2000 Participants Needed

Low Dose Rivaroxaban for Cardiovascular Disease

(TRACK Trial)

Recruiting at 82 trial locations
SB
EL
Overseen ByEnmoore Lin
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

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).

Will I have to stop taking my current medications?

The trial does not specify if you must stop all current medications, but you cannot participate if you are taking certain medications like P2Y12 inhibitors or phosphodiesterase inhibitors and do not wish to stop them. It's best to discuss your current medications with the trial team.

Is low dose Rivaroxaban generally safe for humans?

Rivaroxaban (also known as Xarelto) has been shown to be generally safe in various studies for conditions like preventing blood clots after surgery and treating deep vein thrombosis. However, in high-risk patients with antiphospholipid syndrome, it was associated with more adverse events compared to warfarin, indicating that safety can vary depending on the specific condition and patient group.12345

How does the drug Rivaroxaban differ from other treatments for cardiovascular disease?

Rivaroxaban is unique because it is a direct inhibitor of factor Xa, which helps prevent blood clots, and it is taken orally with high bioavailability, meaning the body can use it effectively. Unlike some other anticoagulants, it does not require routine blood monitoring and has a low risk of interacting with other drugs.36789

What data supports the effectiveness of the drug Rivaroxaban for cardiovascular disease?

Research shows that Rivaroxaban, when combined with aspirin, leads to better outcomes in preventing recurrent cardiovascular disease compared to aspirin alone. Additionally, Rivaroxaban has been effective in reducing thrombotic cardiovascular events and mortality in patients with a recent acute coronary syndrome.2391011

Who Is on the Research Team?

SB

Sunil Badve

Principal Investigator

The George Institute

MG

Martin Gallagher

Principal Investigator

The George Institute

Are You a Good Fit for This Trial?

This trial is for people aged 65 or older with advanced chronic kidney disease (stages 4 or 5) or on dialysis, and who also have a high risk of heart problems due to conditions like diabetes, previous strokes, or being over the age of 65. Participants must not have uncontrolled high blood pressure, recent major bleeding, certain heart valve issues, severe liver disease, very low blood counts, be pregnant/breastfeeding in some regions, among other exclusions.

Inclusion Criteria

People able to provide informed consent who meet all of the following inclusion criteria:
I am 65 years old or older.
I am at high risk for heart problems.
See 3 more

Exclusion Criteria

You have a mechanical or prosthetic heart valve that requires medication to prevent blood clots.
I need or cannot take blood thinners.
I have received a kidney transplant and it is working, or I am scheduled for one.
See 14 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive low dose rivaroxaban or placebo to assess the reduction in risk of major adverse cardiac events

5 years or until trial closure

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Rivaroxaban
Trial Overview The TRACK trial is testing whether a low dose of Rivaroxaban can lower the chance of serious heart events in patients with late-stage chronic kidney disease at elevated cardiovascular risk. It's a large global study comparing Rivaroxaban against a placebo pill without any active medicine in it.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: RivaroxabanExperimental Treatment1 Intervention
Rivaroxaban 2.5mg, twice daily.
Group II: PlaceboPlacebo Group1 Intervention
Matched placebo, twice daily.

Rivaroxaban is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Xarelto for:
  • Deep vein thrombosis (DVT)
  • Venous thromboembolism (VTE)
  • Stroke prevention in non-valvular atrial fibrillation
  • Prevention of VTE in patients undergoing knee or hip replacement surgery
🇪🇺
Approved in European Union as Xarelto for:
  • Deep vein thrombosis (DVT)
  • Venous thromboembolism (VTE)
  • Stroke prevention in non-valvular atrial fibrillation
  • Prevention of VTE in patients undergoing knee or hip replacement surgery
  • Prevention of atherothrombotic events in patients with acute coronary syndrome

Find a Clinic Near You

Who Is Running the Clinical Trial?

