Design of the SHock Inhibition Evaluation with Azimilide (SHIELD) study: A novel method to assess antiarrhythmic drug effect in patients with an implantable cardioverter-defibrillator Academic Article uri icon

Overview

MeSH Major

  • Anti-Arrhythmia Agents
  • Defibrillators, Implantable
  • Imidazolidines
  • Piperazines
  • Randomized Controlled Trials as Topic
  • Tachycardia, Ventricular

abstract

  • This report presents the rationale and study design details of the SHock Inhibition Evaluation with Azimilide study, which is recruiting 624 patients with implantable cardioverter-defibrillators (ICDs) who are at risk for life-threatening ventricular arrhythmia, randomized to azimilide 75 mg, azimilide 125 mg, or placebo and followed for 1 year. The objective of this study is to determine the effect of azimilide versus placebo on the symptomatic ventricular arrhythmia burden using a unique statistical analysis based on the unusual temporal distribution of symptomatic ICD therapies. The primary efficacy end points are time to all-cause shocks and time to all-cause shocks plus symptomatic ventricular arrhythmic events triggering antitachycardia pacing measured from randomization.

publication date

  • January 15, 2005

Research

keywords

  • Academic Article

Identity

Language

  • eng

Digital Object Identifier (DOI)

  • 10.1016/j.amjcard.2004.08.096

PubMed ID

  • 15642569

Additional Document Info

start page

  • 274

end page

  • 6

volume

  • 95

number

  • 2