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

• Status: Recruiting
• Trial end date: 2026-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The TRACK trial is an investigator-initiated, multicentre, prospective, randomised, double-blind, placebo-controlled trial. TRACK is a global trial and will be conducted in renal units that provide comprehensive CKD care. Approximately 2000 participants will be recruited.

The TRACK trial will assess a strategy of administering low dose rivaroxaban to reduce the risk of major adverse cardiac event (MACE) in people with Chronic Kidney Disease (CKD) stages 4 or 5 or dialysis-dependent End Stage Kidney Disease (ESKD), and elevated cardiovascular (CV) risk, whilst maintaining an acceptable bleeding risk.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The George Institute
• Collaborators: Bayer; George Clinical Pty Ltd
• Treatments: Rivaroxaban

Criteria

Inclusion Criteria:

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

1. Age ≥18 years,

2. ESKD 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,

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),

13. Haemoglobin <90 g/L, or platelet count <100 x 109/L,

14. Significant liver disease 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. Pregnancy or intention to become pregnant or breast-feeding,

17. Inability to understand or comply with the requirements of the study.