Treatment of cardiovascular disease with low dose Rivaroxaban in Advanced Chronic Kidney Disease (TRACK)
Patients with advanced chronic kidney disease (CKD), including end-stage kidney disease (ESKD) patients receiving dialysis, are at increased risk of cardiovascular mortality, thrombotic cardiovascular events, and major bleeding complications. No trial has investigated effectiveness of antithrombotic agents in the prevention of cardiovascular events or death specifically in people with advanced stages of CKD or ESKD.
To determine whether low dose rivaroxaban (2.5 mg twice daily), compared to placebo, significantly reduces the risk of a composite outcome of;
- Cardiovascular death,
- Non-fatal myocardial infarction,
- Stroke, or
- Peripheral arterial disease events,
in patients with CKD stages 4 or 5 or dialysis-dependent ESKD, and an elevated cardiovascular risk (marked by the presence of coronary artery disease or peripheral arterial disease, or non-haemorrhagic non-lacunar stroke OR diabetes mellitus OR age ≥65 years).
The TRACK trial is an investigator-initiated, multicentre, international, prospective, randomised, double blind, 1:1 placebo-controlled, parallel group, event-driven trial.
Participants will be randomised to either:
- Experimental intervention
Rivaroxaban 2.5 mg orally twice daily
- Control intervention
Matched placebo tablet twice daily
Recruitment of participants into TRACK will cease following the randomisation of approximately 2000 participants globally. Participants will be recruited from a number of countries, not limited to, Australia, China, Canada, India, France, Malaysia, Singapore, Philippines, Taiwan. The trial will enrol participants over a period of approximately 3 years. The total trial duration is expected to be approximately 5 years from ‘First Patient In’ (FPI) until the final participant assessment.