The George Institute

Lead Sponsor

Trials
84
Recruited
275,000+

Central Hospital, Nancy, France

Collaborator

Trials
782
Recruited
2,447,000+

George Clinical Pty Ltd

Industry Sponsor

Trials
15
Recruited
21,300+

Bayer

Industry Sponsor

Trials
2,291
Recruited
25,560,000+
Founded
1863
Headquarters
Leverkusen, Germany
Known For
Pharmaceutical Innovations
Top Products
Aspirin, Aleve, Yaz, Nexavar

Bill Anderson

Bayer

Chief Executive Officer since 2023

BSc in Chemical Engineering from the University of Texas, MSc in Chemical Engineering and Management from MIT

Michael Devoy profile image

Michael Devoy

Bayer

Chief Medical Officer since 2014

MD, PhD

Centre Hospitalier Régional Universitaire de Nancy

Collaborator

Trials
3
Recruited
8,800+

King Abdullah International Medical Research Center

Collaborator

Trials
49
Recruited
121,000+

Published Research Related to This Trial

Rivaroxaban combined with aspirin is more effective in preventing recurrent cardiovascular events than aspirin alone, with an incremental cost-effectiveness ratio (ICER) of €16,522 per quality-adjusted life-year (QALY) gained, based on a lifetime analysis of patients with coronary artery disease (CAD) or peripheral artery disease (PAD).
The cost-effectiveness of the combination therapy was consistent across subgroups, showing ICERs of €8003 for PAD and €18,599 for CAD, indicating that this treatment strategy is economically viable for improving cardiovascular outcomes in these patient populations.
Cost-Effectiveness Analysis of Rivaroxaban Plus Aspirin Compared with Aspirin Alone in Patients with Coronary and Peripheral Artery Diseases in Italy.Ferrara, P., Cortesi, PA., Di Laura, D., et al.[2022]
Rivaroxaban is a direct factor Xa inhibitor that is effective in preventing venous thromboembolism in patients undergoing elective knee or hip replacement surgery, with a recommended dose of 10 mg per day.
In patients with non-valvular atrial fibrillation, rivaroxaban (20 mg per day) is approved for stroke prevention, and its low dose (2.5 mg twice daily) has shown promise in reducing cardiovascular events in those with recent acute coronary syndrome.
[Rivaroxaban in the prevention and treatment of thromboembolic disorders].Helbing, T., Bode, C., Moser, M.[2015]
Rivaroxaban (Xarelto) is a direct and selective factor Xa inhibitor with high bioavailability (80-100%) and can be taken orally without the need for regular monitoring or dose adjustments, making it convenient for patients.
In clinical trials involving 4,233 patients, rivaroxaban demonstrated effective dosing regimens for preventing and treating venous thromboembolism (VTE) after major orthopedic surgery, with no significant liver toxicity observed.
[Rivaroxaban: clinical pharmacology].Mismetti, P., Laporte, S.[2018]

Citations

Cost-Effectiveness Analysis of Rivaroxaban Plus Aspirin Compared with Aspirin Alone in Patients with Coronary and Peripheral Artery Diseases in Italy. [2022]
[Rivaroxaban in the prevention and treatment of thromboembolic disorders]. [2015]
[Rivaroxaban: clinical pharmacology]. [2018]
Rivaroxaban. A novel, oral, direct factor Xa inhibitor in clinical development for the prevention and treatment of thromboembolic disorders. [2015]
Oral direct factor Xa inhibitors, with special emphasis on rivaroxaban. [2015]
Rivaroxaban vs warfarin in high-risk patients with antiphospholipid syndrome. [2021]
A cross-country comparison of rivaroxaban spontaneous adverse event reports and concomitant medicine use with the potential to increase the risk of harm. [2022]
Bioequivalence and Food Effect Assessment of 2 Rivaroxaban Formulations in Healthy Chinese Volunteers: An Open, Randomized, Single-Dose, and 4-Period Crossover Study. [2022]
Rivaroxaban: a review of its use in acute coronary syndromes. [2021]
Prescribing of low-dose rivaroxaban in patients with atherosclerotic cardiovascular disease in the United Kingdom and the Netherlands. [2023]
Efficacy and safety of low dose rivaroxaban in patients with coronary heart disease: a systematic review and meta-analysis. [2021]
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