Conditions: Atrial Fibrillation Atrial Flutter
Keywords: Mortality, Hospitalization
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 4628
Healthy volunteers: no

Brief summary:
To assess the efficacy of dronedarone in preventing cardiovascular hospitalization or death from any cause in a population of high-risk patients with atrial fibrillation/atrial flutter (AF/AFL).

To assess that dronedarone is well tolerated in this population.

Detailed description:
This is a prospective, multinational, double-blind, randomized, multi-center, placebo-controlled, parallel-group trial evaluating the effects of dronedarone versus placebo (ratio 1:1) over a minimum treatment duration of 12 months and a mean follow-up duration of 1.75 years (in AF/AFL patients). Patients can be included in the study while in atrial fibrillation/flutter or in sinus rhythm if conversion has occurred either spontaneously or following a procedure such as electrical cardioversion (or overdrive pacing) or administration of an antiarrhythmic drug.After randomization all patients will be followed until the common study end date; the last patient included in the study will be followed for 1 year. Visits will be at baseline, after 7 days, after 14 days, after one month, after three months and then every three months until end of the study. At each visit patients will be asked for the occurrence of hospitalizations or other events since the last visit. The study will be monitored by an independent Data Monitoring Committee (DMC) for safety, tolerability and efficacy.

Arms:
arm 1: Dronedarone 400mg tablets twice daily (bid) arm 2: matching placebo tablets

Interventions: intervention 1: dronedarone (SR33589) intervention 2: placebo
Intervention descriptions: intervention 1: oral administration (tablets) intervention 2: oral administration (tablets)

Protocol document: