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Research

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PALLAS

Official Title

Permanent Atrial fibriLLAtion outcome Study using Dronedarone on top of standard therapy

Overview

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.

Study Design

Randomized, double-blind, placebo control trial.

Primary Endpoint

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.

Number of Patients

3236

Number of Sites

489

Number of Countries

37

Study Period

2010–2011

Principal Investigator

Stuart Connolly

Program Manager

Susan Chrolavicius

Research Coordinator

Elizabeth Holmes, Suzanne Bajkor

Collaborators

Sanofi-Aventis

Key Publications

  • Connolly SJ, Camm AJ, Halperin JL, Joyner C, Alings M, Amerena J, Atar D, Avezum Á, Blomström P, Borggrefe M, Budaj A, Chen SA, Ching CK, Commerford P, Dans A, Davy JM, Delacrétaz E, Di Pasquale G, Diaz R, Dorian P, Flaker G, Golitsyn S, Gonzalez-Hermosillo A, Granger CB, Heidbüchel H, Kautzner J, Kim JS, Lanas F, Lewis BS, Merino JL, Morillo C, Murin J, Narasimhan C, Paolasso E, Parkhomenko A, Peters NS, Sim KH, Stiles MK, Tanomsup S, Toivonen L, Tomcsányi J, Torp-Pedersen C, Tse HF, Vardas P, Vinereanu D, Xavier D, Zhu J, Zhu JR, Baret-Cormel L, Weinling E, Staiger C, Yusuf S, Chrolavicius S, Afzal R, Hohnloser SH; PALLAS Investigators. Dronedarone in high-risk permanent atrial fibrillation. N Engl J Med. 2011 Dec 15;365(24):2268-76. doi: 10.1056/NEJMoa1109867. Epub 2011 Nov 14. Erratum in: N Engl J Med. 2012 Feb 16;366(7):672.