Clinical Trials Logo

Clinical 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. The primary endpoint is the left ventricular ejection fraction (LVEF) by CMR at 6 months.


Clinical Trial 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 (200mg, and 1000mg MabThera®) on left ventricular dysfunction and cardiac remodelling after acute MI. Sample size : 558 patients, 1:1:1 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. 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. 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 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


Related Conditions & MeSH terms


NCT number NCT05211401
Study type Interventional
Source Assistance Publique - Hôpitaux de Paris
Contact Gabriel STEG
Phone 01 40 25 86 68
Email [email protected]
Status Not yet recruiting
Phase Phase 2
Start date February 2022
Completion date December 2026

See also
  Status Clinical Trial Phase
Completed NCT04057404 - Smartphone Twelve Lead Electrocardiogram Utility In ST Elevation Myocardial Infarction
Recruiting NCT04183140 - Comparison of Radial and Ulnar Artery Intervention in Patients With ST Elevated Myocardial Infarction N/A
Recruiting NCT04002739 - PRedictOrs, PHEnotypes and Timing of Obstructive Sleep Apnea in Acute Coronary Syndrome N/A
Completed NCT01663194 - Neutrophil/Lymphocyte (N/L) Ratio and Long Term Follow-up in ST-elevation Myocardial Infarction N/A
Recruiting NCT04887571 - the PrEsentation, Rationale and Impact of reperFUSION for Acute Coronary Syndromes in Cape Town and the Garden Route Health District - the PERFUSION Registry