Conditions: Atrial Fibrillation
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 3236
Healthy volunteers: no

Brief summary:
Primary Objective:

* Demonstrate the efficacy of Dronedarone in preventing major cardiovascular events (stroke, systemic arterial embolism, myocardial infarction or cardiovascular death) or unplanned cardiovascular hospitalization or death from any cause in patients with permanent Atrial Fibrillation \[AF\] and additional risk factors

Secondary Objective:

* Demonstrate the efficacy of Dronedarone in preventing cardiovascular death

This was an event-driven study where a common study end date \[CSED\] was to be determined by Steering Committee based on the number of events (stroke, systemic arterial embolism, myocardial infarction or cardiovascular death).

Detailed description:
The study period per participant was variable depending on the enrollment in the study.

A final follow-up visit had to occur within 1 month after the CSED.

Arms:
arm 1: Dronedarone 400 mg twice a day until the CSED arm 2: Placebo (for Dronedarone) twice a day until the CSED

Interventions: intervention 1: Dronedarone intervention 2: Placebo (for Dronedarone)
Intervention descriptions: intervention 1: Film-coated tablet

Oral administration under fed conditions (during breakfast and dinner) intervention 2: film-coated tablet strictly identical in appearance

Oral administration under fed conditions (during breakfast and dinner)

Protocol document: