Treatment of Cardiovascular Disease With Low Dose Rivaroxaban in Advanced Chronic Kidney Disease (TRACK)

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).

Study Overview

• Status: Completed
• Conditions: Cardiovascular Disease; Chronic Kidney Diseases; Dialysis-dependent Kidney Failure
• Intervention / Treatment: Drug: Rivaroxaban 2.5 Mg Oral Tablet; Other: Placebo

Detailed Description

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. Other trials have demonstrated that rivaroxaban reduces the risk of major cardio-vascular outcomes in high risk patients, and the limited data showed that CKD status did not significantly affect this result.

Hypothesis Compared to placebo, low dose rivaroxaban reduces the risk of major adverse cardiac event (MACE) in people with 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).

Objectives The primary objective is to determine whether low dose rivaroxaban, compared to placebo, significantly reduces the risk of a composite outcome of;

• CV death,
• non-fatal myocardial infarction,
• stroke, or
• peripheral artery disease (PAD) events

in people with CKD stages 4 or 5 or dialysis-dependent kidney failure, and an elevated CV risk (marked by a history of CAD or PAD, or non-haemorrhagic non-lacunar stroke OR diabetes mellitus OR age ≥65 years).

A full list of secondary objectives are detailed in the protocol, and include identifying risk reduction in the treatment group, and whether this treatment is cost effective.

Methodology The TRACK trial is an investigator-initiated, multicentre, prospective, randomised, quadruple-blind (participant, healthcare provider, data collector, outcomes assessor), placebo-controlled trial. The trial will test for the superiority of the trial intervention using a 1:1 allocation to parallel trial groups, on the basis of a pre-specified number of primary outcomes events.

This is a global trial and will be conducted in renal units that provide comprehensive CKD care. Approximately 2,000 participants will be recruited.

