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Effect of the Interleukin-6 Receptor Antagonist Tocilizumab in Non-ST Elevation Myocardial Infarction

NCT01491074 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2014-05-19

No results posted yet for this study

Summary

Acute coronary syndromes (ACS) are still associated with high morbidity and mortality, despite several improvements in their management. This may indicate that important pathogenic mechanisms contribute to both stable and unstable atherosclerotic disease mechanisms.

Based upon previous research, the investigators believe that providing a block in the damaging inflammatory loop though short term inhibition of Interleukin-6 receptor signalling, could be an attractive therapeutic target in ACS; and of particular interest in patients with non-ST elevation myocardial infarction (NSTEMI), a disease often characterized by widespread coronary inflammation with multiple unstable plaques.

The investigators hypothesize that a single administration of the anti-Interleukin 6 receptor antagonist Tocilizumab, in patients with NSTEMI, may interrupt the self-perpetuating inflammatory loops which could improve plaque stability, with potential secondary beneficial effects on myocardial damage.

This will be investigated in a randomized, double blind, placebo-controlled study, including a total of 120 patients.

Conditions

  • Non-ST Elevation Myocardial Infarction

Interventions

DRUG

Tocilizumab 280 mg

Intravenous administration of 280 mg Tocilizumab (14 ml), mixed with 86 ml 0.9% NaCl

DRUG

NaCl 0.9% 100 ml

Placebo

Sponsors & Collaborators

  • St. Olavs Hospital

    collaborator OTHER

  • South-Eastern Norway Regional Health Authority

    collaborator OTHER

  • University of Oslo

    collaborator OTHER

  • Norwegian University of Science and Technology

    collaborator OTHER

  • Oslo University Hospital

    lead OTHER

Principal Investigators

  • Lars Gullestad, MD, PhD · Oslo University Hospital

  • Rune Wiseth, MD, PhD · St. Olavs Hospital

  • Pål Aukrust, MD, PhD · Oslo University Hospital

  • Jan K Damås, MD, PhD · St. Olavs Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2013-11-30
Completion
2014-04-30

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01491074 on ClinicalTrials.gov