A study of XEN-0103 in patients with Atrial Fibrillation
Research type
Research Study
Full title
A double blind, randomised, placebo-controlled, crossover study assessing the use of XEN-D0103 in patients with paroxysmal atrial fibrillation and implanted pacemakers allowing continuous beat-to-beat monitoring of drug efficacy.
IRAS ID
142292
Contact name
Liz Still
Contact email
Sponsor organisation
Xention Limited
Eudract number
2013-004456-38
ISRCTN Number
xx
Clinicaltrials.gov Identifier
xx
Research summary
Atrial fibrillation (AF) is a very common but elusive arrhythmia, which is difficult to accurately quantify. People with AF often find it difficult to accurately assess whether their AF is improving or worsening. As a result, studies of antiarrhythmic drugs in AF can be unreliable unless people are continuously monitored. We have addressed this by only recruiting patients with AF and existing permanent pacemakers, which is the gold standard for AF detection and quantification.
To accurately assess the effect of XEN-D0103 on AF, it is important that it is not co-administered with other recognised antiarrhythmic drugs (AADs). On that basis, people who take certain AADs may be asked to stop these for the duration of the study. This has the potential to increase the amount of AF people have, and potentially the symptoms associated with AF, but importantly does not pose any danger to their health. We have addressed this issue by explicitly allowing the use of rate-controlling drugs such as betablockers and calcium channel blockers. These can ameliorate the symptoms of AF without masking the potential antiarrhythmic effect of XEN-D0103. Further, such rate-controlling drugs are particularly safe and effective when used in people who already have pacemakers.
The study has been designed as a double-blind randomised controlled study with a placebo comparator rather than an active comparator. This is because although there are a number of available comparator treatments in AF, there is no recognised gold-standard treatment for all patients. It remains the case that the safest recognised treatment for the symptoms of AF is rate-control therapy or no treatment at all. On that basis, our selection of placebo as a comparator is justifiable as it is the most clinically relevant comparator in this population.
REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
14/LO/0069
Date of REC Opinion
11 Apr 2014
REC opinion
Further Information Favourable Opinion