Actively Recruiting
Rituximab in Patients With ST-elevation Myocardial Infarction
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2026-04-22
372
Participants Needed
1
Research Sites
308 weeks
Total Duration
On this page
Sponsors
A
Assistance Publique - Hôpitaux de Paris
Lead Sponsor
I
Institut National de la Santé Et de la Recherche Médicale, France
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Rituximab in Patients With ST-elevation Myocardial Infarction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older with no upper age limit (women must be postmenopausal or have had hysterectomy and/or bilateral oophorectomy)
- Clinical evidence of anterior ST-elevation myocardial infarction (STEMI) with symptoms suggestive of acute ischemia
- Electrocardiogram showing ST-segment elevation ≥2 mm in at least 2 contiguous leads in V1 to V4
- Complete occlusion (TIMI flow 0-1) of proximal or mid left anterior descending coronary artery on urgent angiography
- Onset of worsening symptoms within 48 hours before primary percutaneous coronary intervention (PPCI)
- Neutrophil count greater than 1.5 x 10^9/L at admission
- Platelet count greater than 75 x 10^9/L at admission
- Planned primary percutaneous angioplasty (PPCI) within 2 hours of ECG diagnosis
- Ability to start rituximab infusion within 3 hours of PPCI
- Written informed consent provided
You will not qualify if you...
- History of previous myocardial infarction
- Presentation with cardiac arrest
- Cardiogenic shock defined as systolic blood pressure less than 90 mmHg for more than 30 minutes or requiring vasopressors
- Cardiac electrical instability needing temporary pacing or cardioversion
- Killip class III heart failure
- Severe chronic renal failure (stage 4 or worse)
- History of hepatitis B, HIV, or tuberculosis
- Positive point of care test for hepatitis B surface antigen
- Severe, progressive infections
- Active COVID-19 infection or infection within the last 3 months
- Documented severe immune deficiency
- Cancer ongoing or within the past 5 years, except certain skin or cervical cancers
- QTcF >450 ms in males or >470 ms in females
- Use of systemic immunosuppressive or immune-depleting treatments
- Previous major organ transplant
- Known hypersensitivity to rituximab or its components
- Contraindications to rituximab premedications or injectable Polaramine
- Expected need for live attenuated vaccine during study
- Incomplete COVID-19 vaccination as approved in the recruitment country
- Contraindications to MRI or conditions preventing imaging
- Known hepatic failure
- History of progressive multifocal leukoencephalopathy
- Participation in another drug study within 3 months
- Inability to comply with study procedures
- Under guardianship or curatorship
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Cardiology department, Hôpital Bichat, AP-HP
Paris, France, 75018
Actively Recruiting
Research Team
G
Gabriel STEG
CONTACT
Z
Ziad MALLAT
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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