Methods Article for a Study Protocol: Study Design and Baseline Characteristics of the Treatment of Cardiovascular Disease with Low Dose Rivaroxaban in Advanced Chronic Kidney Disease (TRACK) Trial
Year: 2026
Type: article
Study design: Study Protocol
Abstract: INTRODUCTION: Patients with advanced stages of chronic kidney disease (CKD) and dialysis-dependent kidney failure are at a greater risk of cardiovascular events and mortality than those with early stages of CKD. There are no completed definitive randomized trials on the safety and efficacy of anticoagulant therapy in this patient population. METHODS: Treatment of cardiovascular disease with low-dose Rivaroxaban in Advanced Chronic Kidney disease (TRACK) is a multicenter, randomized, placebo-controlled trial (NCT03969953), designed to enroll 1,886 adult participants with CKD stage 4 or 5 (estimated glomerular filtration rate ≤29 mL/min/1.73 m2) or dialysis-dependent kidney failure and high cardiovascular risk (defined as at least one of the following risk factors; coronary artery disease, nonhemorrhagic non-lacunar stroke, peripheral artery disease [PAD], diabetes mellitus, or age ≥65 years). Participants are randomized to rivaroxaban 2.5 mg twice daily or matching placebo. The primary efficacy outcome is a composite of cardiovascular death, myocardial infarction, stroke, or PAD event. The primary safety outcome is major bleeding, defined as a composite of fatal bleeding, bleeding leading to hospitalization, or symptomatic bleeding in a critical area or organ. From January 2021 to July 2025, 1,458 eligible participants (mean age 63.2 years, 700 [48%] age ≥65 years, 432 [29.6%] women, 715 [49%] dialysis-dependent kidney failure and 743 [51%] CKD stage 4 or 5, 1,125 [77.2%] diabetes mellitus, 674 [46.2%] treated with aspirin at baseline) underwent randomization. CONCLUSION: TRACK will evaluate the effect of low dose rivaroxaban on major adverse cardiovascular events in participants with CKD stages 4 and 5 and dialysis-dependent kidney failure, and elevated cardiovascular risk.
Source: American Journal of Nephrology
DOI: 10.1159/000550796
Authors: Sunil V. Badve, Maha Al Ammari, Craig S. Anderson, Laurent Billot, Severine Bompoint, David Collister, An S. De Vriese, John W. Eikelboom, Adrien Flahault, Amit X. Garg, Jeffrey T. Ha, Hiddo J.L. Heerspink, Meg J. Jardine, Shilpanjali Jesudason, Vivekanand Jha, Min Jun, Jenny Landrigan, Adrian Liew, Enmoore Lin, Jicheng Lv, Patrick B. Mark, Jan Menne, Helen Monaghan, Lily Mushahar, Anushka Patel, Helen Pilmore, Vlado Perkovic, Raja Ramachandran, Patrick Rossignol, Ahmed Shaman, Habib Skhiri, Michael Walsh, David C. Wheeler, Muh Geot Wong, Li Zuo, Martin Gallagher, for the TRACK Trial Investigators
Institutions: UNSW Sydney, The George Institute for Global Health, St George Hospital, King Abdulaziz Medical City, Fudan University, University of Alberta, Population Health Research Institute, Canadian VIGOUR Centre, Hamilton Health Sciences, McMaster University, Ghent University, AZ Sint-Jan, Centre Hospitalier Régional et Universitaire de Nancy, Université de Lorraine, Western University, London Health Sciences Centre, London Health Sciences Centre Research Institute, University of Groningen, The University of Sydney, Concord Repatriation General Hospital, Royal Adelaide Hospital, The University of Adelaide, Manipal Academy of Higher Education, Imperial College London, Mount Elizabeth Novena Hospital, Peking University First Hospital, University of Glasgow, Klinikum Region Hannover, Hospital Tuanku Ja’afar, University of Auckland, Auckland City Hospital, Post Graduate Institute of Medical Education and Research, Inserm, Princess Grace Hospital Centre, King Saud University, University of Monastir, University College London, Peking University People's Hospital
Language: English
Subfield: Cardiology and Cardiovascular Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W7128439649