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

Craig M. Pratt, Paul Dorian, Hussein R. Al-Khalidi, Jose M. Brum, Martin Borggrefe, Daljit S. Tatla, Johannes Brachmann, Robert J. Myerburg, David S. Cannom, Michael J. Holroyde, Michael Van Der Laan, Stefan H. Hohnloser

Research output: Contribution to journalArticlepeer-review

2 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)274-276
Number of pages3
JournalAmerican Journal of Cardiology
Volume95
Issue number2
DOIs
StatePublished - Jan 15 2005

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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