drugset / Trial / NCT01447862

Vernakalant Versus Ibutilide In Recent-Onset Atrial Fibrillation

NCT01447862

Phase 4 Completed 101 enrolled Medical University of Vienna
RandomizedParallel-groupOpen-labelTreatment

Summary

Atrial fibrillation is the most common cardiac arrhythmia and is expected to affect about 30 million North Americans and Europeans by 2050. Atrial fibrillation is associated with increased cardiovascular morbidity and mortality, with stroke being an especially important and potentially devastating complication. Many studies have investigated the efficacy of different drugs in converting atrial fibrillation to sinus rhythm. There are numerous randomized controlled trials that have tested the efficacy of agents against placebo and some trials that directly compared the efficacy of two or more different drugs. The class III antiarrhythmic drug Ibutilde is approved for the acute termination of atrial fibrillation and atrial flutter of recent onset and has been shown to be superior to sotalol and equivalent to flecainide in this indication. Recently, the relatively atrial selective antiarrhythmic agent vernakalant has been approved by the European Commission for the rapid conversion of recent onset AF to sinus rhythm in adults. The investigators hypothesize that the period of time needed for cardioversion to sinus rhythm and the efficacy of cardioversion within 90 minutes is different between vernakalant and ibutilide in patients with recent-onset atrial fibrillation.

Timeline

Start
2011-10
Primary completion
2015-05
Completion
2015-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ibutilide Small molecule 1 mg Intravenous
Comparator Vernakalant Other / unclassified 3 mg/kg Intravenous

Indications