Study on Rituximab for Patients with Acute Myocardial Infarction

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What is this study about?

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.

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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Lille	Lille	France
Zuyderland Medisch Centrum Stichting	Geleen	The Netherlands
Hospital Universitario De Salamanca	Salamanca	Spain
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
CHU Grenoble Alpes	La Tronche	France

Other Sites

Site Name	City	Country
Hospices Civils De Lyon	Lyon	France
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Fakultni Nemocnice Kralovske Vinohrady	Prague	Czechia
Fakultni Nemocnice U Sv Anny V Brne	Brno-Stred	Czechia
Centre Hospitalier Saint Joseph Saint Luc	Lyon	France
Centre Hospitalier Universitaire Rouen	Rouen	France
Assistance Publique Hopitaux De Paris	Paris	France
Centre Hospitalier Universitaire De Toulouse	Toulouse	France
St. Antonius Ziekenhuis	Nieuwegein	The Netherlands
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)	Munich	Germany
Centre Hospitalier Universitaire De Nimes	Nimes	France
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Deutsches Herzzentrum Berlin	Berlin	Germany
Hospital Pasteur	Nice	France
Cqgrqv Hvlfjheljve Uzcyelsqkfebb Do Dgizv	Dijon	France
Azlyyhmtma Pghygmyc Hjkffdsv Dh Pvdjv	Paris	France
Cyikvg Hvikgzejlhs Rcwjtnij Divttqddixiowu	Angers	France
Htvodpw Hcpkm Mdobgh &fcraus 1 rar Gdycizi Evqvom	Creteil	France

Trial status

Country	Status	Recruitment Start
Czechia	Recruiting	01.06.2022
France	Recruiting	01.06.2022
Germany	Recruiting	01.06.2022
Spain	Recruiting	01.06.2022
The Netherlands	Not yet recruiting	01.06.2022

Trial locations

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.

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 ID:

2022-501893-21-00

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Rituximab for Patients with Acute Myocardial Infarction

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