Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Vitamin-K-Antagonist and direct thrombin inhibitor Dabigatran for thrombus resolution in left ventricular thrombus after acute STEMI: an open label randomized controlled multicenter Phase-II study

This research study is for people who have had a specific type of heart attack (STEMI) that has led to a blood clot forming in the main pumping chamber of their heart (left ventricle). After a heart attack, blood clots can sometimes form in the heart and then travel to other parts of the body, like the brain, causing a stroke. This study aims to find out if a newer medication, dabigatran (Pradaxa), is better or safer than older, commonly used medicines (like warfarin, known as Marcumar in some regions) at dissolving these heart clots and preventing strokes. Researchers will compare how well these drugs work and check for any side effects, especially bleeding, over three months and then for a year.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Medical University Of Graz

Enrolment target

116

Start

31 May 2024

STEMI (ST elevation myocardial infarction)Left ventricular thrombosis

What is this study about?

When someone has a severe type of heart attack (called a STEMI), sometimes a blood clot can form inside the heart's main pumping chamber. This clot is a serious concern because pieces of it can break off and travel through the bloodstream to other parts of the body, potentially causing a stroke. Strokes can lead to lasting problems with movement, speech, or thinking, so preventing them is very important.

Doctors often give medicines to thin the blood and help dissolve these clots, or stop new ones from forming. This study is like a test to see if a newer blood-thinning medicine called dabigatran works better than a more traditional one (like those similar to warfarin, sometimes called Marcumar). They want to find out which medicine is more effective at making heart clots disappear and preventing strokes, while also looking for side effects like bleeding.

By comparing these medicines, researchers hope to improve treatment for people who develop heart clots after a heart attack. The results could help doctors decide the best way to protect patients from strokes and other problems in the future. It's about finding safer and more effective ways to care for people recovering from heart attacks.

Key takeaways

The study compares two blood-thinning medicines for heart clots after a serious heart attack.
It aims to find out which medicine (dabigatran or warfarin-like) is better at dissolving clots and preventing strokes.
Participation involves taking a study medicine for 3 months and being monitored by doctors for a year.
All adults (18+) who have had a specific heart attack and developed a heart clot may be eligible.
There's a risk of bleeding due to blood-thinning medicines, which will be closely monitored.

Who may be eligible?

This study is looking for adults aged 18 or older, both men and women. You might be eligible if you've recently had a specific type of heart attack (called a STEMI) and, as a result, developed a blood clot in the main pumping chamber of your heart (the left ventricle).

There might be other health conditions or medications that would prevent you from taking part, to ensure your safety and the accuracy of the study results. For example, if you have certain kidney problems, significant bleeding issues, or are already taking other specific blood thinners that are incompatible with the study drugs, you may not be able to join.

Your doctor will carefully check your medical history, current health, and other medications to see if this study is suitable for you. They will discuss all the requirements 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?
Have you recently had a specific type of heart attack (STEMI)?
Has your doctor told you that you have a blood clot in your heart's main pumping chamber (left ventricle)?
Are you able to take blood-thinning medicines safely?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be randomly assigned to receive either dabigatran or a warfarin-like medicine (phenprocoumon, sometimes known as Marcumar), along with other standard heart medications like clopidogrel and aspirin. This means you wouldn't get to choose which study drug you receive.

For the first three months, you would take your assigned study medication and have regular check-ups, which include appointments and possibly blood tests or scans like an MRI of your brain. These check-ups are to see how well the medicine is working to dissolve the blood clot in your heart and to check for any side effects, particularly if you experience any signs of a stroke or bleeding.

After these initial three months, doctors will continue to monitor your health for a full year. This follow-up will involve further checks to track your overall health, the long-term effects of the treatment, and any new events such as strokes or bleeding episodes. The total duration of active study treatment is 3 months, followed by 9 months of observational follow-up, making it a year-long commitment.

Potential risks and benefits

Taking part in this study could potentially offer you access to a new treatment approach that may be more effective. However, there are potential risks, primarily from the blood-thinning medicines, which can increase the chance of bleeding, ranging from minor bruises to more serious internal bleeding. You will be closely monitored for any 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
Austria

Common questions

What is a 'STEMI heart attack'?

It's a very serious type of heart attack where a major blood vessel supplying the heart is completely blocked.

What is a 'left ventricular thrombus'?

It's a blood clot that forms inside the main pumping chamber of your heart after a heart attack.

What is dabigatran (Pradaxa) and phenprocoumon (Marcumar)?

These are both medicines that thin your blood to prevent or treat blood clots. Dabigatran is a newer medicine, while phenprocoumon is an older, commonly used type similar to warfarin.

Why is it important to prevent a stroke?

A stroke can cause lasting damage to the brain, affecting things like movement, speech, and memory, so preventing it is crucial.

Will I get to choose which medicine I receive?

No, you would be randomly assigned to receive either dabigatran or the warfarin-like medicine, similar to flipping a coin, to ensure a fair comparison.