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Could a single dose of rituximab help hearts heal after a massive attack?

NCT ID NCT05211401

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Aug 13, 2026 · Updated 3 times

Summary

This study tests whether a single dose of rituximab, a drug that calms the immune system, can help the heart pump better six months after a severe type of heart attack called an anterior STEMI. About 372 adults who have just had such an attack will receive either rituximab or a placebo. The main goal is to see if the drug improves the heart's pumping strength, measured by MRI.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
rituximab
What this could lead to
If it works, this could point toward a new treatment to help the heart recover better after a major heart attack.
What could go wrong
This is an early phase 2 trial, so results are uncertain. Rituximab is an immune-suppressing drug, which carries risks like increased infection. The benefit may be small or absent.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 372 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2022

Expected to finish

May 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age ≥ 18 years with no upper limit (women must be either postmenopausal defined as being amenorrhoeic for greater than 2 years with an appropriate clinical profile, e.g. age appropriate (\>55 years old), history of vasomotor symptoms) or having documented hysterectomy and/or bilateral oophorectomy) ; * \- Clinical evidence at presentation of anterior ST-elevation myocardial infarction (STEMI) defined as symptoms suggestive of acute myocardial ischemia, an electrocardiogram showing ST-segment elevation ≥2 mm in ≥2 contiguous leads in V1 to V4 or a large inferior MI with evidence of low-ejection fraction (LVEF\<45%); * Complete occlusion (i.e. TIMI flow 0-1) of proximal or mid left anterior descending (LAD) coronary artery on urgent angiography interpreted as the infarct-related artery (IRA); * Onset of worse symptoms within 48 hours before primary PCI; * Patients with neutrophils \>1.5 x 109/L at the moment of admission * Patients with platelet counts \>75 x 109 /L at the moment of admission * Plan to provide primary percutaneous angioplasty (PPCI) for the patient within 2 hours of ECG diagnosis; confirmed before enrollment; * Ability to start infusion of rituximab within 3 hours of PPCI ; confirmed before enrollment; * Written informed consent. Exclusion Criteria: Exclusion Criteria : * History of previous MI without documented preserved left ventricular ejection fraction (LVEF \>50%) prior to the current admission will be an exclusion criterion; * Presentation with cardiac arrest; * Cardiogenic shock (defined as systolic blood pressure \<90 mmHg for \>30minutes, or necessitating vasopressors to achieve a blood pressure ≥90 mmHg); * Cardiac electrical instability (defined as complete heart block needing temporary pacing or any tachyarrhythmia needing cardioversion); * Patients with Killip class III heart failure; * History of severe chronic renal failure (define as stage 4 (GFR = 15-29 mL/min) or worse); * History of hepatitis B, HIV or tuberculosis; * Patient positive for point of care bedside test of Ag HBs; * Severe, progressive infections documented; * Active COVID-19 infection or COVID-19 infection within 3 months; * Patient with documented severe immune deficiency; * Presence, or history in ≤ five years, of an ongoing cancer, (except in situ cancer of the cervix or basal cell carcinoma); * QTcF\> 450 msecs in males, \> 470msecs in females; * Any oral or intravenous immunosuppressive treatment, immune modulatory monoclonal antibodies or immunodepleting therapy at any time (inhalers and topical creams with corticosteroids are permitted); * Previous history of major organ transplant including renal transplant; * Known hypersensitivity to the active substance of rituximab or to proteins of murine origin, or to any of the other excipients; * Any contraindications to any of the rituximab premedication drugs; * Contraindications to injectable Polaramine: Risk of closed-angle glaucoma, Risk of urinary retention linked to urethro-prostatic disorders; * Expected need for vaccination with a live attenuated vaccine during the study, including incomplete vaccination courses (in case, life, attenuated vaccine must be administered at least 30 days before inclusion in study); * Absence of a complete COVID-19 vaccination scheme (including recovery from documented COVID infection) as approved at the time of enrollment in the country where the patient is recruited; * Any obvious contraindications for MRI or conditions which will impede image acquisition for example: Severe claustrophobia Non-MRI compatible permanent pacemaker Patients who have a metallic foreign body (metal silver) in their eye, or who have an aneurysm clip in their brain Patients who have had metallic devices placed in their back Known hypersensitivity to imaging products (gadoteric acid, meglumin or any drug containing gadolinium) * Known hepatic failure; * Previous history of progressive multifocal leukoencephalopathy; * Inclusion in other interventional drug study within the previous 3 months; * Inability to comply with study procedures; * Patients under guardianship or curatorship.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Cardiology department, Hôpital Bichat, AP-HP

    RECRUITING

    Paris, 75018, France

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