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Study on Low Dose Rivaroxaban for Heart and Blood Vessel Disease in Patients with Advanced Kidney Disease or on Dialysis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called Rivaroxaban on people with advanced chronic kidney disease (CKD) who also have heart and blood vessel disease, known as cardiovascular disease. The study aims to see if taking a low dose of Rivaroxaban, which is a type of blood thinner, can help reduce the risk of serious heart-related events such as heart attacks, strokes, or problems with blood flow in the legs. Participants in the study will either receive Rivaroxaban or a placebo, which looks like the medication but does not contain the active ingredient.

The purpose of the study is to determine if Rivaroxaban can significantly lower the chances of cardiovascular death or other major heart-related issues in people with advanced CKD, including those who are on dialysis. Dialysis is a treatment that helps clean the blood when the kidneys are not working well. The study will involve taking the medication twice daily over a period of time, and participants will be monitored for any changes in their health related to heart and blood vessel conditions.

Throughout the study, researchers will keep track of various health outcomes to understand the potential benefits and risks of using Rivaroxaban in this group of patients. The study is expected to provide valuable information on whether this medication can be a safe and effective option for people with both advanced kidney disease and cardiovascular disease.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria such as age, kidney function, and cardiovascular risk factors.

    Informed consent is required to participate in the study.

  2. Step 2

    Medication administration

    Participants receive either Rivaroxaban 2.5 mg or a placebo. The medication is taken orally as a film-coated tablet.

    The dosage is 2.5 mg taken twice daily.

  3. Step 3

    Monitoring and follow-up

    Regular monitoring is conducted to assess the impact of the medication on cardiovascular health.

    Participants are observed for any events such as cardiovascular death, non-fatal heart attack, stroke, or peripheral artery disease.

  4. Step 4

    Completion of the study

    The study is estimated to conclude by March 2026.

    Final assessments are made to determine the effectiveness of the low dose Rivaroxaban in reducing cardiovascular risks.

Who can join the trial?

8 criteria

  • Must be able to give permission to participate in the study.
  • Must be at least 18 years old.
  • Must have kidney failure and be on **haemodialysis** or **peritoneal dialysis**. These are treatments that help clean the blood when the kidneys are not working well.
  • Alternatively, must have **chronic kidney disease (CKD) stage 4 or 5**. This means the kidneys are not working well, but the person is not yet on dialysis.
  • Must have a higher risk of heart and blood vessel problems, shown by at least one of the following:
  • History of **coronary artery disease (CAD)**, which is a problem with the blood vessels of the heart, or **peripheral arterial disease (PAD)**, which is a problem with blood vessels outside the heart and brain, or a type of stroke that is not caused by bleeding in the brain.
  • Having **diabetes mellitus**, which is a condition where the body has trouble controlling blood sugar levels.
  • Being 65 years old or older.

Who cannot join the trial?

10 criteria

  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients with a history of severe allergic reactions to the study medication or similar medications are excluded.
  • Patients with active bleeding or a high risk of bleeding are not eligible.
  • Patients with severe liver disease, which means the liver is not working well, cannot join the study.
  • Patients who have had a recent stroke, which is a sudden problem with the blood supply to the brain, are excluded.
  • Patients with a recent heart attack, which is when blood flow to the heart is blocked, cannot participate.
  • Patients who are currently using certain medications that might interfere with the study drug are not eligible.
  • Patients with a history of drug or alcohol abuse, which means using these substances in a harmful way, are excluded.
  • Patients who have participated in another clinical trial within the last 30 days cannot join this study.
  • Patients with any other medical condition that the study doctors think would make it unsafe for them to participate are not eligible.
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Investigated drugs

Rivaroxaban is a medication used in this clinical trial to see if it can help reduce the risk of serious heart and blood vessel problems. These problems include heart attacks, strokes, and issues with blood flow in the legs. The trial is focused on patients who have advanced kidney disease or are on dialysis, as they are at a higher risk for these cardiovascular issues. Rivaroxaban is being tested to see if it can provide benefits in these patients by lowering the chances of these events happening.

What is already known about the treatment

Rivaroxaban – This medication is administered orally in the form of tablets. It is currently being studied in clinical trials for its potential to improve cardiovascular outcomes in patients with advanced chronic kidney disease. The main therapeutic indication is to reduce the risk of cardiovascular events such as heart attack, stroke, and peripheral artery disease in these patients. Rivaroxaban works by inhibiting a specific protein involved in blood clotting, thereby reducing the formation of harmful clots. It is classified as an anticoagulant, specifically a direct oral anticoagulant (DOAC).

Investigated diseases

  • Chronic Kidney Disease

    This condition involves the gradual loss of kidney function over time. As the disease progresses, the kidneys become less effective at filtering waste and excess fluids from the blood. This can lead to a buildup of waste products in the body, causing symptoms such as fatigue, swelling, and high blood pressure. In advanced stages, kidney function may decline significantly, potentially requiring dialysis or a kidney transplant. The disease can also increase the risk of cardiovascular problems due to the strain on the heart and blood vessels. Chronic kidney disease often progresses slowly, and symptoms may not appear until significant damage has occurred.

  • Cardiovascular Disease

    This term encompasses a range of conditions affecting the heart and blood vessels. It often involves narrowed or blocked blood vessels, which can lead to heart attacks, chest pain, or strokes. As the disease progresses, it can cause symptoms such as shortness of breath, fatigue, and irregular heartbeats. Risk factors include high blood pressure, high cholesterol, smoking, and diabetes. Over time, cardiovascular disease can lead to serious complications, impacting overall health and quality of life. It is a leading cause of illness and can affect individuals differently based on various factors.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-512483-59-00Protocol codeTRACK_001Estimated enrolment2 000 patientsSponsorThe George Institute For Global Health

sourced from the EU Clinical Trials Register and site verification

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