The objective of the PALLAS study was 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, as well as to assess that Dronedarone is well tolerated.

First co-primary outcome:

Composite of stroke, myocardial infarction, systemic embolism, or death from cardiovascular causes.

Second co-primary outcome:

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.

Study Type

Interventional - Drug

Study Design

Randomized, double-blind, placebo control trial.

NO. of Countries


NO. of Sites


NO. of Participants


Study Period

2010 - 2011



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