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

The TRACK trial is an investigator-initiated, multicentre, prospective, randomised, quadruple-blind (participant, healthcare provider, data collector, outcomes assessor), placebo-controlled phase 3 study. It is a global trial conducted in renal units providing comprehensive CKD care. The study aims to assess a strategy of administering low-dose rivaroxaban (2.5 mg oral tablet) to reduce the risk of major adverse cardiac events (MACE) in a specific patient population. This population consists of individuals with Chronic Kidney Disease (CKD) stages 4 or 5 or dialysis-dependent kidney failure, who also have elevated cardiovascular risk. Elevated risk is defined by a history of coronary artery disease (CAD) or peripheral artery disease (PAD), or non-haemorrhagic non-lacunar stroke, OR diabetes mellitus, OR age ≥65 years. The trial rationale notes the high burden of cardiovascular disease and associated mortality in advanced CKD and dialysis-dependent populations, alongside sparse trial data for managing CVD in these groups. It also highlights an increased risk of bleeding compared to the general population and that 90% of trials evaluating anticoagulant interventions like rivaroxaban exclude these patient populations. The TRACK trial specifically evaluates the effect of low-dose rivaroxaban in patients with CKD and dialysis-dependent kidney failure. The primary outcome is the risk of Major Adverse Cardiac Event (MACE). The study enrolled 1,753 participants (actual enrollment), which is fewer than the initially stated target of approximately 2,000. The trial start date was January 18, 2021, with a primary completion date of October 30, 2025. The abstract does not report any efficacy results, safety data, statistical significance measures (such as p-values, hazard ratios, or confidence intervals), or specific limitations of the study design.

If you have advanced kidney disease, your risk of a heart attack or stroke is frighteningly high. Yet, you're often left out of the very trials that test the medications designed to prevent these events. Why? Because doctors worry that blood thinners might cause dangerous bleeding in people with kidney problems. This leaves a huge gap in care for a vulnerable population. The TRACK trial aimed to fill that gap. It was a major global study that enrolled over 1,700 people with advanced kidney disease or those on dialysis, all of whom were also at high risk for heart disease. The question was simple but critical: could a very low dose of a common blood thinner called rivaroxaban safely reduce their risk of major heart events? The trial was designed to be extremely careful—it was quadruple-blind, meaning no one involved knew who was getting the real medication or a placebo. The goal was to see if this low-dose strategy could finally provide a protective shield against heart attacks and strokes for people who have been waiting for answers. The results will tell us if this approach works and is safe enough for this specific group of patients.