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.
Pratt
Craig M
CM
The Methodist DeBakey Heart Center and the Section of Cardiology, Department of Medicine, Baylor College of Medicine, 6565 Fannin Street, Houston, TX 77030, USA. cpratt@bcm.tmc.edu
Dorian
Paul
P
Al-Khalidi
Hussein R
HR
Brum
Jose M
JM
Borggrefe
Martin
M
Tatla
Daljit S
DS
Brachmann
Johannes
J
Myerburg
Robert J
RJ
Cannom
David S
DS
Holroyde
Michael J
MJ
van der Laan
Michael
M
Hohnloser
Stefan H
SH
D000889:Anti-Arrhythmia Agents / Q000008:administration & dosage*; D017147:Defibrillators, Implantable; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D006801:Humans; D006827:Hydantoins; D048289:Imidazolidines / Q000008:administration & dosage*; D010879:Piperazines / Q000008:administration & dosage*; D016032:Randomized Controlled Trials as Topic; D012107:Research Design; D017180:Tachycardia, Ventricular / Q000188:drug therapy / Q000628:therapy*; D016896:Treatment Outcome
D000889:Anti-Arrhythmia Agents; D006827:Hydantoins; D048289:Imidazolidines; D010879:Piperazines; C086123:azimilide