Authorised Therapeutic exploratory (Phase II) Acute myocardial infarction

Rituximab in patients with ST-elevation myocardial infarction. A phase 2 placebo-controlled randomized clinical trial.

EU CTIS ID: 2022-501893-21-00

What this study is testing

The primary 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 or a large inferior MI.

Therapeutic exploratory (Phase II)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

1) 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) ;
2) 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%)
3) 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);
4) Onset of worse symptoms within 48 hours before primary PCI;
5) Patients with neutrophils >1.5 x 109/L at the moment of admission
6) Patients with platelet counts >75 x 109/L at the moment of admission

You likely can't join if

1) History of previous myocardial infarction without documented preserved left ventricular ejection fraction (LVEF >50%) prior to the current admission will be an exclusion criterion
25) Inability to comply with study procedures
26) Patients under guardianship or curatorship
10) Active COVID-19 infection or COVID-19 infection within 3 months
3) Cardiogenic shock (defined as systolic blood pressure <90 mmHg for >30minutes, or necessitating vasopressors to achieve a blood pressure ≥90 mmHg)
4) Cardiac electrical instability (defined as complete heart block needing temporary pacing or any tachyarrhythmia needing cardioversion)

See the full eligibility criteria

Who can join

1) 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) ;
2) 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%)
3) 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);
4) Onset of worse symptoms within 48 hours before primary PCI;
5) Patients with neutrophils >1.5 x 109/L at the moment of admission
6) Patients with platelet counts >75 x 109/L at the moment of admission
7) Plan to provide primary percutaneous angioplasty (PPCI) for the patient within 2 hours of ECG diagnosis confirmed before enrollment ;;
8) Ability to start infusion of rituximab within 3 hours of PPCI ;confirmed before enrollment ;
9) Written informed consent.

What rules you out

1) History of previous myocardial infarction without documented preserved left ventricular ejection fraction (LVEF >50%) prior to the current admission will be an exclusion criterion
25) Inability to comply with study procedures
26) Patients under guardianship or curatorship
10) Active COVID-19 infection or COVID-19 infection within 3 months
3) Cardiogenic shock (defined as systolic blood pressure <90 mmHg for >30minutes, or necessitating vasopressors to achieve a blood pressure ≥90 mmHg)
4) Cardiac electrical instability (defined as complete heart block needing temporary pacing or any tachyarrhythmia needing cardioversion)
6) History of severe chronic renal failure (defined as stage 4 (GFR = 15-29 mL/min) or worse)
7) History of hepatitis B, HIV or tuberculosis
8) Patient positive for point of care bedside test of Ag HBs
9) Severe, progressive infections documented
11) Patient with documented severe immune deficiency
18) Contraindications to injectable Polaramine: o Risk of closed-angle glaucoma, o Risk of urinary retention linked to urethro-prostatic disorders
12) Presence, or history in ≤ five years, of an ongoing cancer, (except in situ cancer of the cervix or basal cell carcinoma)
13) QTcF> 450 msecs in males, > 470msecs in females
14) Any oral or intravenous immunosuppressive treatment, immune modulatory monoclonal antibodies or immunodepleting therapy at any time (inhalers and topical creams with corticosteroids are permitted)
15) Previous history of major organ transplant including renal transplant
16) Known hypersensitivity to the active substance of rituximab or to proteins of murine origin, or to any of the other excipients
17) Any contraindications to any of the rituximab premedication drugs
5) Patients with Killip class III heart failure
19) 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)
2) Presentation with cardiac arrest
20) Absence of a complete COVID-19 vaccination scheme (including recovery from documented COVID infection) as approved at the time of enrolment in the country where the patient is recruited
21) Any obvious contraindications for MRI or conditions which will impede image acquisition for example: o Severe claustrophobia o Non-MRI compatible permanent pacemaker o Patients who have a metallic foreign body (metal silver) in their eye, or who have an aneurysm clip in their brain o Patients who have had metallic devices placed in their back o Known hypersensitivity to imaging products (gadoteric acid, meglumin or any drug containing gadolinium)
22) Known hepatic failure
23) Previous history of progressive multifocal leukoencephalopathy
24) Inclusion in other interventional drug study within the previous 3 months

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

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, 18-64 years, 65+ years. The study team makes the final eligibility decision.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.