TY - JOUR
T1 - Design of the SHock Inhibition Evaluation with Azimilide (SHIELD) study
T2 - A novel method to assess antiarrhythmic drug effect in patients with an implantable cardioverter-defibrillator
AU - Pratt, Craig M.
AU - Dorian, Paul
AU - Al-Khalidi, Hussein R.
AU - Brum, Jose M.
AU - Borggrefe, Martin
AU - Tatla, Daljit S.
AU - Brachmann, Johannes
AU - Myerburg, Robert J.
AU - Cannom, David S.
AU - Holroyde, Michael J.
AU - Van Der Laan, Michael
AU - Hohnloser, Stefan H.
N1 - Funding Information:
This study was sponsored by Procter & Gamble Pharmaceuticals, Cincinnati, Ohio.
PY - 2005/1/15
Y1 - 2005/1/15
N2 - 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.
AB - 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.
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UR - http://www.scopus.com/inward/citedby.url?scp=19944427142&partnerID=8YFLogxK
U2 - 10.1016/j.amjcard.2004.08.096
DO - 10.1016/j.amjcard.2004.08.096
M3 - Article
C2 - 15642569
AN - SCOPUS:19944427142
SN - 0002-9149
VL - 95
SP - 274
EP - 276
JO - American Journal of Cardiology
JF - American Journal of Cardiology
IS - 2
ER -