Short-Term Application of Tocilizumab Following Myocardial Infarction

NCT02419937 | Completed Results

• 1 other identifier: FKE20140029H
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Major Adverse Cardiovascular Events (MACE)

  30 day rate of major adverse cardiac events (MACE) following administration of Tocilizumab subcutaneously single dose within 24 hours of NSTEMI or STEMI as compared to administration of placebo

  30 days after one time injection

Study Arms (2)

Tocilizumab

ACTIVE COMPARATOR

Blinded subjects will be randomized to tocilizumab 162 mg subcutaneously once.

Drug: Tocilizumab

Placebo

PLACEBO COMPARATOR

Blinded subjects will be randomized to placebo

Drug: Placebo

Interventions

Tocilizumab DRUG

162 mg subcutaneously once (vs. 0.9% normal saline placebo injection once in placebo arm)

Also known as: Actemra

Tocilizumab

Placebo DRUG

Saline injection

Placebo

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Keesler Air Force Base Medical Center: lead

Study Sites (1)

Keesler Medical Center

Keesler Air Force Base, Mississippi, 39534, United States

Location

Related Publications (1)

• Carroll MB, Haller C, Smith C. Short-term application of tocilizumab during myocardial infarction (STAT-MI). Rheumatol Int. 2018 Jan;38(1):59-66. doi: 10.1007/s00296-017-3842-y. Epub 2017 Oct 24.

  PMID: 29067495 DERIVED

MeSH Terms

Conditions

Myocardial Infarction

Interventions

tocilizumab

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Results Point of Contact

• Title: Dr. Matthew B. Carroll
• Organization: United States Air Force

mcar100210@yahoo.com

228-376-3829

Study Officials

• Matthew B Carroll, MD

  Keesler Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2015
• First Posted: April 17, 2015
• Study Start: May 1, 2015
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: November 17, 2017
• Results First Posted: November 17, 2017

Record last verified: 2017-10

Locations

US (1)