Permanent Atrial fibriLLAtion outcome Study using Dronedarone on top of standard therapy
To demonstrate the efficacy of Dronedarone in preventing major cardiovascular events (stroke, systemic arterial embolism, MI or CV Death) or CV hospitalization or death from any cause in patients with permanent atrial fibrillation and additional risk factors.
To demonstrate the efficacy of Dronedarone in preventing cardiovascular death in this patient population and to assess that Dronedarone is well tolerated.
Randomized, double-blind, placebo control trial.
The first coprimary outcome was a composite of stroke, myocardial infarction, systemic embolism, or death from cardiovascular causes. The second coprimary outcome was unplanned hospitalization for a cardiovascular cause or death. Other outcomes were death from cardiovascular causes, death from arrhythmia, recurrent hospitalization for cardiovascular causes, total nights in the hospital for cardiovascular reasons, acute coronary syndrome, stroke or systemic embolism, hospitalization for heart failure or heart-failure episode without hospitalization, and death from any cause.
Elizabeth Holmes, Suzanne Bajkor