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Study on the Effects of Zalunfiban for Patients with ST-Elevation Myocardial Infarction (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 medication called Zalunfiban in patients who have experienced an acute heart attack, specifically a type known as ST-elevation myocardial infarction (STEMI). STEMI is a serious condition where a part of the heart muscle is suddenly blocked from receiving blood, leading to chest pain and changes in the heart's electrical activity. The study will compare the effects of a single injection of Zalunfiban with a placebo, which is an inactive substance, to understand its safety and effectiveness.

The purpose of the study is to assess the outcomes of patients 30 days after receiving the treatment. Participants will receive a single injection of Zalunfiban or a placebo before they reach the hospital. The study will monitor the patients for any major health events, such as death, stroke, or another heart attack, as well as any bleeding incidents, which are important safety concerns. The study aims to provide insights into how Zalunfiban might help improve the condition of patients with STEMI when administered early.

Throughout the study, patients will be observed for any side effects or reactions at the injection site. The trial will also track the patients' recovery and any additional treatments they might need. This research is important for understanding how Zalunfiban can be used to potentially improve outcomes for people experiencing a heart attack, offering new possibilities for treatment in emergency situations.

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, you will be informed about the trial's purpose and procedures. You will be asked to provide informed consent, which means you agree to participate after understanding the details of the study.
Step 2
Initial assessment
An initial assessment will be conducted to confirm your eligibility. This includes checking your medical history, current health status, and specific criteria related to your heart condition.
Step 3
Medication administration
You will receive a single subcutaneous injection of either zalunfiban or a placebo. This means the medication or placebo will be injected under your skin. The purpose is to evaluate the effects of the medication on your heart condition.
Step 4
Monitoring and follow-up
After the injection, your health will be monitored closely. This includes regular checks on your heart condition and any potential side effects. Monitoring will continue for up to 30 days to assess the treatment's impact.
You will be asked to report any symptoms or changes in your health during this period.
Step 5
Final assessment
At the end of the 30-day period, a final assessment will be conducted. This will involve evaluating your overall health and the effects of the treatment on your heart condition.
The results will help determine the safety and effectiveness of the medication.

Who can join the trial?

6 criteria

Planned transport to a participating clinical site.
Males aged 18 years or older.
Females who are post-menopausal or surgically sterile, aged 50 years or older.
Weight between 52 and 130 kg (115 and 287 lb).
Subjects with documented presumed STEMI (a type of heart attack), presenting with persistent chest pain lasting more than 10 minutes and new ST-segment elevation of 2 mm or more in two adjacent ECG leads. The total duration of symptoms to diagnostic ECG should be a maximum of 4 hours.
Enrollment by a process that includes verbal or written informed consent, which means the subject agrees to participate after understanding the study. This consent can be given by the subject or a legally authorized representative.

Who cannot join the trial?

4 criteria

Patients who have had a recent heart attack known as **STEMI** (ST-Elevation Myocardial Infarction) with specific changes in their heart's electrical activity.
Patients who have ongoing chest pain lasting more than 10 minutes.
Patients who have new changes in their heart's electrical activity, specifically a rise of 2 mm or more in two adjacent leads on an **ECG** (Electrocardiogram), which is a test that measures the electrical activity of the heart.
Patients whose total time from the start of symptoms to the diagnostic ECG is expected to be within 4 hours.

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Verified sites

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

Leids Universitair Medisch Centrum (LUMC)
Responsive
Leiden, The Netherlands
Semmelweis University
Responsive
Budapest, Hungary
Universitair Medisch Centrum Utrecht
Responsive
Utrecht, The Netherlands

Trial locations

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Investigated drugs

Zalunfiban is a medication being tested in this clinical trial to see if it can help people who are having a type of heart attack called ST-elevation myocardial infarction, or STEMI. This medication is given as a single injection under the skin before the patient reaches the hospital. The goal is to see if it can improve the patient's condition 30 days after the heart attack. The study also looks at whether the medication causes any serious bleeding problems, which is an important safety concern. By participating in this trial, researchers hope to find out if zalunfiban can be a safe and effective treatment for people experiencing this kind of heart attack.

Zalunfiban

What is already known about the treatment

Zalunfiban – Zalunfiban is administered as a single injection under the skin, known as a subcutaneous injection. It is currently being studied in clinical trials to determine its safety and effectiveness for people experiencing a specific type of heart attack called ST-elevation myocardial infarction (STEMI). The main purpose of zalunfiban is to help improve heart health outcomes by reducing the risk of further heart damage during a heart attack. It works by blocking certain proteins in the blood that can cause blood clots, which helps to keep blood flowing smoothly to the heart. Zalunfiban is classified as an antiplatelet medication, which means it helps prevent blood cells called platelets from sticking together and forming clots.

Investigated diseases

ST-Elevation Myocardial Infarction (STEMI) – This condition occurs when a coronary artery is completely blocked, leading to a significant portion of the heart muscle being deprived of oxygen. It is characterized by persistent chest pain lasting more than 10 minutes and noticeable ST-segment elevation in at least two adjacent leads on an electrocardiogram (ECG). The blockage is usually caused by a blood clot that forms on a ruptured plaque in the artery. As the heart muscle is deprived of oxygen, it begins to suffer damage, which can worsen over time if the blockage is not resolved. The progression of the disease can lead to complications such as heart failure or arrhythmias. Immediate medical intervention is crucial to restore blood flow and minimize heart muscle damage.