• Study Type: Interventional
• Enrollment (Actual): 1753
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Australian Capital Territory
    • Garran, Australian Capital Territory, Australia, 2605
      • Canberra Hospital
  • New South Wales
    • Concord, New South Wales, Australia, 2139
      • Concord Repatriation General Hospital
    • Kingswood, New South Wales, Australia, 2747
      • Nepean Hospital
    • Kogarah, New South Wales, Australia, 2217
      • St George Hospital
    • Randwick, New South Wales, Australia, 2031
      • Prince of Wales Hospital
    • St Leonards, New South Wales, Australia, 2065
      • Royal North Shore Hospital
    • Wollongong, New South Wales, Australia, 2500
      • Wollongong Hospital
  • Queensland
    • Meadowbrook, Queensland, Australia, 4131
      • Logan Hospital
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Royal Adelaide Hospital
  • Victoria
    • Bendigo, Victoria, Australia, 3552
      • Bendigo Health
    • St Albans, Victoria, Australia, 3021
      • Sunshine Hospital
• Belgium
  • Bruges, Belgium
    • AZ Sint-Jan Brugge
• Canada
  • Edmonton, Canada
    • University of Alberta
  • Hamilton, Canada
    • Research St. Joseph's - Hamilton
• France
  • Boulogne-sur-Mer, France, 62200
    • CH Boulogne-sur-Mer, (CH Boulogne-sur-Mer)
  • Brest, France, 29200
    • Hôpital de la Cavale Blanche, (CHU Brest)
  • Colmar, France, 68000
    • AURAL Colmar, (AURAL Colmar)
  • Colmar, France
    • Hopital Louis Pasteur (CH Colmar)
  • Haguenau, France, 67500
    • AURAL Haguenau, (AURAL Haguenau)
  • Haguenau, France, 67500
    • CH Haguenau, (CH Haguenau)
  • Le Puy-en-Velay, France
    • CH Le Puy-en-Velay
  • Lyon, France, 69003
    • Hôpital Edouard Herriot, (CHU Lyon)
  • Marseille, France, 13005
    • Hôpital de la Conception, (AP-HM)
  • Mulhouse, France, 68100
    • AURAL Mulhouse, (AURAL Mulhouse)
  • Mulhouse, France, 68100
    • CH Mulhouse, (CH Mulhouse)
  • Nice, France, 06000
    • Hôpital Pasteur, (CHU Nice)
  • Reims, France, 51092
    • Hôpital de la Maison Blanche, (CHU Reims)
  • Strasbourg, France, 67000
    • AURAL Strasbourg, (AURAL Strasbourg)
  • Tours, France, 37000
    • Hôpital Bretonneau, (CHRU Tours)
  • Vandœuvre-lès-Nancy, France, 54500
    • Hôpitaux de Brbaois, (ALTIR)
  • Meurthe-et-Moselle
    • Nancy, Meurthe-et-Moselle, France, 54035
      • Centre Hospitalier Régional Universitaire de Nancy
• Germany
  • Hanover, Germany
    • KRH Klinikum Siloah
• India
  • Bhubaneswar, India
    • AIIMS Bhubaneswar
  • Chandigarh, India, 160012
    • Postgraduate Institute of Medical Education and Research, Chandigarh
  • Coimbatore, India, 641018
    • KG Hospital, K.Govindaswamy Naidu Medical Trust
  • Hyderabad, India
    • Asian Institute of Nephrology and Urology
  • Kilpauk, India, 600010
    • VS Hospital
  • Kolkata, India
    • Nil Ratan Sircar Medical College and Hospital
  • Kolkata, India, 700020
    • Institute of Post-Graduate Medical Education and Research
  • Nandyāl, India, 518501
    • Government Hospital
  • New Delhi, India
    • Safdarjung Hospital
  • Proddatūr, India, 516362
    • Government Hospital
  • Chhattisgarh
    • Raipur, Chhattisgarh, India, 700020
      • All India Institute of Medical Sciences, Raipur
  • Gujarat
    • Nadiād, Gujarat, India, 387001
      • Muljibhai Patel Urological Hospital
  • Pune Maharashtra
    • Hadapsar, Pune Maharashtra, India, 411013
      • Noble Annex Hospital
  • Punjab
    • Bathinda, Punjab, India, 151001
      • All India Institute of Medical Sciences, Bathinda
    • Ludhiana, Punjab, India, 141010
      • Aykai Super Speciality Hospital, Ludhiana
  • Tamil Nadu
    • Chennai, Tamil Nadu, India
      • Apollo Hospital
    • Chennai, Tamil Nadu, India, 600010
      • Aysha Hospital
  • Telangana
    • Hyderabad, Telangana, India, 500012
      • Osmania General Hospital
    • Hyderabad, Telangana, India, 500019
      • Citizens Hospital
    • Hyderabad, Telangana, India, 500082
      • Nizam's Institute of Medical Sciences, Hyderabad
  • Uttar Pradesh
    • Meerut, Uttar Pradesh, India
      • Nutema Hospital
• Malaysia
  • Ampang, Malaysia
    • Hospital Ampang
  • Muar town, Malaysia
    • Hospital Pakar Sultanah Fatimah Muar
  • Kedah
    • Alor Star, Kedah, Malaysia, 05460
      • Hospital Sultanah Bahiyah
  • Kelantan
    • Kota Bharu, Kelantan, Malaysia, 15586
      • Hospital Raja Perempuan Zainab Ii
  • Kuala Lumpur
    • Kuala Lumpur, Kuala Lumpur, Malaysia, 56000
      • Hospital Canselor Tuanku Muhriz
    • Kuala Lumpur, Kuala Lumpur, Malaysia, 59100
      • University of Malaya Medical Centre
  • Negeri Sembilan
    • Seremban, Negeri Sembilan, Malaysia, 70300
      • Hospital Tuanku Ja'afar, Seremban
  • Perak
    • Ipoh, Perak, Malaysia, 30450
      • Hospital Raja Permaisuri Bainun, Ipoh
  • Pulau Pinang
    • Seberang Jaya, Pulau Pinang, Malaysia, 13700
      • Hospital Seberang Jaya
  • Sabah
    • Kota Kinabalu, Sabah, Malaysia, 88200
      • Hospital Queen Elizabeth, Kota Kinabalu
  • Selangor
    • Kajang, Selangor, Malaysia, 43000
      • Hospital Kajang
• Nepal
  • Kathmandu, Nepal
    • Tribhuvan University College
• Saudi Arabia
  • Jeddah, Saudi Arabia
    • King Abdulaziz Medical City - Western Region - Jeddah, Ministry of National Guard - Health Affairs
  • Riyadh, Saudi Arabia
    • King Saud University Medical City (KSUMC)
  • Riyadh Region
    • Al Yāsamīn, Riyadh Region, Saudi Arabia, 13322
      • Hemodialysis Care Project North Centre
    • Al Yāsamīn, Riyadh Region, Saudi Arabia, 13322
      • Hemodialysis King Abdullah Centre
    • Ar Rimāyah, Riyadh Region, Saudi Arabia, 11481
      • Dialysis Centre - King Abdul Aziz Medical City (KAMC)
    • Riyadh, Riyadh Region, Saudi Arabia, 12799-6176
      • Hemodialysis Care Project South Centre
• Singapore
  • Singapore, Singapore, 308433
    • Tan Tock Seng Hospital
  • Singapore, Singapore, 767828
    • Khoo Teck Puat Hospital
• Taiwan
  • Kaohsiung City, Taiwan, 807
    • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • Kaohsiung City, Taiwan, 833
    • Kaohsiung Chang-Gung Memorial Hospital
  • Taichung, Taiwan, 402
    • Chung-Shan Medical University Hospital
  • Taipei, Taiwan, 116
    • Wan Fang Hospital
  • Taipei, Taiwan, 231
    • Taipei Tzu Chi Hospital
  • Taoyuan District, Taiwan, 333
    • Chang Gung Memorial Hospital, Linkou Medical Center
  • New Taipei City
    • Taishan, New Taipei City, Taiwan, 243
      • Fu-Jen Catholic University Hospital
• Tunisia
  • Monastir, Tunisia
    • Fattouma Bourguiba Hospital
  • Sfax, Tunisia
    • Hédi Chaker Hospital
  • Sousse, Tunisia
    • Sahloul Hospital
  • Tunis, Tunisia
    • La Rabta Hospital
  • Tunis, Tunisia
    • Charles Nicolle Hospital
  • Tunis, Tunisia
    • Military Hospital
  • Tunis, Tunisia
    • Mongi Slim Hospital
  • Tunis, Tunisia
    • Taher Sfar Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• People able to provide informed consent who meet all of the following inclusion criteria:

