Rituximab in Patients With Acute ST-elevation Myocardial Infarction Study

Sponsor
Papworth Hospital NHS Foundation Trust
Study ID
NCT03072199
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Inflammation
  • Ischemic Heart Disease
  • Myocardial Infarction

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • RiTUXimab Injection — DRUG
    Single dose of Rituximab given intravenously within 48hours of myocardial infarction

Study Details

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.

Key Dates

Start date
Jun 1, 2017
Status verified
Sep 2021
Primary completion
Mar 1, 2019
Completion
May 1, 2021

Study Design

Enrollment
24 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Rituximab

Primary Outcome Measure

Safety - Review of Adverse Events and Serious Adverse Events; [ Time Frame: 6month ]

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