Low-Dose Rivaroxaban Does Not Prevent Cardiovascular Events in Advanced CKD: Study

A new study published in the Journal of American Medical Association show that when compared to a placebo, low-dose rivaroxaban (2.5 mg twice daily) did not lessen significant adverse cardiovascular events in patients with chronic kidney disorder (CKD).

Every year, between 10% and 15% of patients with advanced chronic kidney disease (CKD) have a cardiovascular event that is either fatal or nonfatal. It is unknown how antithrombotic medications affect cardiovascular events in patients with advanced chronic kidney disease.

Therefore, this study was set to ascertain whether low-dose rivaroxaban, when compared to a placebo, lowers the rates of adverse cardiovascular events in patients with advanced chronic kidney disease. 90 sites across 12 countries participated in study.

Patients with dialysis-dependent kidney failure and adults with CKD stages 4 or 5 were eligible to participate. Participants had a history of peripheral artery disease, diabetes, coronary artery disease, nonhemorrhagic, nonlacunar stroke, or were 65 years of age or older.

Enrollment took place from January 2021 to July 2025. Due to ineffectiveness, the trial was terminated early on August 7, 2025. The last follow-up took place on October 30, 2025. Patients were randomized 1:1 to receive either a placebo or 2.5 mg of rivaroxaban twice daily.

A composite of cardiovascular death, nonfatal myocardial infarction, stroke, or a peripheral artery disease event was the main outcome. Major bleeding was the main safety outcome.

1. 1360 (93.3%) of the 1458 randomized patients (mean [SD] age, 63.2 [11.6] years, 432 [29.6%] female) finished the follow-up.

2. 164 patients (22.6%) in the low-dose rivaroxaban group and 151 patients (20.7%) in the placebo group experienced the primary outcome over a median follow-up of 1.7 years (13.0 vs. 11.8 events per 100 person-years; hazard ratio, 1.09 [95% CI, 0.87-1.36]; P =.46).

3. 64 patients (8.8%) on low-dose rivaroxaban and 44 patients (6.0%) on placebo experienced major bleeding (5.1 vs. 3.4 events per 100 person-years; hazard ratio, 1.51 [95% CI, 1.02-2.22]; P =.04).

Overall, Iow-dose rivaroxaban did not lower the risk of a composite cardiovascular outcome in patients with advanced chronic kidney disease (CKD) at high cardiovascular risk.

Source:

Badve, S. V., Perkovic, V., Jha, V., Ramachandran, R., Mushahar, L., Menne, J., De Vriese, A. S., Rossignol, P., Flahault, A., Al Ammari, M., Skhiri, H., Walsh, M., Collister, D., Liew, A., Billot, L., Bompoint, S., Devaux, A., Jun, M., Lin, E., … TRACK Trial Investigators. (2026). Low-dose rivaroxaban and cardiovascular events in advanced kidney disease: The TRACK randomized clinical trial: The TRACK randomized clinical trial. The Journal of the American Medical Association, 336(4), 296–305. https://doi.org/10.1001/jama.2026.9379