TRACK Trial: Low-Dose Rivaroxaban Fails to Improve Cardiovascular Outcomes in Advanced CKD
Australia: The TRACK trial, the first dedicated placebo-controlled study of anticoagulation for cardiovascular protection in patients with advanced chronic kidney disease (CKD), has found that low-dose rivaroxaban did not reduce major cardiovascular events and was associated with an increased risk of major bleeding.
These findings contrast with the benefits previously observed in broader populations, including those with mild-to-moderate CKD, and suggest that low-dose rivaroxaban should not be used for cardiovascular risk reduction in patients with advanced CKD.
The findings were published in JAMA by Sunil V. Badve from The George Institute for Global Health, University of New South Wales, Sydney, Australia, and colleagues.
Patients with advanced chronic kidney disease face a high cardiovascular risk, with approximately 10% to 15% experiencing a fatal or nonfatal cardiovascular event each year. However, evidence on the benefits and safety of antithrombotic therapy in this population remains limited.
To evaluate the role of low-dose rivaroxaban, researchers conducted the TRACK (Trial of Rivaroxaban in Advanced Chronic Kidney Disease) study, a randomized, double-blind, placebo-controlled trial across 90 centers in 12 countries. The study included adults with stage 4 or 5 CKD, including those on dialysis, who had additional cardiovascular risk factors such as coronary artery disease, peripheral artery disease, prior nonhemorrhagic nonlacunar stroke, diabetes, or age 65 years and older.
Between January 2021 and July 2025, 1,458 participants were randomized to receive rivaroxaban 2.5 mg twice daily or placebo. The trial was stopped early in August 2025 because of a lack of efficacy, with final follow-up completed in October 2025.
The trial revealed the following findings:
- A total of 1,458 patients with advanced CKD were randomized, with a mean age of 63.2 years; 29.6% of participants were women.
- Participants were followed for a median duration of 1.7 years.
- The primary composite cardiovascular outcome occurred in 22.6% of patients receiving low-dose rivaroxaban and 20.7% of those receiving placebo.
- Low-dose rivaroxaban did not significantly reduce the risk of cardiovascular death, nonfatal myocardial infarction, stroke, or peripheral artery disease events compared with placebo (HR 1.09).
- Major bleeding occurred in 8.8% of patients treated with rivaroxaban compared with 6.0% of patients receiving placebo.
- Patients in the rivaroxaban group had a significantly higher risk of major bleeding than those in the placebo group (HR 1.51).
- The trial was stopped early due to lack of efficacy, as rivaroxaban failed to demonstrate cardiovascular benefit while increasing bleeding risk.
The researchers noted several limitations, including a high rate of treatment discontinuation, a lack of data on minor bleeding events, and limited representation of participants from the United States and Black populations, which may affect the generalizability of the findings. In addition, the trial was stopped early, making the treatment effect estimates less certain.
Overall, the TRACK trial found that low-dose rivaroxaban did not reduce cardiovascular events in patients with advanced CKD and was associated with a higher risk of major bleeding, suggesting it should not be used for cardiovascular risk reduction in this population.
Reference:
Badve SV, Perkovic V, Jha V, et al. Low-Dose Rivaroxaban and Cardiovascular Events in Advanced Kidney Disease: The TRACK Randomized Clinical Trial. JAMA. Published online June 04, 2026. doi:10.1001/jama.2026.9379
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