Informations générales (source: ClinicalTrials.gov)

NCT05211401 En recrutement IDF
Rituximab in Patients With ST-elevation Myocardial Infarction: A Phase 2 Placebo-controlled Randomized Clinical Trial: RITA-MI 2
Interventional
  • Infarctus du myocarde avec sus-décalage du segment ST
  • Infarctus
  • Infarctus du myocarde
Phase 2
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
juin 2022
avril 2027
15 septembre 2025
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. Following the sponsor's decision to stop enrolment in the 200 mg arm, the primary objective of the study is to evaluate the efficacy of a single 1000 mg dose of rituximab versus placebo. The primary endpoint is the left ventricular ejection fraction (LVEF) by CMR at 6 months.
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Etablissements

Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données
CENTRE HOSPITALIER SUD FRANCILIEN STEG Philippe En recrutement IDF 25/10/2025 09:49:15  Contacter
GHI LE RAINCY MONTFERMEIL STEG Philippe En recrutement IDF 25/10/2025 09:49:15  Contacter
AP-HP Assistance publique - Hôpitaux de Paris En recrutement IDF 25/10/2025 09:49:16  Contacter
AP-HP - Hôpital Bichat
AP-HP - Hôpital Europeen Georges Pompidou
AP-HP - Hôpital Henri Mondor-Albert Chenevier

Critères

Tous
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;

- 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;

- 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 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.