Ranolazine & Dronedarone in Patients with Atrial Fibrillation

• Research type

  Research Study

• Full title

  A phase 2, proof of concept, randomised, placebo-controlled, parallel group study to evaluate the effect of ranolazine and dronedarone when given alone and in combination on atrial fibrillation burden in subjects with paroxysmal atrial fibrillation

• IRAS ID

  85242

• Contact name

  Francis Murgatroyd

• Sponsor organisation

  Gilead Sciences, Inc

• Eudract number

  2011-001134-42

• ISRCTN Number

  No number provided

• Clinicaltrials.gov Identifier

  No number provided

• Research summary

  A Phase 2, Proof of Concept, Randomized, Placebo-Controlled, Parallel Group Study to Evaluate of Ranolazine and Dronedarone When Given Alone and in Combination on Atrial Fibrillation Burden in Subjects with Paroxysmal Atrial Fibrillation.Atrial Fibrillation (AF) is the most common sustained cardiac rhythm disturbance and is associated with a significant morbidity and mortality. Although invasive electrophysiological procedures offer promising therapeutic options for the treatment of AF, medical therapy continues to be the standard treatment for the majority of patients. Current antiarrhythmic drugs used to treat AF have limited clinical efficacy and/or poor safety profile including risk of ventricular proarrhythmia and multi-organ toxicity.Recently published nonclinical data show that ranolazine and dronedarone have synergistic electrophysiological effects on atria, and their combination has the characterisitics of a desired antiarrhytmic drug to treat AF. Clinical data are needed to confirm this hypothesis. The current study was designed as a proof of concept study to evaluate whether treatment with ranolazine 750 mg tablets BID or low dose dronedarone 225 mg capsules BID reduces AFB in subjects with PAF, and whether combination therapy (ranolazine with dronedarone) is superior to individual drug therapy in reducing AFB.Approximately 150 patients will be enrolled to this study in 45 sites in North America and Europe to ensure a minimum of 120 evaluable patients. The participants will be randomised to one of 5 arms in a 1:1:1:1:1 randomisation ratio. The study will consist of 3 phases: pre-treatment (screening and run-in), treatment phase (taking the assigned medication for 12 weeks), and follow-up phase.

• REC name

  London - Brighton & Sussex Research Ethics Committee

• REC reference

  12/LO/0055

• Date of REC Opinion

  17 Apr 2012

• REC opinion

  Further Information Favourable Opinion