Status:
RECRUITING
Rituximab in Patients With ST-elevation Myocardial Infarction
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Institut National de la Santé Et de la Recherche Médicale, France
Conditions:
ST Elevated Myocardial Infarction
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ...
Detailed 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 (1000mg) o...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2027
Estimated Enrollment :
372 Patients enrolled
Trial Details
Trial ID
NCT05211401
Start Date
June 1 2022
End Date
April 1 2027
Last Update
June 27 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Cardiology department, Hôpital Bichat, AP-HP
Paris, France, 75018