ST Elevated Myocardial InfarctionPhase 2RITA-MI2NCT05211401
Rituximab in Patients With ST-elevation Myocardial Infarction
A Phase 2 study testing Active arm 1000 mg in people with ST Elevated Myocardial Infarction, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ST Elevated Myocardial Infarction
- What is being tested?
- Active arm 1000 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 372 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2022to May 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 or a large inferior MI with evidence of low-ejection fraction (LVEF<45%);
- 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
Show all 9Show fewer
- Plan to provide primary percutaneous angioplasty (PPCI) for the patient within 2 hours of ECG diagnosis; confirmed before enrollment;
- Ability to start infusion of rituximab within 3 hours of PPCI ; confirmed before enrollment;
- Written informed consent.
Who cannot join
- History of previous MI without documented preserved left ventricular ejection fraction (LVEF >50%) prior to the current admission will be an exclusion criterion;
- 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);
Show all 32Show fewer
- 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) in their eye, or who have an aneurysm clip in their brain
- Patients who have had metallic devices placed in their back
- Known hypersensitivity to imaging products (gadoteric acid, meglumin or any drug containing gadolinium)
- Known hepatic failure;
- Previous history of progressive multifocal leukoencephalopathy;
- Inclusion in other interventional drug study within the previous 3 months;
- Inability to comply with study procedures;
- Patients under guardianship or curatorship.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Cardiology department, Hôpital Bichat, AP-HP
Paris, 75018
Philippe Gabriel STEG, 01 40 25 86 68, gabriel.steg@aphp.fr
Ziad MALLAT, 01 53 98 80 06, ziad.mallat@inserm.fr
About this study
Official title: Rituximab in Patients With ST-elevation Myocardial Infarction: A Phase 2 Placebo-controlled Randomized Clinical Trial: RITA-MI 2
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.
Read the detailed description
RITA-MI 2 is an european phase IIb, multi-center, randomized, parallel, double-blind, placebo-controlled, clinical trial to assess the impact of B cell depletion with the CD20 mAb rituximab (1000mg) on left ventricular dysfunction and cardiac remodelling after acute MI.
Sample size :
372 patients, 1:1 ratio
Assessement:
Patients will be recruited immediately after admission for MI. The aim is to start the infusion of IMP within 3 hours of PPCI (defined as first balloon inflation).
Eligible patients will be offered to enter the study. In France, Spain and Czech Republic: If they accept, the investigator will collect informed written consent from the patient or from a person of trust/next of kin if the patient is unable to consent. While In Germany, UK and Netherlands, only the patient will be informed and will be able to give consent and no next-of-kin will be informed and have the possibility to give consent.
Once the inclusion is confirmed, a specific study blood sample will be taken for later assessment of cytokines and biomarkers related to immune responses, inflammation and cardiac remodelling. It will also be done at discharge and at 6 months.
According to usual practice the following blood exams will be done: Kidney function parameters (including serum creatinine, BUN, electrolytes, calcium and eGFR). It will also be done at day 5 (+ 2 days) and at 6 months.
NT-pro-BNP will be performed at admission and at 6 months. Blood leukocytes, platelets and hematologic/haemostatic parameters will also be measured at admission and at 6 months.
The randomization will be performed and the pharmacy will extemporaneously prepare (aseptically) 2 infusion bags per patient (cf. treatments below).
During the infusion, the patient will be carefully monitored with continuous cardiac telemetry:
- 12 lead ECG with QTc measurement will be performed pre-dosing and post-dosing at admission, discharge and at 6 months.
- Kidney functions. The patients will be carefully monitored by their treating physicians, as done in usual care, with a special attention to the occurrence of any adverse event related to treatment.
CMR will be done at 5 days (+ 2 days) to assess the left ventricular (LV) function, the infarct size and microvascular obstruction and at 6 months.
Study staff at the clinical sites will contact each patient at 30 days, 3 months and 12 months following randomization, by phone or during a hospital visit.
The patient participation will last after the 12-month visit.
- Conditions
- ST Elevated Myocardial Infarction
- Being tested
- Active arm 1000 mg, Placebo arm
- Keywords
- Acute Myocardial Infarction, Anterior STEMI, Rituximab, Left ventricular systolic function, CMR, Cardiac remodelling
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active arm 1000 mgDrug
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
Placebo armDrug
Placebo arm: 1 bag of 500 ml of NaCl 0.9%
| Study group | Role | What they receive |
|---|---|---|
| Active arm 1000 mg | Experimental | 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. Receives: Drug: Active arm 1000 mg |
| Placebo arm | Placebo comparator | 1 bag of 500 ml of NaCl 0.9% Receives: Drug: Placebo arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (6)
Infarct size by CMR
To compare the effects of rituximab versus placebo on infarct size by CMR at day 5 (+/-2) and at 6 months.
Measured: At day 5 (+/-2) and at 6 months
Oedema extension by CMR
To compare the effects of rituximab versus placebo on oedema extension by CMR at day 5 (+/-2) .
Measured: At day 5 (+/-2)
T2 relaxation time at ischemic region by CMR
To compare the effects of rituximab versus placebo on T2 relaxation time at ischemic region by CMR (using T2 mapping) at day 5 (+/-2).
Measured: At day 5 (+/-2)
Microvascular obstruction by CMR
To compare the effects of rituximab versus placebo on microvascular obstruction by CMR (hypointense areas within LGE) at day 5 (+2/-) .
Measured: At day 5 (+/-2)
NT-pro-BNP
To compare the effects of rituximab versus placebo on NT-pro-BNP at 6 months.
