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.

Journal Article

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.

Full Text

Duke Authors

Cited Authors

  • Pratt, CM; Dorian, P; Al-Khalidi, HR; Brum, JM; Borggrefe, M; Tatla, DS; Brachmann, J; Myerburg, RJ; Cannom, DS; Holroyde, MJ; van der Laan, M; Hohnloser, SH; SHIELD Investigators,

Published Date

  • January 15, 2005

Published In

Volume / Issue

  • 95 / 2

Start / End Page

  • 274 - 276

PubMed ID

  • 15642569

International Standard Serial Number (ISSN)

  • 0002-9149

Digital Object Identifier (DOI)

  • 10.1016/j.amjcard.2004.08.096

Language

  • eng

Conference Location

  • United States