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Study on Rituximab for Patients with Acute Myocardial Infarction

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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 the medication rituximab in patients who have experienced a type of heart attack known as ST-elevation myocardial infarction (STEMI). STEMI is a serious condition where a major artery in the heart is blocked, leading to significant heart muscle damage. The purpose of the study is to compare the effects of a single injection of rituximab with a placebo on heart function six months after the heart attack.

Participants in the study will receive either rituximab or a placebo through an intravenous infusion, which means the medication is delivered directly into the bloodstream through a vein. The study will also involve the use of other medications such as paracetamol, clemastine, chlorphenamine maleate, methylprednisolone, and sodium chloride as part of the treatment process. These medications are commonly used to manage symptoms and support the treatment process. The study will monitor the heart's pumping ability, known as the left ventricular ejection fraction, using a special imaging technique called CMR (Cardiac Magnetic Resonance) six months after the heart attack.

Throughout the study, additional assessments will be conducted to evaluate the size of the heart attack, the presence of swelling in the heart tissue, and any potential side effects related to the treatment. These assessments will help researchers understand the impact of rituximab on heart recovery after a STEMI. The study aims to provide valuable insights into improving treatment options for patients who have suffered from this type of heart attack.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the trial

    Upon joining the trial, you will be required to provide written informed consent. This confirms your understanding and agreement to participate in the study.

  2. Step 2

    Initial treatment

    You will receive a single injection of rituximab or a placebo. This will be administered through an intravenous infusion, which means the medication will be delivered directly into your bloodstream through a vein.

    The infusion will be started within 3 hours after a procedure called primary percutaneous coronary intervention (PPCI), which is a treatment for your heart condition.

  3. Step 3

    Monitoring and follow-up

    Your heart function will be monitored using a test called cardiac magnetic resonance imaging (CMR) at 6 months. This test will help assess the effect of the treatment on your heart's ability to pump blood.

    Additional assessments will be conducted between day 3 and day 7 after the initial treatment. These assessments will include measuring the size of the heart attack, the extent of swelling in the heart tissue, and other related factors.

  4. Step 4

    End of trial assessments

    At the end of the trial, your heart function will be evaluated again using CMR to determine the long-term effects of the treatment.

    Any side effects or adverse events related to the treatment will be recorded and assessed throughout the trial period.

Who can join the trial?

8 criteria

  • Must be over 18 years old. There is no upper age limit.
  • Women must be either postmenopausal (not having periods for more than 2 years and showing signs like hot flashes) or have had a hysterectomy (surgery to remove the uterus) and/or bilateral oophorectomy (surgery to remove both ovaries).
  • Must have clinical evidence of an anterior ST-elevation myocardial infarction (STEMI), which means having symptoms of a heart attack and an electrocardiogram (ECG) showing specific changes in heart activity.
  • Must have a complete blockage of a specific heart artery (left anterior descending coronary artery) as seen in an urgent heart imaging test.
  • Symptoms must have started within 48 hours before the planned heart procedure called primary percutaneous coronary intervention (PPCI), which is a treatment to open blocked heart arteries.
  • The plan must be to perform the PPCI within 2 hours of the ECG diagnosis.
  • Must be able to start the infusion of the study medication, rituximab, within 3 hours after the PPCI.
  • Must provide written informed consent, which means agreeing to participate in the study after understanding all the details.

Who cannot join the trial?

4 criteria

  • Patients who have not had an acute myocardial infarction (a heart attack).
  • Patients who have not experienced an ST segment elevation myocardial infarction (STEMI) (a specific type of heart attack).
  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

Rituximab is a medication used in this clinical trial to help improve heart function in patients who have experienced a specific type of heart attack known as ST-elevation myocardial infarction (STEMI). It is given as a single injection and works by targeting certain cells in the immune system. The goal of using rituximab in this trial is to see if it can help the heart pump blood more effectively after a heart attack.

What is already known about the treatment

Rituximab – Rituximab is administered as a single injection and is currently being studied in a clinical trial for its effects on heart function after a heart attack, specifically in patients with ST-elevation myocardial infarction (STEMI). It is not yet widely used for this purpose in medical practice, as it is still under investigation. The main therapeutic indication being explored is its potential to improve heart function following a severe heart attack. Rituximab works by targeting specific cells in the immune system, which may help reduce inflammation and damage in the heart. It is classified as a monoclonal antibody, a type of medication that binds to specific proteins in the body.

Investigated diseases

  • Acute myocardial infarction

    This condition 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. It is commonly known as a heart attack. 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 artery. The affected heart muscle becomes deprived of oxygen and nutrients, leading to tissue damage. Over time, this can affect the heart's ability to pump blood effectively.

  • ST segment elevation myocardial infarction

    This is a severe form of heart attack where there is a long interruption to the blood supply, affecting a large area of the heart muscle. It is characterized by a specific pattern on an electrocardiogram (ECG) known as ST segment elevation. This type of myocardial infarction indicates that a significant portion of the heart muscle is at risk of damage. The blockage in the coronary artery is often complete, leading to more extensive heart muscle damage. The heart's pumping ability can be significantly impaired, and the risk of complications is higher compared to other types of heart attacks. Immediate medical attention is crucial to restore blood flow and minimize heart damage.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-501893-21-00Estimated enrolment416 patientsSponsorAssistance Publique Hopitaux De Paris

sourced from the EU Clinical Trials Register and site verification

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