  1. Age ≥18 years,
  2. Kidney Failure on haemodialysis or peritoneal dialysis, or CKD stage 4 or 5 (eGFR ≤29 mL/min/1.73 m2) not receiving renal replacement therapy,

  3. Elevated cardiovascular risk, defined by at least one of the following:

     1. History of Coronary Artery Disease (CAD) or PAD or non-haemorrhagic non-lacunar stroke, or
     2. Diabetes mellitus, or
     3. Age ≥65 years.

Exclusion Criteria:

• Potential participants must have none of the following exclusion criteria at the time of study enrolment:

  1. Mechanical/prosthetic heart valve (does not include bioprosthetic valves that do not require therapeutic anticoagulation),
  2. Indication for, or contraindication to, anticoagulant therapy,
  3. High bleeding risk including any coagulopathy,
  4. Lesion or condition considered to be a significant risk of major bleeding,
  5. Major bleeding episode in the 30 days prior to study enrolment, or any active and clinically significant bleeding,
  6. Current treatment with P2Y12 inhibitors/adenosine diphosphate (ADP) receptor inhibitors (clopidogrel, prasugrel, ticagrelor, cangrelor) or phosphodiesterase inhibitors (dipyridamole), where the treating physician or patient does not wish to stop these medications,
  7. Concurrent treatment with strong inhibitors of combined CYP3A4 and P-glycoprotein; or strong inducers of CYP3A4,
  8. Any stroke within 1 month prior to enrolment,
  9. Any previous history of a haemorrhagic or lacunar stroke,
  10. Severe heart failure with known ejection fraction <30% or New York Heart Association class III or IV symptoms,
  11. History of hypersensitivity or known contraindication to rivaroxaban,
  12. Uncontrolled hypertension (systolic BP ≥180 mm Hg or diastolic BP ≥110 mm Hg), at the time of screening
  13. Haemoglobin <90 g/L, or platelet count <100 x 109/L,
  14. Significant liver disease (defined as Child-Pugh Class B or C) or Alanine Aminotransferase (ALT) >3 times upper normal limit,
  15. Kidney transplant recipients with a functioning allograft, or scheduled for living-donor kidney transplant surgery,
  16. All countries except Europe: Pregnancy or intention to become pregnant or breast-feeding; Europe only: Women who are not in a postmenopausal state, where postmenopausal is defined as no menses for 12 months without alternative medical causes,
  17. Inability to understand or comply with the requirements of the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rivaroxaban; Rivaroxaban 2.5mg, twice daily.	Drug: Rivaroxaban 2.5 Mg Oral Tablet; Rivaroxaban is an orally administered selective direct factor Xa inhibitor.; Other Names: Xarelto
Placebo Comparator: Placebo; Matched placebo, twice daily.	Other: Placebo; Rivaroxaban matched placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Risk of Major Adverse Cardiac Event (MACE)	To determine whether the intervention, compared to placebo, changes the risk of a composite outcome of; CV death,; non-fatal myocardial infarction,; stroke, or; peripheral artery disease (PAD) events	5 years or trial closure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite outcome of cardiovascular death, non-fatal myocardial infarction, or stroke.	To determine whether the intervention, compared to placebo, changes the risk of a composite outcome of cardiovascular death, non-fatal myocardial infarction, or stroke.	5 years or trial closure
Composite outcome of all-cause death, non-fatal myocardial infarction, stroke, or PAD events.	To determine whether the intervention, compared to placebo, changes the risk of a composite of all-cause death, non-fatal myocardial infarction, stroke, or PAD events.	5 years or trial closure
Composite outcome of all-cause death, non-fatal myocardial infarction, or stroke.	To determine whether the intervention, compared to placebo, changes the risk of a composite of all-cause death, non-fatal myocardial infarction, or stroke.	5 years or trial closure
Incidence of Cardiovascular Death	To determine whether the intervention, compared to placebo, changes the risk of Cardiovascular Death	5 years or trial closure
Incidence of Non-Fatal Myocardial Infarction	To determine whether the intervention, compared to placebo, changes the risk of Non-Fatal Myocardial Infarction	5 years or trial closure
Incidence of Stroke	To determine whether the intervention, compared to placebo, changes the risk of Stroke	5 years or trial closure
Incidence of PAD Events	To determine whether the intervention, compared to placebo, changes the risk of PAD events	5 years or trial closure
Net Clinical Benefit - incidence of MACE & Bleeding	To determine whether the intervention, compared to placebo, changes the risk of a composite outcome of cardiovascular death, non-fatal myocardial infarction, stroke, PAD events, fatal bleeding, or symptomatic bleeding into a critical organ.	5 years or trial closure
Incidence of Venous Thromboembolism	To determine whether the intervention, compared to placebo, changes the risk of Venous Thromboembolism	5 years or trial closure

