Efficacy and Safety of Vernakalant for Cardioversion of Recent-onset Atrial Fibrillation in the Asia-Pacific Region: A Phase 3 Randomized Controlled Trial

J Cardiovasc Pharmacol. 2017 Feb;69(2):86-92. doi: 10.1097/FJC.0000000000000445.

Abstract

Atrial fibrillation (AF) is a common clinically significant cardiac arrhythmia. This phase 3 randomized, double-blind, placebo-controlled trial assessed the efficacy and safety of vernakalant hydrochloride for the pharmacological conversion of AF to sinus rhythm in patients with recent-onset (>3 hours to ≤7 days) symptomatic AF from the Asia-Pacific region. Patients received an infusion of vernakalant (3 mg/kg) or placebo for 10 minutes. If AF had not been terminated 15 minutes later, a second infusion of vernakalant (2 mg/kg) or placebo for 15 minutes was administered. The primary efficacy end point was conversion of AF to sinus rhythm for >1 minute within 90 minutes. The study was terminated early for administrative reasons; 123 patients from Korea, Taiwan, and India were randomized to receive vernakalant (n = 55) or placebo (n = 56). A greater proportion of patients who received vernakalant (52.7%) than placebo (12.5%) met the primary end point (P < 0.001), and cardioversion was faster in the vernakalant group than in the placebo group (P < 0.001). Vernakalant was generally well tolerated; the incidence of treatment-emergent adverse events was similar between the groups. We conclude that vernakalant is efficacious in the rapid cardioversion of recent-onset AF in patients from the Asia-Pacific region.

Publication types

  • Clinical Trial, Phase III
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Aged, 80 and over
  • Anisoles / therapeutic use*
  • Anti-Arrhythmia Agents / therapeutic use*
  • Asia / epidemiology
  • Atrial Fibrillation / drug therapy*
  • Atrial Fibrillation / epidemiology
  • Atrial Fibrillation / physiopathology
  • Double-Blind Method
  • Electric Countershock / methods*
  • Female
  • Humans
  • India / epidemiology
  • Male
  • Middle Aged
  • Pyrrolidines / therapeutic use*
  • Republic of Korea / epidemiology
  • Taiwan / epidemiology
  • Treatment Outcome

Substances

  • Anisoles
  • Anti-Arrhythmia Agents
  • Pyrrolidines
  • vernakalant