Design of the SHock inhibition evaluation with Azimilide (SHIELD) study: A novel method to assess antiarrhythmic drug effect in patients

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, azimil...

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Bibliographic Details
Published in:The American journal of cardiology 2005-01, Vol.95 (2), p.274
Main Authors: Pratt, Craig M, Dorian, Paul, Al-Khalidi, Hussein R, Brum, Jose M
Format: Article
Language:English
Subjects:
Cardiac arrhythmia
Defibrillators
Design
Drug therapy
Statistical analysis
Studies
Online Access:Get full text
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Summary: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 ABSTRACT]
ISSN:0002-9149
1879-1913