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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01491074
First Posted: December 13, 2011
Last Update Posted: May 19, 2014
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.
Collaborators:
St. Olavs Hospital
South-Eastern Norway Regional Health Authority
University of Oslo
Norwegian University of Science and Technology
Information provided by (Responsible Party):
Oslo University Hospital
  Purpose

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 Intervention Phase
Non-ST Elevation Myocardial Infarction Drug: Tocilizumab 280 mg Drug: NaCl 0.9% 100 ml Phase 2

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

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

Secondary Outcome Measures:
  • hs troponin T [ Time Frame: 0-56 hrs, 3 months and 6 months following inclusion ]
  • hs CRP [ Time Frame: 3 and 6 months following inclusion ]
  • pro-BNP [ Time Frame: 0-56 hrs, 3 and 6 months ]
  • Infarct size [ Time Frame: 6 months ]
    Assessed by Echocardiography and MRI at 6 months

  • LV size [ Time Frame: acute phase (0-3 days), 6 months ]
    Assessed by echocardiography

  • LV function [ Time Frame: acute phase (0-3 days), 6 months ]
    Assessed by echocardiography, cardiac MRI at 6 months

  • Coronary flow reserve [ Time Frame: acute phase (0-3 days), 6 months ]
    Assesses coronary microvascular function - for 60 patients only.

  • Endothelial function [ Time Frame: Acute phase (0-3 days) and 6 months ]
    Assessed by tonometry


Other Outcome Measures:
  • 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


Enrollment: 120
Study Start Date: August 2011
Study Completion Date: April 2014
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: NaCl 0.9% 100 ml Drug: NaCl 0.9% 100 ml
Placebo
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
  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


Locations
Norway
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
Investigators
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 Submitted: December 9, 2011
First Posted: December 13, 2011
Last Update Posted: May 19, 2014
Last Verified: May 2014

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