Rituximab in Patients With ST-elevation Myocardial Infarction

Korábbi kezelés

• 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;
• Any contraindications to any of the rituximab premedication drugs;
• 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);
• Previous history of progressive multifocal leukoencephalopathy;
• Inclusion in other interventional drug study within the previous 3 months;

Más betegség

• Presentation with cardiac arrest;
• 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 hepatitis B, HIV or tuberculosis;
• Severe, progressive infections documented;
• Active COVID-19 infection or COVID-19 infection within 3 months;
• Presence, or history in ≤ five years, of an ongoing cancer, (except in situ cancer of the cervix or basal cell carcinoma);
• Known hypersensitivity to the active substance of rituximab or to proteins of murine origin, or to any of the other excipients;
• Contraindications to injectable Polaramine:
  • Risk of closed-angle glaucoma, Risk of urinary retention linked to urethro-prostatic disorders;
• 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;

Laborértékek

• History of previous MI without documented preserved left ventricular ejection fraction (LVEF >50%) prior to the current admission will be an exclusion criterion;
• History of severe chronic renal failure (define as stage 4 (GFR = 15-29 mL/min) or worse);

Egyéb

• Cardiogenic shock (defined as systolic blood pressure <90 mmHg for >30minutes, or necessitating vasopressors to achieve a blood pressure ≥90 mmHg);
• Patient positive for point of care bedside test of Ag HBs;
• Patient with documented severe immune deficiency;
• QTcF> 450 msecs in males, > 470msecs in females;
• Inability to comply with study procedures;
• Patients under guardianship or curatorship.

• 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.