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Study on the Safety and Effectiveness of ApTOLL for Patients with ST Elevation Myocardial Infarction (STEMI)

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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 a heart condition known as ST Elevation Myocardial Infarction (STEMI), which is a type of heart attack. The trial is investigating a treatment called ApTOLL, which is a new medication being tested for its safety and effectiveness in patients experiencing this condition. ApTOLL is administered as a concentrate for injection or infusion, and it contains an active substance called APTAMER-4FT, which is derived from nucleic acids. The study also involves a comparison with a placebo to evaluate the effects of ApTOLL.

The purpose of the study is to assess the safety of ApTOLL at two different doses in patients who are candidates for emergency procedures to open blocked heart arteries, known as angioplasty, without having received clot-dissolving medications. Participants in the study will receive ApTOLL through an intravenous bolus, which means it is given directly into a vein in a single, quick dose. The study will monitor participants for any adverse effects, such as severe low blood pressure, irregular heart rhythms, or heart failure, over a period of 90 days after receiving the treatment.

Throughout the study, the effects of ApTOLL on the heart will be measured using imaging techniques like MRI and echocardiography. These tests will help determine changes in the size of the heart attack area and the heart's ability to pump blood. Additionally, the study will measure levels of certain proteins in the blood that indicate inflammation and heart damage. These measurements will be taken at various times after the treatment to understand how ApTOLL affects the heart and the body's response to the heart attack.

The research process

The trial runs in 6 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, informed consent is obtained from the participant or an acceptable surrogate, such as a next of kin or legal representative.
Eligibility is confirmed, including age requirements and, for women of childbearing potential, a negative pregnancy test and agreement to use effective birth control methods for 7 days after receiving the dose.
Step 2
Initial treatment
Participants receive an intravenous bolus of either ApTOLL or a placebo. The dosage of ApTOLL is either 0.2 mg/kg or 0.4 mg/kg.
This treatment is administered to patients who are candidates for emergency angioplasty due to a specific type of heart attack known as ST Elevation Myocardial Infarct (STEMI).
Step 3
Monitoring and safety evaluation
The safety of ApTOLL is evaluated by monitoring for any adverse events, such as severe low blood pressure, irregular heart rhythms, or heart failure, during the first 72 hours after administration or until discharge, if earlier.
All-cause mortality is also tracked for 90 days following the administration of ApTOLL.
Step 4
Early assessment of heart damage
Five days after randomization, a magnetic resonance imaging (MRI) scan is performed to measure the early impact of ApTOLL on heart damage. This includes assessing the size and mass of the heart damage and the heart's pumping efficiency.
Step 5
Follow-up assessments
At 72 hours and again at 90 days after randomization, an echocardiogram is conducted to evaluate heart function, including heart volume, pumping efficiency, and other cardiac parameters.
Blood tests are performed at baseline, 24, 48, and 72 hours after randomization to measure levels of specific proteins and markers related to inflammation and heart damage.
Step 6
Long-term evaluation
At 90 days after randomization, a final MRI is conducted to assess any late changes in heart damage, including the size and mass of the damage and the heart's pumping efficiency.

Who can join the trial?

5 criteria

The patient or their legal representative must give permission to participate in the study.
The patient must be a man or woman who is at least 18 years old.
If the patient is a woman who can have children, she must confirm her menstrual period and have a negative pregnancy test. She must also use very effective birth control methods for 7 days after receiving the dose. If the patient is a man with a partner who can have children, they must also use very effective birth control methods for 7 days after receiving the dose.
The patient must be admitted with a heart condition called **STEMI** (a type of heart attack) within 6 hours of the start of symptoms. They should not have received a treatment called thrombolytic therapy for this condition. **STEMI** is identified by specific changes in the heart's electrical activity, seen on an **ECG** (a test that records the heart's electrical signals).
The patient must be a suitable candidate for a procedure called **pPCI** (a type of emergency treatment for **STEMI**).

Who cannot join the trial?

2 criteria

Patients who have already received **thrombolytics**. Thrombolytics are medicines that help dissolve blood clots.
Patients who are not candidates for emergency **angioplasty**. Angioplasty is a procedure to open blocked blood vessels in the heart.

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Verified sites

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

Verified
Bellvitge University Hospital
L'hospitalet De Llobregat, Spain
Responsive
Complexo Hospitalario Universitario De Vigo
Vigo, Spain
Verified
Hospital Clinico San Carlos
Madrid, Spain

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Investigated drugs

ApTOLL is a medication being studied for its safety and effectiveness in patients who have experienced a type of heart attack known as ST Elevation Myocardial Infarction (STEMI). It is given through an intravenous injection to patients who are undergoing emergency procedures to open blocked heart arteries. The trial aims to determine how safe ApTOLL is for these patients and how well it works in helping their recovery.

Aptamer-4Ft

What is already known about the treatment

ApTOLL – ApTOLL is administered intravenously as a bolus injection, with doses of 0.2 mg/kg and 0.4 mg/kg being studied. It is currently in a Phase IIa clinical trial to evaluate its safety and effectiveness in patients experiencing ST Elevation Myocardial Infarction (STEMI). The main therapeutic indication for ApTOLL is to assist patients who are candidates for emergency angioplasty, particularly those who have not received thrombolytic therapy. At the molecular level, ApTOLL works by modulating the immune response, potentially reducing inflammation and tissue damage during a heart attack. It is classified pharmacologically as an immunomodulatory agent.

Investigated diseases

ST-Elevation Myocardial Infarction (STEMI) – This is a type of heart attack characterized by a significant elevation in the ST segment on an electrocardiogram, indicating a complete blockage of a coronary artery. It occurs when a blood clot forms on a ruptured plaque in a coronary artery, leading to a sudden reduction in blood flow to a part of the heart muscle. As the heart muscle is deprived of oxygen, it begins to suffer damage, which can worsen over time if the blockage is not quickly resolved. Symptoms often include chest pain, shortness of breath, and other signs of cardiac distress. The progression of the condition can lead to complications such as heart failure or arrhythmias if not promptly treated.