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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years or trial closure
Awards & highlights
TRACK 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.Check my eligibility
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.See study design
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.
TRACK Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I am 65 years old or older.
Select...
I have severe kidney failure or am on dialysis.
Select...
I have diabetes.
Select...
I have a history of heart disease, peripheral artery disease, or a specific type of stroke.
TRACK Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years or trial closure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years or trial closure
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Risk of Major Adverse Cardiac Event (MACE)
Secondary outcome measures
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 moreOther outcome measures
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
TRACK 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
76 Previous Clinical Trials
263,854 Total Patients Enrolled
George Clinical Pty LtdIndustry Sponsor
13 Previous Clinical Trials
19,292 Total Patients Enrolled
BayerIndustry Sponsor
2,240 Previous Clinical Trials
25,330,777 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a mechanical or prosthetic heart valve that requires medication to prevent blood clots.I am 18 years old or older.I need or cannot take blood thinners.I have received a kidney transplant and it is working, or I am scheduled for one.If you live outside Europe, you are pregnant, planning to become pregnant, or breastfeeding. If you live in Europe, you are not in a postmenopausal state, which means you have had no periods for 12 months without a medical reason.I have not had any major bleeding or significant active bleeding recently.You have had a bad reaction to rivaroxaban in the past.I am 65 years old or older.Your blood pressure is not well controlled and is very high (systolic BP ≥180 mm Hg or diastolic BP ≥110 mm Hg).I am at high risk for heart problems.I am not taking strong drugs that affect liver enzymes or drug transporters.I have not had a stroke in the last month.Your hemoglobin level is less than 90 grams per liter, or your platelet count is less than 100 billion per liter.I do not have severe liver disease or very high ALT levels.I have a high risk of bleeding due to a blood disorder.I have severe kidney failure or am on dialysis.I am currently taking blood thinning medication and cannot stop.I have had a stroke caused by bleeding or a small vessel blockage.I have a condition that could cause serious bleeding.My heart is very weak (ejection fraction <30%) or I have severe heart symptoms.I understand and can follow the study's requirements.I have diabetes.I have a history of heart disease, peripheral artery disease, or a specific type of stroke.
Research Study Groups:
This trial has the following groups:- Group 1: Rivaroxaban
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the antecedents of this research?
"Rivaroxaban 2.5 Mg Oral Tablet has been the subject of 61 clinical trials since 2015. The first Phase 3 drug approval stage trial, sponsored by Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma, was completed with 2180 patients. Since then, 18442 additional studies have been completed."
Answered by AI
Are you still recruiting people for this research?
"From what is indicated on clinicaltrials.gov, this study is looking for qualified individuals. The posting for the clinical trial was made on December 14th 2020, with the most recent edit being on August 8th 2022."
Answered by AI
What are the risks associated with Rivaroxaban 2.5 Mg Oral Tablet?
"There is some prior clinical data that suggests Rivaroxaban 2.5 Mg Oral Tablet is effective, which is why it received a score of 3."
Answered by AI
What are the usual indications for Rivaroxaban 2.5 Mg Oral Tablet?
"Rivaroxaban 2.5 Mg Oral Tablet is a medication used to treat venous thromboembolism and other conditions such as chronic coronary artery disease, deep vein thrombosis, and cerebrovascular accident."
Answered by AI
How many people suffering from this disease are being given the chance to participate in this study?
"That is correct. The trial, which was originally posted on December 14th 2020, is still active and looking for 2000 participants at 2 sites."
Answered by AI
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