Statistical Analysis Plan for the Aspiring to Reduce Events in Dialysis Trial (ASPIRED)

Abstract The ASPIRED trial aims to determine whether a daily low-dose of aspirin is effective in preventing major cardiovascular events when compared to placebo in patients receiving dialysis. It is designed as a pragmatic trial two-arm double-blind randomised trial conducted within an established Dialysis Registry consisting of at least 80 centres and 30,000 participants. This statistical analysis plan pre-specifies the method of analysis for every outcome and key variables collected in the trial. The primary outcome is time from randomisation to first occurrence of major cardiovascular event including myocardial infarction, ischemic stroke or death from cardiovascular cause. The primary analysis will consist in a Cox proportional hazard model adjusted for stratification variables. The analysis plan also includes planned sensitivity analyses including covariate adjustments and subgroup analyses.