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

NCT ID: NCT03969953

Last Updated: 2025-11-25

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 2000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-14
• Study Completion Date: 2025-12-01

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).

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.

Conditions

Chronic Kidney Diseases; Dialysis-dependent Kidney Failure; Cardiovascular Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Rivaroxaban

Rivaroxaban 2.5mg, twice daily.

Group Type: EXPERIMENTAL

Rivaroxaban 2.5 Mg Oral Tablet

Intervention Type: DRUG

Rivaroxaban is an orally administered selective direct factor Xa inhibitor.

Placebo

Matched placebo, twice daily.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Rivaroxaban matched placebo

Interventions

Rivaroxaban 2.5 Mg Oral Tablet

Rivaroxaban is an orally administered selective direct factor Xa inhibitor.

Intervention Type: DRUG

Placebo

Rivaroxaban matched placebo

Intervention Type: OTHER

Other Intervention Names

Xarelto

Eligibility Criteria

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

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emerald Clinical Inc.

INDUSTRY

Sponsor Role: collaborator

Bayer

INDUSTRY

Sponsor Role: collaborator

Central Hospital, Nancy, France

OTHER

Sponsor Role: collaborator

King Abdullah International Medical Research Center

OTHER

Sponsor Role: collaborator

The George Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sunil Badve

Role: STUDY_CHAIR

The George Institute

Martin Gallagher

Role: STUDY_CHAIR

The George Institute

Locations

Canberra Hospital

Garran, Australian Capital Territory, Australia

Concord Repatriation General Hospital

Concord, New South Wales, Australia

Nepean Hospital

Kingswood, New South Wales, Australia

St George Hospital

Kogarah, New South Wales, Australia

Prince of Wales Hospital

Randwick, New South Wales, Australia

Royal North Shore Hospital

St Leonards, New South Wales, Australia

Wollongong Hospital

Wollongong, New South Wales, Australia

Logan Hospital

Meadowbrook, Queensland, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Bendigo Health

Bendigo, Victoria, Australia

Sunshine Hospital

St Albans, Victoria, 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, France

CH Boulogne-sur-Mer, (CH Boulogne-sur-Mer)

Boulogne-sur-Mer, , France

Hôpital de la Cavale Blanche, (CHU Brest)

Brest, , France

AURAL Colmar, (AURAL Colmar)

Colmar, , France

Hopital Louis Pasteur (CH Colmar)

Colmar, , France

AURAL Haguenau, (AURAL Haguenau)

Haguenau, , France

CH Haguenau, (CH Haguenau)

Haguenau, , France

CH Le Puy-en-Velay

Le Puy-en-Velay, , France

Hôpital Edouard Herriot, (CHU Lyon)

Lyon, , France

Hôpital de la Conception, (AP-HM)

Marseille, , France

AURAL Mulhouse, (AURAL Mulhouse)

Mulhouse, , France

CH Mulhouse, (CH Mulhouse)

Mulhouse, , France

Hôpital Pasteur, (CHU Nice)

Nice, , France

Hôpital de la Maison Blanche, (CHU Reims)

Reims, , France

AURAL Strasbourg, (AURAL Strasbourg)

Strasbourg, , France

Hôpital Bretonneau, (CHRU Tours)

Tours, , France

Hôpitaux de Brbaois, (ALTIR)

Vandœuvre-lès-Nancy, , France

KRH Klinikum Siloah

Hanover, , Germany

All India Institute Of Medical Sciences, Raipur

Raipur, Chhattisgarh, India

Muljibhai Patel Urological Hospital

Nadiād, Gujarat, India

Noble Annex Hospital

Hadapsar, Pune Maharashtra, India

All India Institute of Medical Sciences, Bathinda

Bathinda, Punjab, India

Aykai Super Speciality Hospital, Ludhiana

Ludhiana, Punjab, India

Aysha Hospital

Chennai, Tamil Nadu, India

Apollo Hospital

Chennai, Tamil Nadu, India

Osmania General Hospital

Hyderabad, Telangana, India

Citizens Hospital

Hyderabad, Telangana, India

Nizam's Institute of Medical Sciences, Hyderabad

Hyderabad, Telangana, India

Nutema Hospital

Meerut, Uttar Pradesh, India

AIIMS Bhubaneswar

Bhubaneswar, , India

Postgraduate Institute of Medical Education and Research, Chandigarh

Chandigarh, , India

KG Hospital, K.Govindaswamy Naidu Medical Trust

Coimbatore, , India

Asian Institute of Nephrology and Urology

Hyderabad, , India

VS Hospital

Kilpauk, , India

Institute of Post-Graduate Medical Education and Research

Kolkata, , India

Nil Ratan Sircar Medical College and Hospital

Kolkata, , India

Government Hospital

Nandyāl, , India

Safdarjung Hospital

New Delhi, , India

Government Hospital

Proddatūr, , India

Hospital Sultanah Bahiyah

Alor Star, Kedah, Malaysia

Hospital Raja Perempuan Zainab II

Kota Bharu, Kelantan, Malaysia

Hospital Canselor Tuanku Muhriz

Kuala Lumpur, Kuala Lumpur, Malaysia

University of Malaya Medical Centre

Kuala Lumpur, Kuala Lumpur, Malaysia

Hospital Tuanku Ja'afar, Seremban

Seremban, Negeri Sembilan, Malaysia

Hospital Raja Permaisuri Bainun, Ipoh

Ipoh, Perak, Malaysia

Hospital Seberang Jaya

Seberang Jaya, Pulau Pinang, Malaysia

Hospital Queen Elizabeth, Kota Kinabalu

Kota Kinabalu, Sabah, Malaysia

Hospital Kajang

Kajang, Selangor, 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, Saudi Arabia

Hemodialysis King Abdullah Centre

Al Yāsamīn, Riyadh Region, Saudi Arabia

Dialysis Centre - King Abdul Aziz Medical City (KAMC)

Ar Rimāyah, Riyadh Region, Saudi Arabia

Hemodialysis Care Project South Centre

Riyadh, Riyadh Region, 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, , Singapore

Khoo Teck Puat Hospital

Singapore, , Singapore

Fu-Jen Catholic University Hospital

Taishan, New Taipei City, Taiwan

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, , Taiwan

Kaohsiung Chang-Gung Memorial Hospital

Kaohsiung City, , Taiwan

Chung-Shan Medical University Hospital

Taichung, , Taiwan

Wan fang Hospital

Taipei, , Taiwan

Taipei Tzu Chi Hospital

Taipei, , Taiwan

Chang Gung Memorial Hospital, Linkou Medical Center

Taoyuan District, , 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

Countries

Australia; Belgium; Canada; France; Germany; India; Malaysia; Nepal; Saudi Arabia; Singapore; Taiwan; Tunisia

Related Links

https://www.tracktrial.org/

Trial Website

Other Identifiers

0040139

Identifier Type: -

Identifier Source: org_study_id