Short-Term Application of Tocilizumab Following Myocardial Infarction

Part of paid clinical trials in Keesler Air Force Base, Mississippi.

Sponsor
Keesler Air Force Base Medical Center
Study ID
NCT02419937
Status
Completed

Conditions

  • Myocardial Infarction

Eligibility Criteria

Sex
ALL
Age
18 Years - 89 Years
Healthy Volunteers
Not accepted

Interventions

  • Tocilizumab — DRUG
    162 mg subcutaneously once (vs. 0.9% normal saline placebo injection once in placebo arm)
  • Placebo — DRUG
    Saline injection

Study Details

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.

Key Dates

Start date
May 31, 2015
Status verified
Oct 2017
Primary completion
Aug 31, 2017
Completion
Aug 31, 2017

Study Design

Enrollment
28 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Tocilizumab
    Blinded subjects will be randomized to tocilizumab 162 mg subcutaneously once.
  • Placebo Comparator: Placebo
    Blinded subjects will be randomized to placebo

Primary Outcome Measure

Number of Participants With Major Adverse Cardiovascular Events (MACE) [ Time Frame: 30 days after one time injection ]

Locations (1)

FacilityCityStateZIPSite coordinators
Keesler Medical CenterKeesler Air Force BaseMississippi39534-

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