EFC11405 Clinical benefit of dronedarone in patients with permanent AF
Research type
Research Study
Full title
A randomized, double blind, placebo controlled, parallel group trial for assessing the clinical benefit of dronedarone 400mg BID in patients with permanent atrial fibrillation and additional risk factors. Permanent Atrial fibriLLAtion outcome Study using Dronedarone on top of standard therapy (PALLAS).
IRAS ID
43234
Contact name
Nicholas Peters
Sponsor organisation
Sanofi-aventis recherche & developpement
Eudract number
2010-019791-73
Clinicaltrials.gov Identifier
Research summary
Atrial fibrillation (AF) is a heart condition caused by faulty electrical messages in part of the heart (the atria) which causes it to beat in an irregular, rapid manner (arrhythmia). Having AF can increase the risk of people having strokes. This is because the irregular pumping of the heart increases the risk of blood clots forming in the heart. These blood clots can break free then get stuck in smaller blood vessels. When the blood clots are trapped in blood vessels that supply blood to the brain they cause a type of stroke called an ischaemic stroke. Other possible risks are worsening of angina (if this is a pre-existing condition) and heart failure.Anti-arrhythmia drugs help to regulate the heart beat and are often given to people with AF. Dronedarone is a new anti-arrhythmic drug similar to another anti-arrhythmic drug called amiodarone, but with less severe side effects. As well as its anti-arrhythmic properties it also slows heart rate, dilates blood vessels and reduces blood pressure. A previous study of dronedarone (ATHENA) in people with AF showed that dronedarone reduced their risk of cardiovascular hospitalisation or death. The ATHENA study was looking at people with particular types of AF, called paroxysmal or persistent AF, in which people are sometimes in a state of AF and sometimes in normal heart rhythm.There is another type of AF called permanent AF in which people are in a constant state of AF. Some people in the ATHENA study developed permanent AF during their participation. Analysis of the effect of dronedarone in this separate, smaller group of People'showed a consistent trend towards a reduced risk of cardiovascular hospitalisation or death.This study is designed to see whether dronedarone is effective in reducing the risk of these events in people with permanent AF.
REC name
London - Fulham Research Ethics Committee
REC reference
10/H0711/81
Date of REC Opinion
20 Oct 2010
REC opinion
Favourable Opinion