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RECRUITING
NCT05211401
PHASE2

Rituximab in Patients With ST-elevation Myocardial Infarction

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

372

Start Date

2022-06-01

Completion Date

2027-04

Last Updated

2025-06-27

Healthy Volunteers

No

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%

Locations (1)

Cardiology department, Hôpital Bichat, AP-HP

Paris, France