Methods Article for a Study Protocol: Study Design and Baseline Characteristics of the Treatment of Cardiovascular Disease with Low Dose Rivaroxaban in Advanced Chronic Kidney Disease (TRACK) Trial

INTRODUCTION: Patients with advanced stages of chronic kidney disease (CKD) and dialysis-dependent kidney failure are at a greater risk of cardiovascular events and mortality than those with early stages of CKD. There are no completed definitive randomized trials on the safety and efficacy of anticoagulant therapy in this patient population. METHODS: Treatment of cardiovascular disease with low-dose Rivaroxaban in Advanced Chronic Kidney disease (TRACK) is a multi-center, randomized, placebo-controlled trial (NCT03969953), designed to enrol 1886 adult participants with CKD stage 4 or 5 (estimated glomerular filtration rate 29 mL/min/1.73 m2) or dialysis-dependent kidney failure and high cardiovascular risk (defined as at least one of the following risk factors; coronary artery disease, non-hemorrhagic non-lacunar stroke, peripheral artery disease [PAD], diabetes mellitus, or age 65 years). Participants are randomized to rivaroxaban 2.5 mg twice daily or matching placebo. The primary efficacy outcome is a composite of cardiovascular death, myocardial infarction, stroke, or PAD event. The primary safety outcome is major bleeding, defined as a composite of fatal bleeding, bleeding leading to hospitalization, or symptomatic bleeding in a critical area or organ. From January 2021 through July 2025, 1458 eligible participants (mean age 63.2 years, 700 [48%] age 65 years, 432 [29.6%] women, 715 [49%] dialysis-dependent kidney failure and 743 [51%] CKD stage 4 or 5, 1125 [77.2%] diabetes mellitus, 674 [46.2%] treated with aspirin at baseline) underwent randomization. CONCLUSION: TRACK will evaluate the effect of low dose rivaroxaban on major adverse cardiovascular events in participants with CKD stages 4 and 5 and dialysis-dependent kidney failure, and elevated cardiovascular risk.