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AuthorisedTherapeutic use (Phase IV)Interventional

The effect of early Landiolol in patients with ST-elevation acute coronary syndrome undergoing primary percutaneous coronary intervention – A prospective, randomized, double- blinded, placebo controlled, phase IV pilot trial (STEMILAND-1)

This research, called STEMILAND-1, is investigating a new way to help people who have had a very serious type of heart attack. This kind of heart attack is caused by a completely blocked artery, and patients need emergency treatment to clear it. The study is testing a medicine called Landiolol, which is given through a drip (IV infusion). Doctors want to find out if giving Landiolol soon after the emergency treatment can reduce problems like irregular heartbeats or other heart issues in the 24 hours that follow. Half the patients will receive Landiolol, while the other half will receive a dummy treatment (placebo) to fairly compare the effects. Researchers are carefully monitoring participants to understand the medicine's potential benefits and side effects.

At a glance

Status
Authorised
Phase
Therapeutic use (Phase IV)
Sponsor
Medical University Of Vienna
Enrolment target
60
Start
14 Dec 2025

What is this study about?

Imagine you've had a very serious type of heart attack where one of the main arteries supplying blood to your heart gets completely blocked. This is called a 'ST-elevation acute coronary syndrome', and it's a medical emergency. Emergency treatment, often involving a procedure to open up the blocked artery, is crucial. This study, called STEMILAND-1, is looking into whether providing a specific medicine, Landiolol, very early on after this emergency treatment can make a difference.

The main aim of this study is to see if patients can successfully receive Landiolol continuously for 24 hours after their emergency heart attack treatment. Beyond that, the researchers are deeply interested in whether Landiolol can help prevent common heart problems that can occur shortly after a heart attack. These include issues like irregular heartbeats (which can be dangerous), or significant changes in blood pressure or heart function. They will be checking various heart markers and taking many measurements to understand how the heart is recovering.

To make sure the study is fair and accurate, some patients will receive Landiolol through a drip, while others will receive a 'dummy' treatment (a placebo) that looks exactly the same but contains no medicine. Neither the patient nor their doctors will know who is getting which treatment until the study is over. This helps to ensure that any observed effects are genuinely due to the medicine and not just other factors. The information gathered from this study will help doctors understand if Landiolol could become a routine part of care for people after this type of serious heart attack.

Key takeaways

  • This study is for adults who've had a serious heart attack needing emergency artery-opening treatment.
  • It tests a medicine called Landiolol given through a drip for 24 hours.
  • The main aims are to see if the medicine can be given without interruption and if it helps prevent heart problems like irregular beats.
  • Participation involves close monitoring for 24 hours and follow-up for 90 days.
  • Some patients will get Landiolol, others a dummy treatment; neither you nor your doctor will know which until the study ends.

Who may be eligible?

To join this study, you would need to be an adult, 18 years of age or older, and have recently experienced a specific type of serious heart attack called ST-elevation acute coronary syndrome. This means your heart attack was caused by a completely blocked artery, and you received emergency treatment to clear it.

There are certain health conditions or situations that might prevent someone from taking part, even if they meet the basic criteria. These could be other severe illnesses, certain medications you're already taking, or specific heart problems that could make the study medicine unsafe for you. The study team will review your medical history very carefully to ensure it's safe for you to participate.

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.

  1. Are you 18 years old or older?
  2. Have you recently experienced a serious heart attack where an artery was completely blocked?
  3. Did you receive emergency treatment to open that blocked artery?
  4. Are you able to stay in the hospital for close monitoring for at least 24 hours?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the study medicine (either Landiolol or the dummy treatment) through a drip directly into your vein for 24 hours. The main goal for us is to see if the medicine can be given continuously for this whole period without significant breaks. During this time, and for a period afterwards, the study team will be carefully monitoring your heart using ECGs (heart tracings) at several specific times (such as 6, 12, 18, and 24 hours). They will also take blood samples to check various heart markers and will be observing your blood pressure and overall condition very closely.

Beyond the initial 24 hours, the team will continue to track your health for 90 days. During this follow-up period, they will be looking for any signs of further heart problems, hospital readmissions, or other important health events. This helps us understand the longer-term effects of the treatment. The total duration of your participation in the study, from receiving the infusion to the final follow-up, would be around 90 days, with the most intensive monitoring in the first 24 hours.

Potential risks and benefits

Participating in research always involves potential benefits and risks. You might not directly benefit from being in this study, but your involvement could help future patients who suffer from similar heart conditions. The study medicine, Landiolol, can have side effects, such as a drop in blood pressure or a slow heartbeat, which is why your health will be carefully monitored throughout the treatment. There's also a chance of allergic reactions or other unexpected side effects. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

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

Common questions

What is Landiolol?

Landiolol is a medicine given through a drip (intravenously) that affects the heart. This study is testing if giving it early after a heart attack can help prevent further problems.

What is a 'dummy treatment' (placebo)?

A placebo is a substance that looks exactly like the study medicine but doesn't contain any active drug. It helps researchers fairly compare the real medicine's effects.

How long will I be in the study?

You'll receive the study medicine for 24 hours, and then your health will be followed up for a total of 90 days from the start of the study.

Will I know if I'm getting the real medicine?

No, this is a 'double-blind' study, meaning neither you nor your doctors will know if you're getting Landiolol or the placebo until the study is finished.

What is the main thing the study wants to find out?

The study primarily wants to see if we can successfully give Landiolol continuously for 24 hours to heart attack patients, and secondly, if it helps reduce problems like irregular heartbeats after treatment.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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