TRACK - Treatment of cardiovascular disease with low dose Rivaroxaban in Advanced CKD.
People with advanced chronic kidney disease have a much higher risk of developing heart and circulation problems, such as heart attacks, strokes, or poor blood flow to the legs. Rivaroxaban is an approved medicine that thins the blood to stop harmful clots from forming. This clinical trial, called TRACK, is investigating whether taking a low dose of rivaroxaban can safely lower these heart and blood vessel risks in people living with severe kidney disease. In this study, participants are randomly chosen to take either a low-dose rivaroxaban tablet or a matching dummy tablet (placebo) once or twice daily alongside their usual care. Researchers will monitor both groups closely over time to see whether the treatment reduces major heart problems and to check for any unwanted side effects, particularly bleeding.
At a glance
What is this study about?
The kidneys and the heart work closely together. When kidneys become damaged over a long period, known as chronic kidney disease, the heart and blood vessels often come under extra strain. Because of this, people with advanced kidney disease have a much higher chance of experiencing heart attacks, strokes, or severe circulation problems in their legs.
Rivaroxaban is a well-known blood-thinning medicine. Doctors already use it to treat and prevent blood clots in other conditions. However, finding the right balance for people with advanced kidney disease can be tricky because blood thinners can increase the risk of bleeding. The TRACK trial aims to find out if using a specially chosen low dose provides strong protection for the heart without causing dangerous bleeding.
During this Phase III trial, researchers will compare rivaroxaban against a placebo, which looks identical but contains no active medicine. By comparing the two groups, doctors can clearly see whether rivaroxaban truly makes a difference. The results could help change medical guidelines and offer better protection for people living with kidney illness across the UK.
Key takeaways
- The TRACK trial tests low-dose rivaroxaban to prevent heart attacks, strokes, and circulation problems in people with advanced kidney disease.
- Participants take either the active blood thinner or a dummy pill (placebo) alongside standard care.
- The study is for adults aged 18 and older with advanced chronic kidney disease.
- The main risk to be aware of is an increased chance of bleeding and bruising.
- Taking part is entirely voluntary, and you can withdraw at any time without changing your usual care.
Who may be eligible?
This study is open to adults aged 18 and older who have been diagnosed with advanced chronic kidney disease and are also at higher risk of heart problems or blood vessel disease. Both men and women can join.
To take part, your kidneys must be working at a significantly reduced level, but you must still be well enough to safely participate in a clinical trial. The study team will look closely at your past medical history, your current kidney function, and any existing heart or circulation issues.
You might not be able to join if you already take certain strong blood-thinning medicines, have had serious problems with bleeding in the past, or have other medical conditions that would make taking a blood thinner unsafe. Your kidney specialist will review your full medical details before confirming if the trial is right for you.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- I am aged 18 or older.
- A doctor has told me that I have advanced chronic kidney disease.
- I have a history of heart or circulation problems, or my doctor says I am at risk of them.
- I do not have an active medical condition that causes serious bleeding.
- I am able and willing to attend regular clinic check-ups and take a daily study tablet.
What does participation involve?
If you take part, you will be randomly assigned by a computer to take either a low-dose rivaroxaban tablet (2.5 mg) or a matching dummy tablet. Neither you nor your doctor will know which one you are receiving. You will take this tablet by mouth as instructed, on top of your normal daily medicines.
You will need to attend regular hospital or clinic appointments so the research team can check on your health. These visits usually involve standard health checks, such as blood pressure measurements, routine blood tests to check your kidney function, and discussions about how you are feeling. The study team will also ask about any symptoms or unexpected health events. Participation typically lasts for a few years, during which you will have scheduled follow-up visits and phone calls to track your progress.
Potential risks and benefits
Locations (3)
- —UnverifiedGermany
- —UnverifiedBelgium
- —UnverifiedFrance
Common questions
What is rivaroxaban?
Rivaroxaban is an anticoagulant, commonly called a blood thinner. It works by stopping blood clots from forming inside your veins and arteries.
What is a placebo and why is it used?
A placebo is an inactive tablet that looks and tastes identical to the real medicine. It allows doctors to fairly compare results and prove whether the active medicine really works.
Will this trial cure my kidney disease?
No, this trial is not designed to cure kidney damage. Its goal is to protect your heart and blood vessels from serious problems linked to kidney disease.
Can I carry on taking my usual medicines?
In most cases, yes. The study team will check all your regular medicines beforehand to make sure they do not interfere with the trial medication.
What happens if I decide to leave the trial early?
You can leave the study at any time. Your normal medical care will continue as usual, and your doctors will discuss the best treatment plan for you.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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