title: 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.
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.
authors.affiliation: 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
authors.forename: Craig M
authors.initials: CM
authors.lastname: Pratt
authors.forename: Paul
authors.initials: P
authors.lastname: Dorian
authors.forename: Hussein R
authors.initials: HR
authors.lastname: Al-Khalidi
authors.forename: Jose M
authors.initials: JM
authors.lastname: Brum
authors.forename: Martin
authors.initials: M
authors.lastname: Borggrefe
authors.forename: Daljit S
authors.initials: DS
authors.lastname: Tatla
authors.forename: Johannes
authors.initials: J
authors.lastname: Brachmann
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Myerburg
authors.forename: David S
authors.initials: DS
authors.lastname: Cannom
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Holroyde
authors.forename: Michael
authors.initials: M
authors.lastname: van der Laan
authors.forename: Stefan H
authors.initials: SH
authors.lastname: Hohnloser
mesh_terms: 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
chemical_list: D000889:Anti-Arrhythmia Agents; D006827:Hydantoins; D048289:Imidazolidines; D010879:Piperazines; C086123:azimilide