Short-Term Application of Tocilizumab Following Myocardial Infarction

• Status: Completed
• Trial end date: 2017-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Keesler Air Force Base Medical Center

Criteria

Inclusion Criteria:

• Subjects over the age of 18 years old

• Subjects who present to Keesler Medical Center with clinical, physical examination, serologic, and electrocardiographic evidence of an acute MI (NSTEMI or STEMI), as determined by the treating physician

Exclusion Criteria:

• Subjects with clinical, physical examination, or radiographic evidence suspicious for active Tuberculosis (TB)

• Subjects with a known history of Hepatitis B or Hepatitis C infection This exclusion refers specific subjects who are actively being treated with medications for Hepatitis B or C or who have known virologic evidence on ongoing infection with Hepatitis B or C

• Subjects who are immune compromised including transplant recipients, patients with HIV, etc.

• Subjects with evidence of Tuberculosis infection on chest xray

• Subjects with known allergic reaction to tocilizumab or other IL-6 inhibitors

• Subjects with clinical, physical examination, serologic, or radiographic evidence of active infection

• Subjects receiving therapy for malignancy-this will not exclude subjects receiving therapy for non-melanoma skin cancer such as basal cell carcinoma or squamous cell carcinoma of the skin

• Female subjects who are pregnant or breast-feeding

• Subjects with existing cognitive impairment such as known moderate to severe dementia or subjects who present with new onset delirium