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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Canberra Hospital
  Garran, Australian Capital Territory, Australia Recruiting
• Concord Repatriation General Hospital
  Concord, New South Wales, Australia Recruiting
• Nepean Hospital
  Kingswood, New South Wales, Australia Recruiting
• St George Hospital
  Kogarah, New South Wales, Australia Recruiting
• Prince of Wales Hospital
  Randwick, New South Wales, Australia Recruiting
• Royal North Shore Hospital
  St Leonards, New South Wales, Australia Recruiting

+33 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Sunil Badve
• Email: sbadve@georgeinstitute.org.au
• Phone: +61 2 8052 4636

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.