Short-Term Application of Tocilizumab Following Myocardial Infarction
Status:
Completed
Trial end date:
2017-08-01
Target enrollment:
Participant gender:
Summary
Introduction: Interleukin 6 (IL-6) is a cytokine that has a pro-inflammatory effect on the
immune system. In acute MI IL-6 levels rapidly increase in response to ischemia and
inflammation. Tocilizumab is a humanized monoclonal antibody against the interleukin-6
receptor (IL-6R). The use of tocilizumab within the first 24 hours of admission for acute MI
could reduce 30 day mortality.
Methods: This randomized, placebo controlled trial will assign subjects within 24 hours of
admission to treatment with either 162 mg of tocilizumab subcutaneously once or placebo in
addition to usual pharmacologic and interventional standard of care for acute MI (ST segment
elevation MI or non-ST segment elevation MI).
Outcomes: The primary outcome is difference in 30 day (plus/minus 5 days) occurrence of major
adverse cardiac events (as defined later in this protocol) between placebo and Tocilizumab
treated groups. Secondary outcomes to be assessed include length of hospitalization,
readmission rates by day 30, CRP levels at 0 hours, 24 hours, 48 hours, and 30 days following
treatment, and safety of Tocilizumab with focus on rates of known side effects.