AuthorisedTherapeutic use (Phase IV)Interventional

Optimal Antiplatelet Treatment to Achieve Stroke Avoidance and Fall in Bleeding Events following Left Atrial Appendage Closure (SAFE-LAAC). Comparative Health Effectiveness Randomized Trial – PILOT Study

This study, called SAFE-LAAC, is for people with an irregular heartbeat called atrial fibrillation who have had a procedure to close off their left atrial appendage. This procedure helps reduce the risk of stroke. Doctors want to find the best antiplatelet medicine (like aspirin or clopidogrel) to take after this procedure. They aim to prevent serious problems like strokes and heart attacks, while also keeping bleeding risks as low as possible. By comparing these medicines, the study hopes to improve how patients are cared for, making treatment safer and more effective for preventing future health issues.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy

Enrolment target

200

Start

16 Dec 2024

Atrial fibrillation

What is this study about?

This research study, called SAFE-LAAC, is looking into the best way to prevent strokes and other heart-related problems for people who have a common heart condition called atrial fibrillation. Atrial fibrillation causes an irregular heartbeat, which can lead to blood clots forming in a small pouch of the heart called the left atrial appendage. These clots can then travel to the brain and cause a stroke.

To reduce this risk, some people have a procedure to close off this left atrial appendage. After this procedure, it's important to take medicines that help prevent blood clots. This study wants to find out if standard blood-thinning medicines, like aspirin or a combination of aspirin and clopidogrel, are better at stopping strokes while keeping the risk of bleeding low. This is a "Phase IV" study, which means the medicines are already approved and safely used, but doctors are looking for the best way to use them together in this specific situation.

The main goal is to see if one treatment plan is more effective at preventing serious events like strokes, mini-strokes (TIAs), heart attacks, and even death, while also reducing the chance of moderate or severe bleeding. By understanding this better, doctors can provide clearer guidance on the best treatment after the left atrial appendage closure procedure, ultimately improving patient health and safety.

Key takeaways

Aims to find the best blood-thinning medicine after left atrial appendage closure.
Focuses on people with atrial fibrillation to prevent strokes.
Compares aspirin versus aspirin plus clopidogrel.
Measures how well treatments prevent strokes and how they affect bleeding.
Study medicines are already approved and safely used.
Participation helps future patients with atrial fibrillation.

Who may be eligible?

This study is open to both men and women who are 18 years old or older. There is no upper age limit, meaning older adults can also take part.

To be eligible, you must have atrial fibrillation and have recently had, or are about to have, a procedure to close your left atrial appendage. This is the main health condition the study is focusing on.

There might be other specific health requirements or conditions that would prevent someone from joining, which your doctor would discuss with you in detail.

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?
Do you have atrial fibrillation?
Have you recently had, or are you about to have, a left atrial appendage closure procedure?
Are you able to attend regular follow-up appointments?
Are you willing to take study medications as prescribed?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be assigned to take either aspirin alone or a combination of aspirin and clopidogrel. These are medicines you would take by mouth, often for a specific period after your left atrial appendage closure procedure.

You would have regular appointments with the study team. These appointments would involve health checks, asking about any symptoms you're having, and potentially blood tests to monitor your health and how the medicine is affecting you. The doctors would be closely monitoring you for any signs of stroke or bleeding.

The total duration of your participation in the study would depend on the study design, but generally, this kind of research involves follow-up for a period after starting the medication to see how well it works and if there are any side effects. Your doctor will explain the exact schedule and duration.

Potential risks and benefits

Taking part in this study may offer the potential benefit of closer monitoring of your health after your left atrial appendage closure procedure. You would also be contributing to important research that will help improve care for future patients. However, there are potential risks, mainly related to the medicines being studied: aspirin and clopidogrel can increase the risk of bleeding. While the study aims to find the best balance, there's always a chance of side effects. You are free to withdraw from the study at any time, for any reason, without it 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
Poland

Common questions

What is atrial fibrillation?

Atrial fibrillation is a common type of irregular and often very rapid heartbeat that can increase your risk of stroke.

What is the left atrial appendage closure procedure?

It's a procedure to close off a small pouch in your heart where blood clots can form, which helps reduce the risk of stroke for people with atrial fibrillation.

What are 'antiplatelet' medicines?

These are medicines, like aspirin and clopidogrel, that help prevent blood clots from forming, reducing the risk of strokes or heart attacks.

Will I know which medicine I'm taking?

This study compares different treatments, so you might be told which medicine you're taking, or it might be decided by chance to ensure a fair comparison. Your doctor will explain this.

What does a 'Phase IV' study mean?

It means the medicines being studied are already approved and widely used. This study is looking at the best way and combination to use them for a specific condition.