RecruitingPhase 2NCT05211401

Rituximab in Patients With ST-elevation Myocardial Infarction

Rituximab in Patients With ST-elevation Myocardial Infarction: A Phase 2 Placebo-controlled Randomized Clinical Trial: RITA-MI 2

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

372 participants

Start Date

Jun 1, 2022

Study Type

INTERVENTIONAL

Conditions

ST Elevated Myocardial Infarction

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether rituximab (a drug that reduces immune cell activity) given shortly after an emergency heart stent procedure can reduce heart muscle damage caused by a heart attack. It targets the inflammatory immune response that causes additional injury after the blood flow is restored. You may be eligible if... - You are 18 years or older - You are experiencing a front-wall (anterior) STEMI heart attack - The main artery causing the heart attack is completely blocked - Your symptoms started within 48 hours - You are being treated urgently with a stent (PPCI) - You have an adequate platelet count and white blood cell count You may NOT be eligible if... - You have had a previous heart attack - You are in cardiac arrest or cardiogenic shock - You have hepatitis B, HIV, or active tuberculosis - You have active cancer or a cancer history within the past 5 years - You have had an organ transplant - You are currently on immunosuppressant therapy - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGActive 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

DRUGPlacebo arm

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

Locations(1)

Cardiology department, Hôpital Bichat, AP-HP

Paris, France

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NCT05211401

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