AuthorisedTherapeutic use (Phase IV)Interventional

A Multicentre, Randomized Trial of Catheter-directed thrombolysis in intermediate-high risk acute pulmonary embolism (PRAGUE-26)

This research, called PRAGUE-26, is studying a new way to treat a serious condition called a pulmonary embolism (PE), which is a blood clot in the lungs. Specifically, it's for patients with a 'medium-high risk' PE, meaning it's quite serious. The study is comparing a medication called Actilyse, given directly into the clot using a thin tube (catheter), with the usual treatments. Researchers want to see if this targeted approach can reduce the risk of dying, stop the clot from coming back, or prevent the heart and lungs from getting worse within the first week. They will also look at longer-term effects over 30 days and even up to 12 months, including any side effects like bleeding, and how well people recover overall.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Fakultni Nemocnice Kralovske Vinohrady

Enrolment target

558

Start

02 Oct 2024

intermediate-high risk acute pulmonary embolism

What is this study about?

This study is called PRAGUE-26, and its main goal is to find better ways to treat a serious condition known as a pulmonary embolism (PE). A PE happens when a blood clot travels to the lungs and blocks blood flow, which can be very dangerous. This particular study focuses on patients who have a 'medium-high risk' PE, meaning their symptoms are significant enough to warrant careful treatment. Researchers are testing a specific medicine called Actilyse. Instead of giving it through a normal drip into the arm, this study uses a special thin tube, called a catheter, to deliver the medicine directly to the blood clot in the lung. This approach aims to dissolve the clot more effectively and quickly.

The main things the researchers want to find out are whether this direct treatment can reduce the risk of deaths, stop new clots from forming, or prevent the heart and lungs from getting worse within the first 7 days after treatment. They are also carefully watching for any problems, like bleeding, which can sometimes happen with powerful clot-dissolving medicines. By comparing this new way of giving the medicine to the standard treatments, the study hopes to understand if it offers a safer and more effective option for people with this type of challenging blood clot.

Beyond the first week, the study will continue to follow participants for up to a year, and some measures will even be taken up to two years. They will be looking at how well people recover, how long they need to stay in hospital, and how their hearts and lungs are working in the long run. This thorough approach helps ensure they understand all the potential benefits and risks of this treatment. It's a 'Phase IV' study, which means the general treatment (using Actilyse to dissolve clots) is already known, but this study is looking at a new, more targeted way of giving it and gathering more information on its real-world effects and safety.

Key takeaways

This study compares a new way of giving clot-dissolving medicine to standard treatment for serious lung clots.
It uses a thin tube to deliver medicine directly into the clot.
Researchers will check how well it works and if it causes fewer problems than usual care.
It's for people aged 18 and over with a 'medium-high risk' blood clot in their lungs.
Participation involves random assignment to treatment and follow-up for a year or more.
You'll be closely monitored for both benefits and potential side effects like bleeding.

Who may be eligible?

To take part in this study, you would need to be at least 18 years old. Importantly, you would be invited to participate if you have been diagnosed with a 'medium-high risk acute pulmonary embolism'. This means you currently have a blood clot in your lungs that doctors consider quite serious, and you've recently been diagnosed.

The study is open to both men and women. The medical team would carefully check your health and specific condition against a full list of detailed criteria to make sure the study is right and safe for you. These criteria are in place to protect your safety and ensure the study results are as clear as possible.

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 been diagnosed with a 'medium-high risk' blood clot in your lungs (acute pulmonary embolism)?
Are you ready to potentially receive either a targeted treatment or standard care, decided by chance?
Are you willing to attend follow-up appointments and tests over a period of up to two years?

Answer every question to see your result.

What does participation involve?

If you were to take part in this study, the first step would be 'randomization'. This means a computer would randomly assign you to receive either the specific 'catheter-directed thrombolysis' treatment (where the medicine Actilyse is given directly into the clot via a thin tube) or the usual standard care for your condition. You wouldn't get to choose which group you are in, just like flipping a coin, to ensure the study is fair.

After your treatment, the research team would closely monitor your health, especially within the first 7 days, to see how your body responds. This would involve checks for things like how your heart and lungs are doing, and whether the clot is improving. You would have follow-up appointments and tests at specific times, including after 30 days, and then periodically up to 12 months, and for some checks even up to 24 months. These might include scans like echocardiograms (to look at your heart) and tests to see how well you can move around, like a 6-minute walk test. They would also keep an eye out for any new problems or side effects throughout this period. The overall duration you'd be involved in the study's follow-up could be up to two years.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. You might benefit from receiving a treatment that could be more effective for your specific condition. The information learned from your participation could also help future patients with similar blood clots. However, there are potential risks, such as side effects from the medication like bleeding, or complications related to the procedure itself. The research team would discuss all potential risks and benefits in detail with you, and you would be closely monitored throughout the study. Remember, your participation is completely voluntary, and you have the right 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.

—
Unverified
Czechia

Common questions

What is a 'pulmonary embolism'?

A pulmonary embolism is a serious medical condition where a blood clot gets stuck in an artery in your lungs, blocking blood flow. It can be very dangerous.

What does 'intermediate-high risk' mean?

This means your blood clot in the lung is serious enough that doctors are concerned, but not immediately life-threatening in the same way as a 'high-risk' clot. It still needs careful and effective treatment.

What is Actilyse?

Actilyse is a medicine often called a 'clot-buster'. It's designed to dissolve blood clots in your body.

What does 'catheter-directed thrombolysis' involve?

This is a procedure where doctors use a thin, flexible tube (catheter) to deliver clot-dissolving medicine directly to where the blood clot is in your lung, aiming to target it more effectively.

How long would I be followed up if I took part?

You would be followed very closely in the first week, then at 30 days, and then periodically up to 12 months, and for some specific checks, even up to 24 months.