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NCT Number: NCT01491074

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

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.

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Key information

Conditions

Non-ST Elevation Myocardial Infarction Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Non-ST Elevated Myocardial Infarction Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Oslo University Hospital, Oslo, Norway

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • NSTEMI (ESC Type 1)
  • Age 18-80 years
  • Troponin T >/= 30 ng/ml
  • Informed consent to participation

Exclusion criteria

  • STEMI
  • Known cardiac disease, except coronary disease (cardiomyopathy, heart failure with known EF < 45%, severe valvular heart disease attending regular follow-up, recent PCI/ACB (< 3 months))
  • Hemodynamic and/or respiratory instability
  • Cardiac arrest in acute phase
  • Concurrent condition affecting/potentially affecting CRP (infection, malignancy, autoimmune disease)
  • Recent major surgery (< 3 months)
  • Recent/concurrent immunosuppressant treatment (< 2 weeks, except NSAIDs)
  • Severe renal failure (eGFR < 30 ml/min)
  • Pregnancy
  • Contraindications to any study investigations and/or medication.
  • Expected non-adherence to study protocol

Treatment and study plan

Tocilizumab 280 mg

Drug

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

Other names: Brand name RoActemra (Roche), ATC: L04A C07

NACL 0.9% 100 ml

Drug

Placebo

Primary outcomes

  1. high sensitivity C-reactive protein Area under the curve (AUC)

    Time frame: 0-56 hrs following inclusion

Secondary outcomes

  1. hs troponin T

    Time frame: 0-56 hrs, 3 months and 6 months following inclusion

  2. hs CRP

    Time frame: 3 and 6 months following inclusion

  3. pro-BNP

    Time frame: 0-56 hrs, 3 and 6 months

  4. Infarct size

    Time frame: 6 months

    Assessed by Echocardiography and MRI at 6 months

  5. LV size

    Time frame: acute phase (0-3 days), 6 months

    Assessed by echocardiography

  6. LV function

    Time frame: acute phase (0-3 days), 6 months

    Assessed by echocardiography, cardiac MRI at 6 months

  7. Coronary flow reserve

    Time frame: acute phase (0-3 days), 6 months

    Assesses coronary microvascular function - for 60 patients only.

  8. Endothelial function

    Time frame: Acute phase (0-3 days) and 6 months

    Assessed by tonometry

Other outcomes

  1. Other inflammatory pathways

    Time frame: 0-56 hrs, 3 monhts, 6 months

    TNF-alfa, IL-1, IL-6, IL-18, platelet-derived inflammatory mediators, anti-inflammatory cytokines etc

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • Norwegian University of Science and Technology
  • South-Eastern Norway Regional Health Authority
  • St. Olavs Hospital
  • University of Oslo

Registry information

Official study title

Effect of the Interleukin-6 Receptor Antagonist Tocilizumab in Non-ST Elevation Myocardial Infarction - a Randomized, Double Blind, Placebo Controlled Study.

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Dec 13, 2011
Registry last updated
May 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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