ARTEMIS AF Loading

• Research type

  Research Study

• Full title

  A Randomized, international, multi-center, open-label study to document optimal timing of initiation of dronedarone TreatmEnt after conversion with loading dose of aMIodarone in patients with perSistent Atrial Fibrillation requiring conversion of AF.

• IRAS ID

  36982

• Contact name

  John P M Foran

• Sponsor organisation

  Aventis Pharma Ltd trading as sanofi−aventis

• Eudract number

  2009-016818-24

• ISRCTN Number

  N/A

• Research summary

  The aim of this study is to generate data so clear guidance can be provided to doctors on the safest and most effective way of changing a patient from amiodarone onto dronedarone. This will be assessed by looking at rate of Atrial Fibrillation (AF) recurrence in the groups taking dronedarone at different time points. AF is a common disease in which the heart’s rhythm is abnormal, resulting in irregular and rapid heartbeats. This abnormality is caused by a disturbance of the electrical system that controls the heart’s contraction. Physicians may try to reestablish and maintain normal heart rhythm (a process called cardioversion) either by antiarrhythmic drugs, such as amiodarone (pharmacologic cardioversion) or if not sufficient, by an electrical cardioversion. Although it is the most effective antiarrhythmic drug, long term use of amiodarone is hampered by its side effect profile and therefore, there is an inclination to change to a less toxic agent for maintenance therapy. Dronedarone, the medication being studied in this trial, has a slightly different structure to amiodarone and therefore has a reduced likelihood of accumulating in tissues. It also has been shown to have a favourable safety profile in clinical studies. To analyse any effects of amiodarone’s long half-life, three different ways of starting dronedarone will be studied: immediate start (24 hours after last amiodarone dose), start 2 weeks after last amiodarone dose, start 4 weeks after last amiodarone dose. This study is intended for patients with persistent AF (>72 hours) who have not had any amiodarone treatment in the past 3 months. Sixty patients from 5 UK hospitals will take part and attend up to 10 visits over a 20 week period. The rate of recurrence of AF will be studied in each of group at one and two months after stopping amiodarone.

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  10/H0806/63

• Date of REC Opinion

  26 Aug 2010

• REC opinion

  Further Information Favourable Opinion