141625-93-6 Current Sponsor code: SR33589B Concentration unit: mg

Sponsors

sanofi-aventis recherche & développement
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - 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 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 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.

Design outcomes

Primary

MeasureTime frame
Main Objective: To demonstrate that dronedarone is superior to amiodarone in the maintenance of sinus rhythm after pharmacological, electrical or spontaneous conversion of AF.;Secondary Objective: To evaluate the safety of dronedarone versus amiodarone.;Primary end point(s): Treatment failure defined as recurrence of AF or premature study drug discontinuation for intolerance or lack of efficacy.—

Countries

Austria, Belgium, Czech Republic, Estonia, Finland, Germany, Italy, Netherlands, Poland, Sweden

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026