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cost Effectiveness of Intervention - Cost of intervention, & Net benefit in time to MACE event in intervention, when compared to placebo.	To determine whether the intervention, compared to placebo, is cost effective. Where the primary outcome is positive, the cost of providing the intervention will be assessed against the MACE benefit achieved to determine if the treatment meets regulatory guidelines for cost effectiveness. E.g of the Australian Pharmaceutical Benefits Scheme (PBS).	5 years or trial closure
Incidence of Thrombosis of dialysis vascular access	To determine whether the intervention, compared to placebo, changes the risk of thrombosis of dialysis vascular access among participants with an arteriovenous fistula/graft.	5 years or trial closure

Collaborators and Investigators

• Sponsor: The George Institute
• Collaborators: Bayer; Central Hospital, Nancy, France; King Abdullah International Medical Research Center; Emerald Clinical Inc.
• Investigators: Study Chair: Sunil Badve, The George Institute; Study Chair: Martin Gallagher, The George Institute

Publications and helpful links

Helpful Links

• Trial Website

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2021
• Primary Completion (Actual): October 30, 2025
• Study Completion (Actual): October 30, 2025

Study Registration Dates

• First Submitted: May 27, 2019
• First Submitted That Met QC Criteria: May 29, 2019
• First Posted (Actual): May 31, 2019

Study Record Updates

• Last Update Posted (Actual): March 23, 2026
• Last Update Submitted That Met QC Criteria: March 18, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Rivaroxaban
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Cardiovascular Diseases; Renal Insufficiency, Chronic; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morpholines; Oxazines; Thiophenes; Rivaroxaban
• Other Study ID Numbers: 0040139

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Trial data will be disseminated in the form of a publication to a relevant clinical journal and presentation at appropriate scientific conferences.

Individual participant data that underlie the results reported, after de-identification (text, tables, figures, and appendices), may be shared with Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose.

• IPD Sharing Time Frame: To be confirmed
• IPD Sharing Access Criteria: No data should be released that would compromise the trial, unless specifically for safety reasons.; There must be a strong scientific or other legitimate rationale for the data to be used for the requested purpose.; TRACK Investigators should have a period of exclusivity in which to pursue their aims with the data, before key trial data are made available to other researchers.; Adequate resources must be available in order to comply with the request, and the scientific aims of the study must justify the use of such resources.; Data release complies with the relevant regulations from all relevant countries.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes