Rituximab in Patients With ST-elevation Myocardial Infarction
RITA-MI2
3 other identifiers
interventional
372
1 country
1
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2022
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 14, 2022
CompletedFirst Posted
Study publicly available on registry
January 27, 2022
CompletedStudy Start
First participant enrolled
June 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2028
April 22, 2026
April 1, 2026
5.4 years
January 14, 2022
April 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Left ventricular ejection fraction (LVEF) by CMR at 6 months.
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.
6 months
Secondary Outcomes (6)
Infarct size by CMR
At day 5 (+/-2) and at 6 months
Oedema extension by CMR
At day 5 (+/-2)
T2 relaxation time at ischemic region by CMR
At day 5 (+/-2)
Microvascular obstruction by CMR
At day 5 (+/-2)
NT-pro-BNP
At 6 months
- +1 more secondary outcomes
Study Arms (2)
Active arm 1000 mg
EXPERIMENTALActive arm 1000 mg: 1 bag containing 1000 mg of rituximab\* in 500 ml of NaCl 0.9% \* Mabthera® and all registered biosimilars are likely to be used in this trial.
Placebo arm
PLACEBO COMPARATOR1 bag of 500 ml of NaCl 0.9%
Interventions
Active arm 1000 mg: 1 bag containing 1000 mg of rituximab\* in 500 ml of NaCl 0.9% \* Mabthera® and all registered biosimilars are likely to be used in this trial
Eligibility Criteria
You may qualify 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 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.
You may not qualify if:
- 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;
- +15 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cardiology department, Hôpital Bichat, AP-HP
Paris, 75018, France
Related Publications (1)
Yerly A, van der Vorst EPC, Schindewolf M, Kotelis D, Noels H, Doring Y. Chemokine-receptor-guided B-cell immunity in cardiovascular disease. Basic Res Cardiol. 2025 Dec;120(6):1075-1090. doi: 10.1007/s00395-025-01140-x. Epub 2025 Sep 23.
PMID: 40986007DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gabriel STEG
Assistance Publique - Hôpitaux de Paris
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 14, 2022
First Posted
January 27, 2022
Study Start
June 1, 2022
Primary Completion (Estimated)
November 1, 2027
Study Completion (Estimated)
May 1, 2028
Last Updated
April 22, 2026
Record last verified: 2026-04