Treatment of Cardiovascular Disease With Low Dose Rivaroxaban in Advanced Chronic Kidney Disease
TRACK
1 other identifier
interventional
1,753
12 countries
88
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2021
Longer than P75 for phase_3
88 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 27, 2019
CompletedFirst Posted
Study publicly available on registry
May 31, 2019
CompletedStudy Start
First participant enrolled
January 18, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2025
CompletedMarch 23, 2026
March 1, 2026
4.8 years
May 27, 2019
March 18, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (9)
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.
5 years or trial closure
Composite outcome of all-cause death, non-fatal myocardial infarction, or stroke.
5 years or trial closure
Incidence of Cardiovascular Death
5 years or trial closure
Incidence of Non-Fatal Myocardial Infarction
5 years or trial closure
- +4 more secondary outcomes
Other Outcomes (2)
Cost Effectiveness of Intervention - Cost of intervention, & Net benefit in time to MACE event in intervention, when compared to placebo.
5 years or trial closure
Incidence of Thrombosis of dialysis vascular access
5 years or trial closure
Study Arms (2)
Rivaroxaban
EXPERIMENTALRivaroxaban 2.5mg, twice daily.
Placebo
PLACEBO COMPARATORMatched placebo, twice daily.
Interventions
Rivaroxaban is an orally administered selective direct factor Xa inhibitor.
Eligibility Criteria
You may qualify if:
- Age ≥18 years,
- 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,
- Elevated cardiovascular risk, defined by at least one of the following:
- History of Coronary Artery Disease (CAD) or PAD or non-haemorrhagic non-lacunar stroke, or
- Diabetes mellitus, or
- Age ≥65 years.
You may not qualify if:
- Mechanical/prosthetic heart valve (does not include bioprosthetic valves that do not require therapeutic anticoagulation),
- Indication for, or contraindication to, anticoagulant therapy,
- High bleeding risk including any coagulopathy,
- Lesion or condition considered to be a significant risk of major bleeding,
- Major bleeding episode in the 30 days prior to study enrolment, or any active and clinically significant bleeding,
- 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,
- Concurrent treatment with strong inhibitors of combined CYP3A4 and P-glycoprotein; or strong inducers of CYP3A4,
- Any stroke within 1 month prior to enrolment,
- Any previous history of a haemorrhagic or lacunar stroke,
- Severe heart failure with known ejection fraction \<30% or New York Heart Association class III or IV symptoms,
- History of hypersensitivity or known contraindication to rivaroxaban,
- Uncontrolled hypertension (systolic BP ≥180 mm Hg or diastolic BP ≥110 mm Hg), at the time of screening
- Haemoglobin \<90 g/L, or platelet count \<100 x 109/L,
- Significant liver disease (defined as Child-Pugh Class B or C) or Alanine Aminotransferase (ALT) \>3 times upper normal limit,
- Kidney transplant recipients with a functioning allograft, or scheduled for living-donor kidney transplant surgery,
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The George Institutelead
- Emerald Clinical Inc.collaborator
- Bayercollaborator
- Central Hospital, Nancy, Francecollaborator
- King Abdullah International Medical Research Centercollaborator
Study Sites (88)
Canberra Hospital
Garran, Australian Capital Territory, 2605, Australia
Concord Repatriation General Hospital
Concord, New South Wales, 2139, Australia
Nepean Hospital
Kingswood, New South Wales, 2747, Australia
St George Hospital
Kogarah, New South Wales, 2217, Australia
Prince of Wales Hospital
Randwick, New South Wales, 2031, Australia
Royal North Shore Hospital
St Leonards, New South Wales, 2065, Australia
Wollongong Hospital
Wollongong, New South Wales, 2500, Australia
Logan Hospital
Meadowbrook, Queensland, 4131, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
Bendigo Health
Bendigo, Victoria, 3552, Australia
Sunshine Hospital
St Albans, Victoria, 3021, Australia
AZ Sint-Jan Brugge
Bruges, Belgium
University of Alberta
Edmonton, Canada
Research St. Joseph's - Hamilton
Hamilton, Canada
Centre Hospitalier Régional Universitaire de Nancy
Nancy, Meurthe-et-Moselle, 54035, France
CH Boulogne-sur-Mer, (CH Boulogne-sur-Mer)
Boulogne-sur-Mer, 62200, France
Hôpital de la Cavale Blanche, (CHU Brest)
Brest, 29200, France
AURAL Colmar, (AURAL Colmar)
Colmar, 68000, France
Hopital Louis Pasteur (CH Colmar)
Colmar, France
AURAL Haguenau, (AURAL Haguenau)
Haguenau, 67500, France
CH Haguenau, (CH Haguenau)
Haguenau, 67500, France
CH Le Puy-en-Velay
Le Puy-en-Velay, France
Hôpital Edouard Herriot, (CHU Lyon)
Lyon, 69003, France
Hôpital de la Conception, (AP-HM)
Marseille, 13005, France
AURAL Mulhouse, (AURAL Mulhouse)
Mulhouse, 68100, France
CH Mulhouse, (CH Mulhouse)
Mulhouse, 68100, France
Hôpital Pasteur, (CHU Nice)
Nice, 06000, France
Hôpital de la Maison Blanche, (CHU Reims)
Reims, 51092, France
AURAL Strasbourg, (AURAL Strasbourg)
Strasbourg, 67000, France
Hôpital Bretonneau, (CHRU Tours)
Tours, 37000, France
Hôpitaux de Brbaois, (ALTIR)
Vandœuvre-lès-Nancy, 54500, France
KRH Klinikum Siloah
Hanover, Germany
All India Institute Of Medical Sciences, Raipur
Raipur, Chhattisgarh, 700020, India
Muljibhai Patel Urological Hospital
Nadiād, Gujarat, 387001, India
Noble Annex Hospital
Hadapsar, Pune Maharashtra, 411013, India
All India Institute of Medical Sciences, Bathinda
Bathinda, Punjab, 151001, India
Aykai Super Speciality Hospital, Ludhiana
Ludhiana, Punjab, 141010, India
Aysha Hospital
Chennai, Tamil Nadu, 600010, India
Apollo Hospital
Chennai, Tamil Nadu, India
Osmania General Hospital
Hyderabad, Telangana, 500012, India
Citizens Hospital
Hyderabad, Telangana, 500019, India
Nizam's Institute of Medical Sciences, Hyderabad
Hyderabad, Telangana, 500082, India
Nutema Hospital
Meerut, Uttar Pradesh, India
AIIMS Bhubaneswar
Bhubaneswar, India
Postgraduate Institute of Medical Education and Research, Chandigarh
Chandigarh, 160012, India
KG Hospital, K.Govindaswamy Naidu Medical Trust
Coimbatore, 641018, India
Asian Institute of Nephrology and Urology
Hyderabad, India
VS Hospital
Kilpauk, 600010, India
Institute of Post-Graduate Medical Education and Research
Kolkata, 700020, India
Nil Ratan Sircar Medical College and Hospital
Kolkata, India
Government Hospital
Nandyāl, 518501, India
Safdarjung Hospital
New Delhi, India
Government Hospital
Proddatūr, 516362, India
Hospital Sultanah Bahiyah
Alor Star, Kedah, 05460, Malaysia
Hospital Raja Perempuan Zainab II
Kota Bharu, Kelantan, 15586, Malaysia
Hospital Canselor Tuanku Muhriz
Kuala Lumpur, Kuala Lumpur, 56000, Malaysia
University of Malaya Medical Centre
Kuala Lumpur, Kuala Lumpur, 59100, Malaysia
Hospital Tuanku Ja'afar, Seremban
Seremban, Negeri Sembilan, 70300, Malaysia
Hospital Raja Permaisuri Bainun, Ipoh
Ipoh, Perak, 30450, Malaysia
Hospital Seberang Jaya
Seberang Jaya, Pulau Pinang, 13700, Malaysia
Hospital Queen Elizabeth, Kota Kinabalu
Kota Kinabalu, Sabah, 88200, Malaysia
Hospital Kajang
Kajang, Selangor, 43000, Malaysia
Hospital Ampang
Ampang, Malaysia
Hospital Pakar Sultanah Fatimah Muar
Muar town, Malaysia
Tribhuvan University College
Kathmandu, Nepal
Hemodialysis Care Project North Centre
Al Yāsamīn, Riyadh Region, 13322, Saudi Arabia
Hemodialysis King Abdullah Centre
Al Yāsamīn, Riyadh Region, 13322, Saudi Arabia
Dialysis Centre - King Abdul Aziz Medical City (KAMC)
Ar Rimāyah, Riyadh Region, 11481, Saudi Arabia
Hemodialysis Care Project South Centre
Riyadh, Riyadh Region, 12799-6176, Saudi Arabia
King Abdulaziz Medical City - Western Region - Jeddah, Ministry of National Guard - Health Affairs
Jeddah, Saudi Arabia
King Saud University Medical City (KSUMC)
Riyadh, Saudi Arabia
Tan Tock Seng Hospital
Singapore, 308433, Singapore
Khoo Teck Puat Hospital
Singapore, 767828, Singapore
Fu-Jen Catholic University Hospital
Taishan, New Taipei City, 243, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807, Taiwan
Kaohsiung Chang-Gung Memorial Hospital
Kaohsiung City, 833, Taiwan
Chung-Shan Medical University Hospital
Taichung, 402, Taiwan
Wan fang Hospital
Taipei, 116, Taiwan
Taipei Tzu Chi Hospital
Taipei, 231, Taiwan
Chang Gung Memorial Hospital, Linkou Medical Center
Taoyuan District, 333, Taiwan
Fattouma Bourguiba Hospital
Monastir, Tunisia
Hedi chaker Hospital
Sfax, Tunisia
Sahloul Hospital
Sousse, Tunisia
Charles Nicolle Hospital
Tunis, Tunisia
La Rabta Hospital
Tunis, Tunisia
Military Hospital
Tunis, Tunisia
Mongi Slim Hospital
Tunis, Tunisia
Taher Sfar Hospital
Tunis, Tunisia
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Sunil Badve
The George Institute
- STUDY CHAIR
Martin Gallagher
The George Institute
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Quadruple-blind, Placebo-controlled
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 27, 2019
First Posted
May 31, 2019
Study Start
January 18, 2021
Primary Completion
October 30, 2025
Study Completion
October 30, 2025
Last Updated
March 23, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- To be confirmed
- 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.
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.