AuthorisedPhase III and phase IV (Integrated)Interventional

Strategy To Optimize PeriproCeduraL AnticOagulation in Structural Transseptal Interventions (STOP CLOT Trial)

The 'STOP CLOT' study (short for Strategy To Optimize PeriproCeduraL AnticOagulation in Structural Transseptal Interventions) is exploring the best way to give blood-thinning medicines around the time of certain heart procedures. These procedures include TEER, which helps treat leaky heart valves, and operations to close off a part of the heart called the left atrial appendage. The main goal is to find the safest and most effective approach to prevent serious problems like strokes, heart attacks, or new blood clots forming during or shortly after these procedures. Researchers will be looking closely for any new blood clots and other complications to make sure patients have the best possible outcomes.

At a glance

Status

Authorised

Phase

Phase III and phase IV (Integrated)

Sponsor

Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy

Enrolment target

410

Start

09 Dec 2024

periprocedural anticoagulant treatment in patients treated with TEER or transcatheter left atrial appendage closure surgery

What is this study about?

This study, called 'STOP CLOT', is looking at how best to give medicines that thin the blood during and right after specific heart procedures. These procedures are often done to help with certain heart conditions. One type is called TEER, which helps fix a leaky heart valve. The other is a procedure to close off a small pouch in the heart called the left atrial appendage, which can help prevent strokes in some people.

The main aim of the study is to find out which way of using these blood-thinning medicines works best to prevent problems. These problems could include serious events like a stroke, a heart attack, or new blood clots forming. The researchers will be carefully checking how patients are doing after their procedure, looking for things like new clots in the heart or new spots on a brain scan that could suggest a tiny stroke.

By understanding the best way to use these medications, doctors hope to make these important heart procedures even safer and reduce the risk of complications for patients in the future. This research is about improving patient care and making sure people have the best possible start to their recovery.

Key takeaways

The 'STOP CLOT' study aims to improve safety during specific heart procedures.
It tests different ways of using blood-thinning medicines.
The goal is to reduce serious problems like strokes and blood clots.
It focuses on TEER and left atrial appendage closure operations.
Your health will be closely monitored for about a month after your procedure.

Who may be eligible?

This study is looking for adults who are at least 18 years old. There's no upper age limit, so people of all adult ages can take part. Both men and women are welcome to participate in this research.

To be considered for the study, you would need to be scheduled for one of two specific heart procedures. These are either a TEER procedure, which helps fix a leaky heart valve, or a procedure to close off a small pouch in your heart called the left atrial appendage. The study focuses on how blood-thinning medicines are used around the time of these particular operations.

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?
Are you scheduled for a TEER procedure?
Are you scheduled for a left atrial appendage closure procedure?
Are you comfortable with receiving injectable medications?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive one of the specific blood-thinning treatments being tested around the time of your heart procedure. This would involve medications like saline solution (which is just salty water) or heparin, a common blood thinner, given as injections. Doctors would carefully monitor your health during the procedure and for about 30 days afterwards. You would have your usual checks from the medical team, and they might do some extra tests, like detailed scans of your heart during the procedure and brain scans a few days later, to check for any new clots or problems. The entire follow-up period for the main part of the study lasts for about 30 days after your heart procedure.

Potential risks and benefits

Taking part in any study has potential benefits and risks. You might not directly benefit from being in this study, but the information gathered could help improve care for future patients undergoing similar heart procedures. The main risks are related to the blood-thinning medications themselves, which can increase the chance of bleeding, from minor bruising to more serious bleeding complications. There's also a small chance of developing blood clots, which the study aims to prevent. You will be closely monitored for these risks. Please remember that participation is completely voluntary, and you can withdraw from the study at any time without affecting your 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 the 'STOP CLOT' study about?

It's a study looking for the best way to use blood-thinning medicines during certain heart operations to prevent problems like blood clots and strokes.

What kind of heart procedures are included in this study?

The study involves procedures like TEER for leaky heart valves, and operations to close off a part of the heart called the left atrial appendage.

What are 'blood-thinning medicines'?

These are medicines, like heparin, that help prevent blood clots from forming. They are often given as injections.

What are the key things doctors are looking for?

Doctors are checking for serious issues like strokes, heart attacks, or new blood clots forming during or shortly after the procedure.

How long does the study last for individual participants?

The main part of the study involves monitoring you for about 30 days after your heart procedure.