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Updated: Jun 5, 2026

Assessment of Vascular Function in Patients With Chronic Kidney Disease
08:50

Assessment of Vascular Function in Patients With Chronic Kidney Disease

Published on: June 16, 2014

Low-Dose Rivaroxaban and Cardiovascular Events in Advanced Kidney Disease: The TRACK Randomized Clinical Trial

Sunil V Badve1,2, Vlado Perkovic3, Vivekanand Jha1,4,5

  • 1The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.

JAMA
|June 4, 2026
PubMed

Insights

Low-dose rivaroxaban did not reduce cardiovascular events in advanced chronic kidney disease (CKD) patients. The drug significantly increased major bleeding risk, highlighting safety concerns for this population.

Area of Science:

  • Cardiology
  • Nephrology
  • Pharmacology

Background:

  • Advanced chronic kidney disease (CKD) affects 10-15% of patients annually with cardiovascular events.
  • Antithrombotic therapies' effects on cardiovascular events in advanced CKD are not well-understood.

Purpose of the Study:

  • To evaluate if low-dose rivaroxaban reduces adverse cardiovascular events compared to placebo in advanced CKD patients.
  • To assess the safety and efficacy of rivaroxaban in this high-risk population.

Main Methods:

  • A randomized, double-blind, placebo-controlled trial involving 1458 patients with CKD stage 4-5 or on dialysis.
  • Patients received either rivaroxaban 2.5 mg twice daily or placebo.
  • The primary outcome was a composite of cardiovascular death, myocardial infarction, stroke, or peripheral artery disease events; major bleeding was the primary safety outcome.

Main Results:

  • Low-dose rivaroxaban did not significantly reduce the composite cardiovascular outcome (HR, 1.09; P=.46).
  • Major bleeding occurred more frequently in the rivaroxaban group (8.8%) compared to placebo (6.0%) (HR, 1.51; P=.04).
  • The trial was stopped early for lack of efficacy.

Conclusions:

  • Low-dose rivaroxaban is not effective in reducing cardiovascular events in patients with advanced CKD.
  • Rivaroxaban use in this population is associated with a significantly higher risk of major bleeding.
  • These findings suggest caution when considering antithrombotic therapy in advanced CKD patients.
Abstract

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