Rituximab in Patients With ST-elevation Myocardial Infarction (RITA-MI2)

  • STATUS
    Recruiting
  • End date
    Dec 17, 2026
  • participants needed
    558
  • sponsor
    Assistance Publique - Hôpitaux de Paris
Updated on 17 June 2022
angiography
stemi
ischemia

Summary

The main objective is to compare the effect of a single injection of two doses of rituximab versus placebo on 6 months left ventricular systolic function, using CMR, in patients who have had an acute anterior STEMI.

The primary endpoint is the left ventricular ejection fraction (LVEF) by CMR at 6 months.

Description

RITA-MI 2 is an european phase IIb, multi-center, randomized, parallel, double-blind, placebo-controlled, clinical trial to assess the impact of B cell depletion with the CD20 mAb rituximab (200mg, and 1000mg MabThera®) on left ventricular dysfunction and cardiac remodelling after acute MI.

Sample size :

558 patients, 1:1:1 ratio

Assessement

Patients will be recruited immediately after admission for MI. The aim is to start the infusion of IMP within 3 hours of PPCI (defined as first balloon inflation).

Eligible patients will be offered to enter the study. If they accept, the investigator will collect informed written consent from the patient or from a person of trust/next of kin if the patient is unable to consent.

Once the inclusion is confirmed, a specific study blood sample will be taken for later assessment of cytokines and biomarkers related to immune responses, inflammation and cardiac remodelling. It will also be done at discharge and at 6 months.

According to usual practice the following blood exams will be done: Kidney function parameters (including serum creatinine, BUN, electrolytes, calcium and eGFR). It will also be done at day 5 (+ 2 days) and at 6 months.

NT-pro-BNP will be performed at admission and at 6 months. Blood leukocytes, platelets and hematologic/haemostatic will also be measured at admission and at 6 months.

The randomization will be performed and the pharmacy will extemporaneously prepare (aseptically) 2 infusion bags per patient (cf. treatments below).

During the infusion, the patient will be carefully monitored with continuous cardiac

telemetry
  • 12 lead ECG with QTc measurement will be performed pre-dosing and post-dosing at admission, discharge and at 6 months.
  • Kidney functions. The patients will be carefully monitored by their treating physicians, as done in usual care, with a special attention to the occurrence of any adverse event related to treatment.

CMR will be done at 5 days (+ 2 days) to assess the left ventricular (LV) function, the infarct size and microvascular obstruction and at 6 months.

Study staff at the clinical sites will contact each patient at 30 days, 3 months and 12 months following randomization, by phone or during a hospital visit.

The patient participation will last after the 12-month visit.

Details
Condition ST Elevated Myocardial Infarction
Treatment Placebo Arm, Active arm 200 mg, Active arm 1000 mg
Clinical Study IdentifierNCT05211401
SponsorAssistance Publique - Hôpitaux de Paris
Last Modified on17 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Inclusion Criteria
Age 18-75 (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
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 6 hours before admission
Plan to provide primary percutaneous angioplasty (PPCI) for the patient within 2 hours of ECG diagnosis
Ability to start infusion of rituximab within 3 hours of PPCI
Written informed consent

Exclusion Criteria

History of previous MI
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 MabThera® (rituximab) or to proteins of murine origin, or to any of the other excipients
Any contraindications to any of the Mabthera® 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 COVID-19 vaccination (with 2 doses of COVID-19 vaccination or patient
infected with COVID-19 and whom received one dose of COVID-19 vaccination)
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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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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