TRACK trial to assess low-dose rivaroxaban for MACE in advanced CKD/dialysis patients

Status: COMPLETED | Phase: PHASE3 Condition(s): Chronic Kidney Diseases, Dialysis-dependent Kidney Failure, Cardiovascular Disease Intervention(s): Rivaroxaban 2.5 Mg Oral Tablet (DRUG), Placebo (OTHER) The TRACK trial is an investigator-initiated, multicentre, prospective, randomised, quadruple-blind (participant, healthcare provider, data collector, outcomes assessor), 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 kidney failure, and elevated cardiovascular (CV) risk (marked by a history of CAD or PAD, or non-haemorrhagic non-lacunar stroke OR diabetes mellitus OR age ≥65 years). Detailed: Background and Rationale Chronic Kidney Disease (CKD) is a major international health burden. Despite the unacceptably high burden of cardiovascular disease (CVD) and associated mortality, trial-data on the management of CVD in people with advanced stages of CKD and dialysis-dependent kidney failure are sparse. Risk of bleeding in CKD and dialysis-dependent kidney failure is increased when compared to the general population. Anticoagulant agents, such as rivaroxaban, are a core intervention in the prevention of CVD in the general population. Nevertheless, to mitigate trial risks, 90% of the trials evaluating this form of intervention exclude these patient populations. The TRACK trial will evaluate the effect of low dose rivaroxaban in patients with CKD dialysis-dependent kidney failure. O Primary Outcome(s): Risk of Major Adverse Cardiac Event (MACE) Enrollment: 1753 (ACTUAL) Lead Sponsor: The George Institute Start: 2021-01-18 | Primary Completion: 2025-10-30