drugset / Trial / NCT03072199

Rituximab in Patients With Acute ST-elevation Myocardial Infarction Study

NCT03072199 ↗

Phase 1/2 Completed 24 enrolled Papworth Hospital NHS Foundation Trust
NaSingle-groupOpen-labelTreatment

Summary

RITA-MI aims to develop of a novel therapeutic concept to target the immune response in patients with acute myocardial infarction (MI) by depleting B-cells with a single injection of Rituximab which is approved for clinical use in cancer, autoimmune disease and inflammatory conditions. The goal is to re-purpose the drug, and translate the discovery into benefit for patients at high risk of cardiovascular events. Rituximab is expected to limit infarction size and improve the healing process, as complementary to other therapeutic strategies. The applicants intend to perform a clinical study in patients with acute myocardial infarction (MI). The objective is to find the optimal dose (lowest dose with highest biological efficacy and best safety profile) for peripheral blood B cell depletion during the first 6 days after injection, and selective molecular signatures associated with improved heart function through analysis of peripheral blood samples. The study rationale is to decrease the inflammatory reaction upon tissue necrosis following heart muscle ischemia.

Timeline

Start
2017-06-01
Primary completion
2019-03-01
Completion
2021-05-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Rituximab Monoclonal antibody 200 mg Intravenous
Subject Rituximab Monoclonal antibody 500 mg Intravenous
Subject Rituximab Monoclonal antibody 700 mg Intravenous
Subject Rituximab Monoclonal antibody 1000 mg Intravenous