drugset / Trial / NCT05211401
Rituximab in Patients With ST-elevation Myocardial Infarction
Phase 2
Recruiting
372 enrolled
Assistance Publique - Hôpitaux de Paris
Institut National de la Santé Et de la Recherche Médicale, France · collab
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2022-06-01
- Primary completion
- 2027-11
- Completion
- 2028-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Rituximab | Monoclonal antibody | 1000 mg | — |