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Rituximab in Patients With ST-elevation Myocardial Infarction

NCT05211401 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 372

Last updated 2026-04-22

No results posted yet for this study

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.

Conditions

  • ST Elevated Myocardial Infarction

Interventions

DRUG

Active arm 1000 mg

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

DRUG

Placebo arm

Placebo arm: 1 bag of 500 ml of NaCl 0.9%

Sponsors & Collaborators

  • Institut National de la Santé Et de la Recherche Médicale, France

    collaborator OTHER_GOV

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Gabriel STEG · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-01
Primary Completion
2027-11-30
Completion
2028-05-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05211401 on ClinicalTrials.gov