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