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Anticoagulant

Low Dose Rivaroxaban for Cardiovascular Disease (TRACK Trial)

Phase 3
Recruiting
Research Sponsored by The George Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥18 years
Age ≥65 years
Must not have
Kidney transplant recipients with a functioning allograft, or scheduled for living-donor kidney transplant surgery
Major bleeding episode in the 30 days prior to study enrolment, or any active and clinically significant bleeding
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years or trial closure
Awards & highlights
Pivotal Trial

Summary

This trial will help to assess whether low dose rivaroxaban is safe and effective in reducing the risk of MACE in people with CKD.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Rivaroxaban may increase the risk of bleeding including internal bleeding which could be serious. Other side effects might include allergic reactions and possibly liver problems. The exact side effects will be monitored closely during the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I am 65 years old or older.
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I have severe kidney failure or am on dialysis.
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I have diabetes.
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I have a history of heart disease, peripheral artery disease, or a specific type of stroke.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have received a kidney transplant and it is working, or I am scheduled for one.
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I have not had any major bleeding or significant active bleeding recently.
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I am not taking strong drugs that affect liver enzymes or drug transporters.
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I do not have severe liver disease or very high ALT levels.
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I have a high risk of bleeding due to a blood disorder.
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I have had a stroke caused by bleeding or a small vessel blockage.
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I have a condition that could cause serious bleeding.
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My heart is very weak (ejection fraction <30%) or I have severe heart symptoms.
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I understand and can follow the study's requirements.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years or trial closure
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years or trial closure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Risk of Major Adverse Cardiac Event (MACE)
Secondary study objectives
Composite outcome of all-cause death, non-fatal myocardial infarction, or stroke.
Composite outcome of all-cause death, non-fatal myocardial infarction, stroke, or PAD events.
Composite outcome of cardiovascular death, non-fatal myocardial infarction, or stroke.
+6 more
Other study objectives
Cost Effectiveness of Intervention - Cost of intervention, & Net benefit in time to MACE event in intervention, when compared to placebo.
Incidence of Thrombosis of dialysis vascular access

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rivaroxaban 2.5 Mg Oral Tablet
2020
Completed Phase 4
~290

Find a Location

Who is running the clinical trial?

The George InstituteLead Sponsor
80 Previous Clinical Trials
265,408 Total Patients Enrolled
George Clinical Pty LtdIndustry Sponsor
13 Previous Clinical Trials
19,277 Total Patients Enrolled
BayerIndustry Sponsor
2,277 Previous Clinical Trials
25,539,030 Total Patients Enrolled
Centre Hospitalier Régional Universitaire de NancyUNKNOWN
1 Previous Clinical Trials
2,293 Total Patients Enrolled
King Abdullah International Medical Research CenterOTHER
48 Previous Clinical Trials
118,519 Total Patients Enrolled
Sunil BadveStudy ChairThe George Institute
1 Previous Clinical Trials
3,600 Total Patients Enrolled
Martin GallagherStudy ChairThe George Institute

Media Library

Rivaroxaban (Anticoagulant) Clinical Trial Eligibility Overview. Trial Name: NCT03969953 — Phase 3
Cardiovascular Disease Research Study Groups: Rivaroxaban, Placebo
Cardiovascular Disease Clinical Trial 2023: Rivaroxaban Highlights & Side Effects. Trial Name: NCT03969953 — Phase 3
Rivaroxaban (Anticoagulant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03969953 — Phase 3
~769 spots leftby Jun 2027
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