Comparison of a low dose of the anticlotting drug apixaban with the standard dose of apixaban in patients with the heart rhythm disturbance known as atrial fibrillation who have undergone stenting treatment of their heart arteries and are intended to receive standard-dose apixaban along with another anticlotting drug, ticagrelor
This study looks at people who have an irregular heartbeat called atrial fibrillation and have recently had a heart stent put in. They are usually given two blood-thinning medicines, apixaban and ticagrelor, to prevent strokes and keep the stent clear. We want to find out if using a lower dose of apixaban, along with ticagrelor, could lead to less bleeding compared to the standard dose. We'll also check how well these different combinations work. This research might help us find a way to make treatment safer for patients in the future.
At a glance
What is this study about?
When someone has an irregular heartbeat called atrial fibrillation and has also had a heart stent fitted, doctors often prescribe two types of blood-thinning medicines. These medicines, like apixaban and ticagrelor, are very important because they help prevent serious problems such as strokes and blockages in the heart stent. However, all blood-thinning medicines come with a risk of bleeding.
This study aims to explore if a lower dose of apixaban, when taken alongside ticagrelor, can work just as well but cause less bleeding than the standard dose. By looking at bleeding risk and how effectively the blood is thinned, we hope to gather important information. This could lead to safer treatment options for patients in similar situations without reducing the protection against serious health issues.
The results of this study will help doctors understand more about combining these medications. This knowledge could guide future treatment decisions and potentially improve safety for many patients. The study is a 'Phase IV' trial, which means it's testing a treatment that is already approved, but looking at different ways to use it or understand its effects better in a real-world setting.
Key takeaways
- Compares two apixaban doses with ticagrelor for people with atrial fibrillation and heart stents.
- Aims to find out if a lower apixaban dose causes less bleeding.
- Involves taking assigned medication for about 4 weeks, followed by a visit and phone call.
- Researchers will check blood tests and bleeding time.
- Main risk is bleeding; lower dose might reduce this risk.
- Study is funded by Sheffield Hospitals Charity.
Who may be eligible?
You might be able to join this study if you are an adult, aged 18 or over. You must have had a heart stent put in within the last seven days and also have a history of an irregular heartbeat called atrial fibrillation, which requires long-term blood-thinning treatment. You should also be prescribed or already taking apixaban (5mg twice a day) and ticagrelor (90mg twice a day).
However, you won't be able to join if you have certain health conditions like active serious bleeding, a history of bleeding in the brain, or very poor kidney function. Also, if you're already taking other specific types of blood-thinning medication (besides apixaban and ticagrelor) or if you need surgery soon that would stop you from taking these medicines, you won't be able to take part.
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.
- Are you 18 years old or older?
- Did you have a heart stent put in within the last 7 days?
- Do you have atrial fibrillation and need long-term blood thinners?
- Are you prescribed or currently taking apixaban (5mg twice daily) and ticagrelor (90mg twice daily)?
- Do you have any active serious bleeding or a history of bleeding in the brain?
- Do you have very poor kidney function (eGFR <30 ml/min)?
What does participation involve?
If you decide to take part and sign a consent form, you will be randomly assigned to one of two groups. One group will take the standard dose of apixaban (5mg twice a day) along with ticagrelor (90mg twice a day). The other group will take a lower dose of apixaban (2.5mg twice a day) with the same dose of ticagrelor (90mg twice a day). You will continue taking these assigned medications until a study visit about 4 weeks later (26-28 days).
During this visit, you'll have a special skin bleeding test and blood tests to see how the medicines are affecting your blood. After this visit, you'll go back to taking your usual medications as recommended by your doctors. The research team will then contact you by phone a further 2 weeks later to check in. The study plans to run from September 2025 to February 2027.
Potential risks and benefits
Locations (1)
- Sheffield Teaching Hospitals NHS Foundation TrustCity onlySheffield, England
Common questions
What is atrial fibrillation?
Atrial fibrillation is a common type of irregular and often very fast heartbeat. It can increase your risk of stroke.
What is a heart stent?
A heart stent is a tiny mesh tube that doctors place in a blocked or narrowed heart artery to help keep it open and improve blood flow.
Why do I need two blood-thinning medicines?
For people with atrial fibrillation and a heart stent, two blood thinners are often used together to prevent both strokes and blockages in the stent.
What is the difference between apixaban and ticagrelor?
Both are blood-thinning medicines, but they work in slightly different ways to prevent blood clots. They are often used together for conditions like yours.
What will happen if I decide not to participate?
If you choose not to participate, your medical care will not be affected, and you will continue to receive the standard treatment your doctors recommend.
How to find out more
. Clinical Research & Innovation Office
Always speak to your GP or specialist before deciding to take part in a study.
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