Statistical Analysis Plan for the Treatment of Cardiovascular disease with low dose Rivaroxaban in Advanced CKD (TRACK) trial

1 Abstract The Treatment of cardiovascular disease with low dose Rivaroxaban in Advanced Chronic Kidney Disease (TRACK) trial is a randomised quadruple-blind phase IV clinical trial to determine whether low-dose rivaroxaban (2.5 mg daily) reduces the risk of major adverse cardiovascular events compared to placebo. It aims to recruit approximately 2,000 patients with advanced chronic kidney disease (stages 4, 5 or dialysis-dependent) and an elevated cardiovascular risk. This statistical analysis plan pre-specifies the method of analysis for every outcome and key variable collected in the trial. The primary outcome is the time from randomisation to first occurrence of major cardiovascular event including death from cardiovascular cause, myocardial infarction, stroke or peripheral artery disease event. 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.