Vernakalant hydrochloride for rapid conversion of atrial fibrillation: a phase 3, randomized, placebo-controlled trial.

Journal Article (Clinical Trial, Phase III;Journal Article;Multicenter Study)

BACKGROUND: The present study assessed the efficacy and safety of vernakalant hydrochloride (RSD1235), a novel compound, for the conversion of atrial fibrillation (AF). METHODS AND RESULTS: Patients were randomized in a 2:1 ratio to receive vernakalant or placebo and were stratified by AF duration of 3 hours to 7 days (short duration) and 8 to 45 days (long duration). A first infusion of placebo or vernakalant (3 mg/kg) was given for 10 minutes, followed by a second infusion of placebo or vernakalant (2 mg/kg) 15 minutes later if AF was not terminated. The primary end point was conversion of AF to sinus rhythm for at least 1 minute within 90 minutes of the start of drug infusion in the short-duration AF group. A total of 336 patients were randomized and received treatment (short duration, n=220; long duration, n=116). Of the 145 vernakalant patients, 75 (51.7%) in the short-duration AF group converted to sinus rhythm (median time, 11 minutes) compared with 3 of the 75 placebo patients (4.0%; P<0.001). Overall, in the short- and long-duration AF groups, 83 of the 221 vernakalant patients (37.6%) experienced termination of AF compared with 3 of the 115 placebo patients (2.6%; P<0.001). Transient dysgeusia and sneezing were the most common side effects in vernakalant-treated patients. Four vernakalant-related serious adverse events (hypotension [2 events], complete atrioventricular block, and cardiogenic shock) occurred in 3 patients. CONCLUSIONS: Vernakalant demonstrated rapid conversion of short-duration AF and was well tolerated.

Full Text

Duke Authors

Cited Authors

  • Roy, D; Pratt, CM; Torp-Pedersen, C; Wyse, DG; Toft, E; Juul-Moller, S; Nielsen, T; Rasmussen, SL; Stiell, IG; Coutu, B; Ip, JH; Pritchett, ELC; Camm, AJ; Atrial Arrhythmia Conversion Trial Investigators,

Published Date

  • March 25, 2008

Published In

Volume / Issue

  • 117 / 12

Start / End Page

  • 1518 - 1525

PubMed ID

  • 18332267

Electronic International Standard Serial Number (EISSN)

  • 1524-4539

Digital Object Identifier (DOI)

  • 10.1161/CIRCULATIONAHA.107.723866

Language

  • eng

Conference Location

  • United States