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New treatment option for ST Elevated Myocardial Infarction
Official title Rituximab in Patients With ST-elevation Myocardial Infarction
ClinicalTrials.gov ID: NCT05211401
What this study is testing
What is Active arm 1000 mg?
Active arm 1000 mg is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for st elevated myocardial infarction.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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 evidence at presentation of anterior ST-elevation myocardial infarction (STEMI) defined as symptoms suggestive of acute myocardial ischemia...
- Complete occlusion (i.e. TIMI flow 0-1) of proximal or mid left anterior descending (LAD) coronary artery on urgent angiography interpreted as the...
- Onset of worse symptoms within 48 hours before primary PCI;
- Patients with neutrophils \>1.5 x 109/L at the moment of admission
You likely can't join if
- Exclusion Criteria :
- History of previous MI;
- Presentation with cardiac arrest;
- Cardiogenic shock (defined as systolic blood pressure \ 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;
See the full eligibility 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...
- 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...
- 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 \ 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)...
- Known hepatic failure;
- Previous history of progressive multifocal leukoencephalopathy;
- Inclusion in other treatment drug study within the previous 3 months;
- Inability to comply with study procedures;
- Patients under guardianship or curatorship.
The study team makes the final eligibility decision.
Where it's taking place
- Paris, France
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Paris, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.