Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

AntiCoagulation versus AcetylSalicylic Acid after Transcatheter Aortic Valve Implantation

This important study is investigating which blood-thinning medicines work best for people who have recently had a heart valve replacement procedure, specifically for a condition called aortic stenosis. This procedure, often done through a keyhole, helps a narrowed heart valve. After surgery, it's crucial to prevent blood clots, but also to avoid excessive bleeding. The study is comparing several newer blood thinners (Rivaroxaban, Apixaban, Edoxaban) against aspirin to see which is better at preventing issues like blood clots and bleeding. Researchers are looking closely at how these medicines affect the new heart valve and your overall health, aiming to find the safest and most effective treatment options for patients in the long term.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Oslo University Hospital HF

Enrolment target

360

Start

23 Oct 2024

Aortic stenosis

What is this study about?

This study is all about helping people who have had a special heart operation called a Transcatheter Aortic Valve Implantation (TAVI). This operation is for a condition called aortic stenosis, where one of the main valves in your heart becomes stiff and narrow. The TAVI procedure helps to replace this valve, improving blood flow. After a TAVI, it's really important to prevent blood clots forming, which can lead to serious problems like strokes.

Currently, there are different ways doctors try to prevent these clots, often using medicines that make your blood less likely to clot – sometimes called 'blood thinners'. This study wants to find out which of these medicines is the most effective and safest combination for patients. They are comparing several newer blood thinners, such as Rivaroxaban, Apixaban, and Edoxaban, against a commonly used medicine, Aspirin. They want to see which one works best to prevent problems like blood clots while also keeping the risk of bleeding as low as possible.

Researchers will be looking very closely at how the new heart valve works, how patients feel, and if there are any serious problems like strokes or heart attacks. They're also keen to understand the long-term effects over 5 and even 10 years, to make sure patients continue to do well. The aim is to give doctors clear information so they can choose the very best treatment for people who have had this life-changing heart valve operation.

Key takeaways

This study compares different blood thinners after a keyhole heart valve replacement (TAVI) for aortic stenosis.
The goal is to find the safest and most effective medicine to prevent blood clots and minimise bleeding.
It's looking at newer blood thinners against aspirin.
Researchers will monitor how the new heart valve works and your overall health long-term.
It aims to improve treatment decisions for TAVI patients.
All adults who have had a TAVI procedure might be able to participate.

Who may be eligible?

This study is open to both men and women of all adult ages who have recently undergone a specific heart valve replacement procedure called Transcatheter Aortic Valve Implantation (TAVI).

To be considered, you would need to have received a diagnosis of aortic stenosis, which is a narrowing of your heart's main valve, and have had the TAVI procedure to treat it. The research team will review your medical history to make sure taking part is safe and suitable for you, considering your overall health.

It's important to remember that only people who meet all the specific requirements set by the study doctors will be able to take part. Your medical team can help you understand if this study might be an option 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.

Have you recently had a TAVI (Transcatheter Aortic Valve Implantation) procedure?
Did you have the TAVI because of a condition called aortic stenosis?
Are you an adult of any age?
Are you willing to take study medications and attend regular check-ups?
Are you able to provide your informed consent to participate?

Answer every question to see your result.

What does participation involve?

If you join this study, you would be given one of the study medications (either a newer blood thinner like Rivaroxaban, Apixaban, or Edoxaban, or Aspirin) to take regularly, as directed by the study doctors. You would have regular visits to the clinic for check-ups, which might include having blood tests, heart scans (like echocardiograms), and answering questions about how you're feeling and your general health. These visits are important for the doctors to monitor your health and how the medication is working. You would be followed very closely for a period after your heart procedure, and potentially over the long term (up to 5 or even 10 years) to understand the full effects of the treatment. The total duration of your active participation, including follow-up, will be clearly explained by the study team.

Potential risks and benefits

Taking part in this study could offer carefully monitored new treatments that might be more effective than current approaches, potentially improving your long-term health after your heart valve procedure. However, as with any medical treatment, there are potential risks, mainly related to bleeding or clotting with blood-thinning medicines, which the study will monitor very closely. You will be fully informed of all known risks before deciding to take part, and you have the right to withdraw from the study at any time, for any reason, without this affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Norway

Common questions

What is Aortic Stenosis?

Aortic stenosis is a condition where one of the main valves in your heart, called the aortic valve, becomes stiff and narrow. This makes it harder for your heart to pump blood around your body.

What is a TAVI procedure?

TAVI stands for Transcatheter Aortic Valve Implantation. It's a special keyhole procedure to replace a narrowed aortic heart valve without open-heart surgery.

What are 'blood thinners'?

Blood thinners are medicines that help prevent blood clots from forming in your blood vessels. They are very important after certain heart procedures but can also increase the risk of bleeding.

Why is this study important?

This study is important because it aims to find the safest and most effective blood-thinning medicine for people who have had a TAVI, helping to prevent serious problems like strokes and improving long-term health.

Will I know which medicine I'm getting?

In many studies like this, patients are randomly assigned to a treatment group, and often neither you nor your doctor will know which specific medicine you are receiving. This helps make the study results fair.