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.
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.
Duke Scholars
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Related Subject Headings
- Treatment Outcome
- Tachycardia, Ventricular
- Research Design
- Randomized Controlled Trials as Topic
- Piperazines
- Imidazolidines
- Hydantoins
- Humans
- Drug Administration Schedule
- Double-Blind Method
Citation
Published In
DOI
ISSN
Publication Date
Volume
Issue
Start / End Page
Location
Related Subject Headings
- Treatment Outcome
- Tachycardia, Ventricular
- Research Design
- Randomized Controlled Trials as Topic
- Piperazines
- Imidazolidines
- Hydantoins
- Humans
- Drug Administration Schedule
- Double-Blind Method