Rituximab in Patients With ST-elevation Myocardial Infarction (NCT05211401) | Clinical Trial Compass
RecruitingPhase 2
Rituximab in Patients With ST-elevation Myocardial Infarction
France372 participantsStarted 2022-06-01
Plain-language 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. 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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:
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 pacin…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing rituximab, a drug typically used for blood cancers and autoimmune conditions, in people who've had a heart attack — can you explain why targeting the immune system this way might help my heart recover, and what's known about its safety in heart attack patients specifically?
2Since this is a Phase 2 trial, what does that mean for what researchers already know versus what they're still trying to figure out about whether rituximab is safe and effective after a STEMI?
3The main thing they're measuring is my heart's pumping function — called ejection fraction — at 6 months using an MRI-type scan called CMR; how does that compare to how you'd normally monitor my heart recovery, and would joining this trial change the standard care I'd otherwise receive?
4Are there particular characteristics of my heart attack or my overall health that would make this trial a poor fit for me, or that would make standard treatment a safer first step?
5What would the commitment look like for me practically — how many visits, how much time, and are there any monitoring requirements tied to receiving rituximab that I should plan around?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Left ventricular ejection fraction (LVEF) by CMR at 6 months.