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Using low dose rivaroxaban to treat cardiovascular disease in patients with advanced chronic kidney disease

Treatment of Cardiovascular Disease With Low Dose Rivaroxaban in Advanced Chronic Kidney Disease

Phase 3 Interventional The George Institute · NCT03969953

This study is testing if a low dose of rivaroxaban can help reduce serious heart problems in people with advanced chronic kidney disease.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment2000 (estimated)
Ages18 Years and up
SexAll
SponsorThe George Institute Academic / other
Locations83 sites (Garran, Australian Capital Territory and 82 other locations)
Trial IDNCT03969953 on ClinicalTrials.gov

What this trial studies

The TRACK trial is a global, multicentre, randomized, quadruple-blind, placebo-controlled trial aimed at evaluating the effectiveness of low dose rivaroxaban in reducing major adverse cardiac events (MACE) in patients with advanced chronic kidney disease (CKD) stages 4 or 5 or those who are dialysis-dependent. Approximately 2000 participants will be recruited from renal units that provide comprehensive CKD care. The study focuses on individuals with elevated cardiovascular risk, including those with a history of coronary artery disease, diabetes, or those aged 65 and older. The primary objective is to compare the incidence of MACE between the rivaroxaban group and the placebo group.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with CKD stages 4 or 5 or those who are on dialysis, who also have elevated cardiovascular risk.

Not a fit: Patients with mechanical heart valves, contraindications to anticoagulant therapy, or those at high risk of bleeding may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the risk of cardiovascular events in patients with advanced chronic kidney disease.

How similar studies have performed: Other studies have shown that rivaroxaban can reduce cardiovascular risks in high-risk patients, suggesting potential success for this approach in the CKD population.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* People able to provide informed consent who meet all of the following inclusion criteria:

  1. Age ≥18 years,
  2. Kidney Failure on haemodialysis or peritoneal dialysis, or CKD stage 4 or 5 (eGFR ≤29 mL/min/1.73 m2) not receiving renal replacement therapy,
  3. Elevated cardiovascular risk, defined by at least one of the following:

     1. History of Coronary Artery Disease (CAD) or PAD or non-haemorrhagic non-lacunar stroke, or
     2. Diabetes mellitus, or
     3. Age ≥65 years.

Exclusion Criteria:

* Potential participants must have none of the following exclusion criteria at the time of study enrolment:

  1. Mechanical/prosthetic heart valve (does not include bioprosthetic valves that do not require therapeutic anticoagulation),
  2. Indication for, or contraindication to, anticoagulant therapy,
  3. High bleeding risk including any coagulopathy,
  4. Lesion or condition considered to be a significant risk of major bleeding,
  5. Major bleeding episode in the 30 days prior to study enrolment, or any active and clinically significant bleeding,
  6. Current treatment with P2Y12 inhibitors/adenosine diphosphate (ADP) receptor inhibitors (clopidogrel, prasugrel, ticagrelor, cangrelor) or phosphodiesterase inhibitors (dipyridamole), where the treating physician or patient does not wish to stop these medications,
  7. Concurrent treatment with strong inhibitors of combined CYP3A4 and P-glycoprotein; or strong inducers of CYP3A4,
  8. Any stroke within 1 month prior to enrolment,
  9. Any previous history of a haemorrhagic or lacunar stroke,
  10. Severe heart failure with known ejection fraction \<30% or New York Heart Association class III or IV symptoms,
  11. History of hypersensitivity or known contraindication to rivaroxaban,
  12. Uncontrolled hypertension (systolic BP ≥180 mm Hg or diastolic BP ≥110 mm Hg), at the time of screening
  13. Haemoglobin \<90 g/L, or platelet count \<100 x 109/L,
  14. Significant liver disease (defined as Child-Pugh Class B or C) or Alanine Aminotransferase (ALT) \>3 times upper normal limit,
  15. Kidney transplant recipients with a functioning allograft, or scheduled for living-donor kidney transplant surgery,
  16. All countries except Europe: Pregnancy or intention to become pregnant or breast-feeding; Europe only: Women who are not in a postmenopausal state, where postmenopausal is defined as no menses for 12 months without alternative medical causes,
  17. Inability to understand or comply with the requirements of the study.

Where this trial is running

Garran, Australian Capital Territory and 82 other locations

+33 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Chronic Kidney DiseasesDialysis-dependent Kidney FailureCardiovascular DiseaseRivaroxaban
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.