SHIELD-2 Trial

Acronym: Efficacy and Safety Study of Azimilide on the Incidence of CV Hospitalizations/ED Visits or CV Death in Patients with an ICD

Purpose: Assessment of effect of azimilide on cardiovascular death or hospitalization in patients with an implantable cardioverter defibrillator and reduced left ventricular ejection fraction

Format: Prospective, randomized, double-blind, placebo-controlled

Treatment Group: Azimilide 75 mg daily

Control Group: Placebo

Number of Participants: 240

Centers: 138

Primary Outcome(s):

• Adjudicated time to first unplanned cardiovascular hospitalization
• Cardiovascular emergency department visit
• Cardiovascular death

Summary: The study was prematurely discontinued due to withdrawal of sponsorship. The azimilide group had numerical but not statistically significant reductions in the primary outcome of time to first unplanned cardiovascular hospitalization, cardiovascular emergency department visit or cardiovascular death (OR = 0.79; 95% CI, 0.44-1.44), unplanned cardiovascular hospitalization (OR = 0.75; 95% CI, 0.41-1.38), emergency department visits (OR = 0.68; 95% CI, 0.35-1.31) and all-cause shocks (OR = 0.58; 95% CI, 0.32-1.05). There were fewer adverse events in the azimilide group.

Original Publication:

Robinson VM, et al. Am Heart J. 2017;doi:10.1016/j.ahj.2016.10.025.