NCT03072199

Rituximab in Patients With Acute ST-elevation Myocardial Infarction Study

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Papworth Hospital NHS Foundation Trust · Other Government
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ischemic Heart Disease
• Myocardial Infarction
• Inflammation

Interventions

Type	Name	Description
DRUG	RiTUXimab Injection	Single dose of Rituximab given intravenously within 48hours of myocardial infarction

Timeline

• Start date: 2017-06-01
• Primary completion: 2019-03-01
• Completion: 2021-05-01
• First posted: 2017-03-07
• Last updated: 2021-09-14

Locations

1 site across 1 country: United Kingdom