Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Randomised study for double-blind, placebo-controlled evaluation of BI 765845 on top of standard of care in patients with myocardial infarction

This research study is looking at a new medicine called BI 765845 for people who have just had a heart attack. The main goal is to find out if this new medicine, when given alongside the treatments doctors usually provide, can help reduce the amount of damage to the heart muscle. To do this, some participants will receive the new medicine and others will get a dummy medicine (placebo), without knowing which one they have. This helps researchers compare the effects fairly. This is an early-stage study (Phase II) to see if the treatment is promising and safe enough to be tested on more people in the future. The results will help doctors understand better ways to care for heart attack patients.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Boehringer Ingelheim International GmbH, Boehringer Ingelheim RCV GmbH & Co. KG, Boehringer Ingelheim Espana S.A.

Enrolment target

194

Start

30 Oct 2023

acute myocardial infarction

What is this study about?

This important study is designed for individuals who have recently experienced a heart attack. When someone has a heart attack, part of their heart muscle can be damaged because it doesn't receive enough blood. Doctors already have very good ways to treat heart attacks, but researchers are always looking for new treatments that could improve outcomes even further.

The main idea behind this study is to explore if a new medicine, called BI 765845, could help reduce the severity of this heart muscle damage. Researchers believe that by adding this new medicine to the standard care patients already receive, it might be possible to protect the heart even more. Reducing the damage can lead to better recovery and long-term health for heart attack patients.

This study is a 'Phase II' clinical trial, which means it's an early but crucial step in testing new medicines. It's about finding out if the new medicine is safe, and if it shows enough promise to be studied in larger groups of people. The information gathered will help doctors understand if BI 765845 has the potential to become a new treatment option for people recovering from a heart attack.

Key takeaways

This study tests a new medicine (BI 765845) for recent heart attack patients.
The goal is to see if it reduces heart muscle damage.
Participants receive either the new medicine or a dummy (placebo) alongside usual care.
It's an early-stage study to check safety and promise.
Open to adults 18 and over, both men and women.

Who may be eligible?

To be considered for this study, you must be at least 18 years old. There's no upper age limit, meaning older adults can also take part. The study is open to both men and women.

Because this study is specifically for people who have just had a heart attack, you would need to have experienced one recently to be eligible. The medical team will check details about your heart attack to make sure you meet the specific criteria for the study.

There might be other health conditions or medicines that would prevent someone from joining, but the study doctors will go through all of this with you carefully to determine if this study is a good fit for your individual situation.

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.

Have I recently had a heart attack?
Am I 18 years old or older?
Am I able to commit to regular hospital/clinic visits?
Am I comfortable with the idea of potentially receiving a placebo?
Am I willing to undergo additional tests like MRI scans?

Answer every question to see your result.

What does participation involve?

If you join this study, it would involve several visits to the hospital or clinic over a period of time. You would be given either the new study medicine (BI 765845) or a dummy medicine (placebo), along with your usual heart attack treatments. Neither you nor your study doctor would know which one you are receiving – this is a common practice to ensure unbiased results.

During your participation, you would have regular check-ups, which may include physical examinations, blood tests, and heart scans (like an MRI scan using a special dye called Gadovist to get clear images of your heart). These tests help the researchers understand how your heart is recovering and how you are responding to the treatment. The total duration of your involvement, including follow-up, would be fully explained by the study team.

Potential risks and benefits

Taking part in a clinical trial has potential benefits and risks. You might benefit from closer medical attention and potentially receive a new treatment that could improve your heart's recovery, though there's no guarantee the experimental medicine will be more effective than standard care. Potential risks could include side effects from the study medicine or the extra tests, such as discomfort from blood draws or reactions to the imaging dye. All known risks will be thoroughly explained. 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 (7)

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

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Unverified
Slovakia
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Unverified
Poland
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Unverified
Germany
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Unverified
Czechia
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Unverified
Hungary
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Unverified
Italy
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Unverified
Spain

Common questions

What is a 'heart attack' in this study?

A heart attack happens when blood flow to part of the heart is blocked, causing damage to the heart muscle. This study is for people who have recently experienced one of these events.

What does 'double-blind' mean?

It means that neither you nor your study doctor will know whether you are receiving the new medicine or the dummy medicine. This helps ensure the study results are fair and accurate.

What is 'standard of care'?

Standard of care refers to the usual, accepted treatments that doctors currently use for heart attack patients. In this study, the new medicine is given *in addition* to these established treatments.

Will I have to pay to be in the study?

No, all study-related treatments, tests, and visits are provided at no cost to you.

What is a 'Phase II' study?

Phase II is an early stage of testing a new medicine. It aims to see if the medicine is safe and effective enough to be studied in larger groups of people later on.