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Study to Test BI 765845 for Patients with Heart Attack

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a new treatment for patients who have experienced a heart attack, also known as an acute myocardial infarction. The treatment being tested is called BI 765845, which is a solution given through an infusion, meaning it is administered directly into the bloodstream. The study will compare the effects of BI 765845 with a placebo to determine its effectiveness and safety.

The purpose of the study is to see if BI 765845 can help improve the condition of patients who have had a heart attack when used alongside the standard care they are already receiving. The trial will also explore the best dose of BI 765845 to use in future studies. Participants in the study will receive either BI 765845 or a placebo, and their progress will be monitored to assess the treatment's impact on their recovery.

During the study, participants will receive a single administration of the treatment and will be closely observed to ensure their safety and to gather information on how well the treatment works. The study aims to identify the most effective dose of BI 765845 for use in further research. This trial is an important step in developing new treatments for heart attack patients and could lead to improved outcomes for those affected by this condition.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the patient will have signed a consent form, confirming understanding and agreement to participate in the trial.
The patient must be at least 18 years old and have experienced symptoms of a heart attack within a specific timeframe before randomization.
Step 2
Randomization and initial assessment
The patient will be randomly assigned to receive either the investigational medication BI 765845 or a placebo. This process is double-blind, meaning neither the patient nor the researchers know which treatment is being administered.
An initial assessment will be conducted to evaluate the patient's condition and establish a baseline for future comparisons.
Step 3
Administration of medication
The patient will receive a single dose of the assigned treatment. BI 765845 is administered as a solution for infusion, while the placebo is designed to match this form.
The administration is performed intravenously, meaning the medication is delivered directly into a vein.
Step 4
Monitoring and follow-up
Following the administration, the patient will be monitored to assess the efficacy and safety of the treatment. This includes regular check-ups and evaluations of heart health.
The primary focus is on the severity of the heart attack and the patient's recovery progress.
Step 5
Completion of the study
The study is expected to conclude by March 2027. Throughout the trial, the patient's health and response to the treatment will be closely observed.
The data collected will contribute to understanding the effectiveness of BI 765845 and its potential use in future treatments for heart attack patients.

Who can join the trial?

6 criteria

Must be **18 years or older** (or the legal age according to local rules) at the time of signing the consent form.
Must have signed and dated a written consent form, either by the patient or an impartial witness, following international and local guidelines before joining the trial.
Participants can be **male or female** but must not be able to have children. Male participants must agree to use very effective birth control methods for at least 5 days after receiving the trial medication. Women who cannot have children include those who are 50 years or older and have not had a period for at least 1 year (not due to cancer treatment or breastfeeding), have confirmed early ovarian failure, have had both ovaries and fallopian tubes removed, have had a hysterectomy, have Turner syndrome, or were born without a uterus.
Must have experienced symptoms of **heart-related chest pain or heart attack** within a specific time before being randomly assigned to a treatment group:
- For Part A: Symptoms must have started between 3 and 8 hours before randomization.
- For Part B: Symptoms must have started between 1 and 12 hours before randomization.
- Other criteria may also apply.

Who cannot join the trial?

2 criteria

Patients who have had a recent **heart attack** (also known as **acute myocardial infarction**) cannot participate.
Patients who are part of a **vulnerable population** are not eligible. This means people who might need extra protection or care, like those with certain disabilities or conditions.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Responsive
Azienda Ospedaliera Ordine Mauriziano Di Torino
Turin, Italy
Responsive
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
Palermo, Italy
Responsive
Complexo Hospitalario Universitario De Vigo
Vigo, Spain

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Investigated drugs

BI 765845 is a medication being studied for its potential benefits in patients who have experienced an acute myocardial infarction, commonly known as a heart attack. The trial aims to evaluate how effective this medication is when given alongside the standard treatments that patients typically receive after a heart attack. Researchers are also looking at how safe and tolerable the medication is for patients. Additionally, the study is designed to understand how different doses of BI 765845 affect patients, with the goal of determining the best dose to use in future studies.

What is already known about the treatment

BI 765845 – This medication is administered as a single injection and is currently being studied in clinical trials for its potential use in treating acute myocardial infarction, commonly known as a heart attack. It is in the experimental phase, with ongoing research to determine its effectiveness and safety. The main therapeutic indication is to improve outcomes in patients who have experienced a heart attack. At the molecular level, BI 765845 works by targeting specific pathways involved in heart tissue repair and recovery. It is classified pharmacologically as an investigational drug, with studies focusing on its dose-response relationship to identify the optimal dosage for future trials.

Investigated diseases

Acute Myocardial Infarction – This condition, commonly known as a heart attack, occurs when blood flow to a part of the heart is blocked for a long enough time that part of the heart muscle is damaged or dies. The blockage is usually caused by a buildup of fat, cholesterol, and other substances, which form a plaque in the arteries that feed the heart. As the plaque breaks, a blood clot forms, which can completely block the blood flow. Symptoms often include chest pain, shortness of breath, and discomfort in other areas of the upper body. The progression of the disease can lead to significant damage to the heart muscle, affecting its ability to pump blood effectively. Immediate medical attention is crucial to restore blood flow and minimize heart damage.