Low-dose rivaroxaban (2.5 mg twice daily) is being evaluated against placebo for the reduction of major adverse cardiovascular events in 1458 randomized patients with advanced chronic kidney disease.
RCT (n=1,458)
placebo-controlled
randomized
Yes
Does low-dose rivaroxaban (2.5 mg twice daily) reduce the composite of cardiovascular death, myocardial infarction, stroke, or peripheral artery disease events in patients with advanced chronic kidney disease or dialysis-dependent kidney failure and high cardiovascular risk?
The TRACK trial is an ongoing randomized controlled trial designed to evaluate the efficacy and safety of low-dose rivaroxaban for cardiovascular event prevention in patients with advanced chronic kidney disease and high cardiovascular risk.
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.
Badve et al. (Mon,) conducted a rct in Advanced Chronic Kidney Disease (n=1,458). Rivaroxaban vs. Placebo was evaluated on Composite of cardiovascular death, myocardial infarction, stroke, or PAD event. Low-dose rivaroxaban (2.5 mg twice daily) is being evaluated against placebo for the reduction of major adverse cardiovascular events in 1458 randomized patients with advanced chronic kidney disease.