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.
Can a low-dose blood thinner protect people with advanced kidney disease from heart attacks and strokes?
Plain Language Summary
What this means for you:
A major trial tested a low-dose blood thinner to protect the hearts of people with advanced kidney disease. What this means for you:
A major trial tested a low-dose blood thinner to protect the hearts of people with advanced kidney disease. View Original Abstract ↓
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