Author/Authors :
Pratt، نويسنده , , Craig M. and Dorian، نويسنده , , Paul and Al-Khalidi، نويسنده , , Hussein R. and Brum، نويسنده , , Jose M. and Borggrefe، نويسنده , , Martin and Tatla، نويسنده , , Daljit S. and Brachmann، نويسنده , , Johannes and Myerburg، نويسنده , , Robert J. and Cannom، نويسنده , , David S. and Holroyde، نويسنده , , Michael J. and van der Laan، نويسنده , , Michael and Hohnloser، نويسنده ,
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.
