The George Institute For Global Health
Global
United Kingdom
India
China
Australia

Treatment of cardiovascular disease with low dose Rivaroxaban in Advanced Chronic Kidney Disease

Project status: 
Active
Start date: 
09/2019

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.

Aim:
To determine whether low dose rivaroxaban (2.5 mg twice daily), compared to placebo, significantly reduces the risk of a composite outcome of;

  • CV 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 stable coronary artery disease or peripheral arterial disease, or non-hemorrhagic non-lacunar stroke OR diabetes mellitus OR age ≥65 years).

Methodology:
The TRACK trial is an investigator-initiated, international, prospective, randomised, double-blind, placebo-controlled trial.