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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01491074
Recruitment Status : Completed
First Posted : December 13, 2011
Last Update Posted : May 19, 2014
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Non-ST Elevation Myocardial Infarction Drug: Tocilizumab 280 mg Drug: NaCl 0.9% 100 ml Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of the Interleukin-6 Receptor Antagonist Tocilizumab in Non-ST Elevation Myocardial Infarction - a Randomized, Double Blind, Placebo Controlled Study.
Study Start Date : August 2011
Primary Completion Date : November 2013
Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: NaCl 0.9% 100 ml Drug: NaCl 0.9% 100 ml
Experimental: Tocilizumab 280 mg
Intravenous infusion, 280 mg Tocilizumab (14 ml) added to 86 ml of 0.9% NaCl
Drug: Tocilizumab 280 mg
Intravenous administration of 280 mg Tocilizumab (14 ml), mixed with 86 ml 0.9% NaCl
Other Names:
  • Brand name RoActemra (Roche)
  • ATC: L04A C07

Outcome Measures

Primary Outcome Measures :
  1. high sensitivity C-reactive protein Area under the curve (AUC) [ Time Frame: 0-56 hrs following inclusion ]

Secondary Outcome Measures :
  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 Outcome Measures:
  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

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01491074

St Olavs Hospital
Trondheim, Sør-Trøndelag, Norway, 7006
Oslo University Hospital
Oslo, Norway, 0424
Sponsors and Collaborators
Oslo University Hospital
St. Olavs Hospital
South-Eastern Norway Regional Health Authority
University of Oslo
Norwegian University of Science and Technology
Principal Investigator: Lars Gullestad, MD, PhD Oslo University Hospital
Study Chair: Rune Wiseth, MD, PhD St. Olavs Hospital
Study Chair: Pål Aukrust, MD, PhD Oslo University Hospital
Study Chair: Jan K Damås, MD, PhD St. Olavs Hospital
More Information

Responsible Party: Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01491074     History of Changes
Other Study ID Numbers: 2010/1971 [REK]
2010-021953-37 ( EudraCT Number )
2010/1971 ( Registry Identifier: REK )
10/15070-4 ( Registry Identifier: SLV )
4947 ( Other Grant/Funding Number: HSØ )
2010/19043 ( Other Identifier: PVO )
First Posted: December 13, 2011    Key Record Dates
Last Update Posted: May 19, 2014
Last Verified: May 2014

Additional relevant MeSH terms:
Myocardial Infarction
Non-ST Elevated Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases