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

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ClinicalTrials.gov Identifier: NCT01491074
Recruitment Status : Completed
First Posted : December 13, 2011
Last Update Posted : May 19, 2014
Sponsor:
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

Tracking Information
First Submitted Date  ICMJE December 9, 2011
First Posted Date  ICMJE December 13, 2011
Last Update Posted Date May 19, 2014
Study Start Date  ICMJE August 2011
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 12, 2011)
high sensitivity C-reactive protein Area under the curve (AUC) [ Time Frame: 0-56 hrs following inclusion ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01491074 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 12, 2011)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: February 3, 2014)
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
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of the Interleukin-6 Receptor Antagonist Tocilizumab in Non-ST Elevation Myocardial Infarction
Official Title  ICMJE Effect of the Interleukin-6 Receptor Antagonist Tocilizumab in Non-ST Elevation Myocardial Infarction - a Randomized, Double Blind, Placebo Controlled Study.
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Non-ST Elevation Myocardial Infarction
Intervention  ICMJE
  • 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
  • Drug: NaCl 0.9% 100 ml
    Placebo
Study Arms  ICMJE
  • Placebo Comparator: NaCl 0.9% 100 ml
    Intervention: 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
    Intervention: Drug: Tocilizumab 280 mg
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 12, 2011)
120
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2014
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01491074
Other Study ID Numbers  ICMJE 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 )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Oslo University Hospital
Study Sponsor  ICMJE Oslo University Hospital
Collaborators  ICMJE
  • St. Olavs Hospital
  • South-Eastern Norway Regional Health Authority
  • University of Oslo
  • Norwegian University of Science and Technology
Investigators  ICMJE
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
PRS Account Oslo University Hospital
Verification Date May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP