Study Type
Interventional - Drug
completed
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 Design
Randomized, double-blind, placebo control trial.
NO. of Countries
37
NO. of Sites
489
NO. of Participants
3236
Study Period
2010 - 2011
Sponsor
Sanofi
Stuart Connolly
Stuart Connolly
Stuart Connolly is a Professor of Medicine at McMaster University and a cardiac electrophysiologist at Hamilton Health Sciences. He became a faculty member at McMaster University in 1983 and was awarded a full professorship in 1994. He was also appointed as the inaugural holder of the Salim Yusuf Chair in Cardiology at McMaster University.
He has published more than 270 scientific articles in the field, and is currently a member of the editorial boards for a number of prominent cardiology journals, including Heart, the American Heart Journal and the Journal of Pacing and Electrophysiology. His main research interests are focused on the evaluation of treatments for heart rhythm disorders. His academic career has been largely devoted to the design and execution of controlled clinical trials in this area.
He holds a Masters degree from Fordham University, New York, and an MD from McGill University in Montreal. He received his specialist training in cardiology at the University of Toronto and at Stanford University.