Measured: At 6 months
Adverse event related to treatment
To compare the effects of rituximab versus placebo on any adverse event related to treatment .
Measured: Until 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study start1 Jun 2022
- Primary completionNov 2027 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ST Elevated Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 372 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gabriel STEG, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05211401
- Sponsor's protocol ID
- APHP210015
- Other IDs
- 2021-003340-24, 2022-501893-21-00
- Acronym
- RITA-MI2
- Status last verified
- Aug 2026
- First submitted
- 14 Jan 2022
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 40986007
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rituximab in Patients With ST-elevation Myocardial Infarction: A Phase 2 Placebo-controlled Randomized Clinical Trial: RITA-MI 2
- ClinicalTrials.gov ID
- NCT05211401
- Acronym / sponsor ID
- RITA-MI2 / APHP210015
- Conditions
- ST Elevated Myocardial Infarction
- Keywords
- Acute Myocardial Infarction, Anterior STEMI, Rituximab, Left ventricular systolic function, CMR, Cardiac remodelling
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 372 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 27 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
RITA-MI 2 is an european phase IIb, multi-center, randomized, parallel, double-blind, placebo-controlled, clinical trial to assess the impact of B cell depletion with the CD20 mAb rituximab (1000mg) on left ventricular dysfunction and cardiac remodelling after acute MI.
Sample size :
372 patients, 1:1 ratio
Assessement:
Patients will be recruited immediately after admission for MI. The aim is to start the infusion of IMP within 3 hours of PPCI (defined as first balloon inflation).
Eligible patients will be offered to enter the study. In France, Spain and Czech Republic: If they accept, the investigator will collect informed written consent from the patient or from a person of trust/next of kin if the patient is unable to consent. While In Germany, UK and Netherlands, only the patient will be informed and will be able to give consent and no next-of-kin will be informed and have the possibility to give consent.
Once the inclusion is confirmed, a specific study blood sample will be taken for later assessment of cytokines and biomarkers related to immune responses, inflammation and cardiac remodelling. It will also be done at discharge and at 6 months.
According to usual practice the following blood exams will be done: Kidney function parameters (including serum creatinine, BUN, electrolytes, calcium and eGFR). It will also be done at day 5 (+ 2 days) and at 6 months.
NT-pro-BNP will be performed at admission and at 6 months. Blood leukocytes, platelets and hematologic/haemostatic parameters will also be measured at admission and at 6 months.
The randomization will be performed and the pharmacy will extemporaneously prepare (aseptically) 2 infusion bags per patient (cf. treatments below).
During the infusion, the patient will be carefully monitored with continuous cardiac telemetry:
- 12 lead ECG with QTc measurement will be performed pre-dosing and post-dosing at admission, discharge and at 6 months.
- Kidney functions. The patients will be carefully monitored by their treating physicians, as done in usual care, with a special attention to the occurrence of any adverse event related to treatment.
CMR will be done at 5 days (+ 2 days) to assess the left ventricular (LV) function, the infarct size and microvascular obstruction and at 6 months.
Study staff at the clinical sites will contact each patient at 30 days, 3 months and 12 months following randomization, by phone or during a hospital visit.
The patient participation will last after the 12-month visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active arm 1000 mg | Experimental | Drug: Active arm 1000 mgActive 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 comparator | Drug: Placebo arm1 bag of 500 ml of NaCl 0.9% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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 or a large inferior MI with evidence of low-ejection fraction (LVEF<45%);
- 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
Key exclusion criteria (32 listed)
- History of previous MI without documented preserved left ventricular ejection fraction (LVEF >50%) prior to the current admission will be an exclusion criterion;
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active arm 1000 mgActive 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 | Drug | Active arm 1000 mg |
| Placebo armPlacebo arm: 1 bag of 500 ml of NaCl 0.9% | Drug | Placebo arm |
Primary outcome
Left ventricular ejection fraction (LVEF) by CMR at 6 months.
Time frame: 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 secondary outcomes
Infarct size by CMR
Time frame: At day 5 (+/-2) and at 6 months
Oedema extension by CMR
Time frame: At day 5 (+/-2)
T2 relaxation time at ischemic region by CMR
Time frame: At day 5 (+/-2)
Microvascular obstruction by CMR
Time frame: At day 5 (+/-2)
NT-pro-BNP
Time frame: At 6 months
Adverse event related to treatment
Time frame: Until 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Derived from this study: PubMed 40986007Yerly 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.
- Individual participant dataSharing planned: Undecided
Related trials for ST Elevated Myocardial Infarction
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
RecruitingPhase 2
Prevention of Reperfusion Injury Outcomes Through Effective Cardioprotection Targeting Myocardial Infarction
Myocardial Infarction, Reperfusion Injury
Not yet recruitingObservational study
Incremental Prognostic Utility of CBC-derived Inflammatory Indices After Incomplete Coronary Revascularization: Association With 12-months Cardiovascular Outcomes
STEMI, High Risk NSTEMI
RecruitingObservational study
SuperSaturated Oxygen Comprehensive Observational Registry
STEMI - ST Elevation Myocardial Infarction, AMI
RecruitingPhase 4
Efficacy and Safety of a Half-dose Bolus of r-SAK Prior to Primary PCI in ST-elevation Myocardial Infarction
ST Elevation Myocardial Infarction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gabriel STEG principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Active arm 1000 mg in people with ST Elevated Myocardial Infarction, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gabriel STEG (01 40 25 86 68, gabriel.steg@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left ventricular ejection fraction (LVEF) by CMR at 6 months. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05211401, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.