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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
120
Intravenous administration of 280 mg Tocilizumab (14 ml), mixed with 86 ml 0.9% NaCl
Placebo
Oslo University Hospital
Oslo, Oslo, Norway
St Olavs Hospital
Trondheim, Sør-Trøndelag, Norway
high sensitivity C-reactive protein Area under the curve (AUC)
Time frame: 0-56 hrs following inclusion
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
Assessed by Echocardiography and MRI at 6 months
Time frame: 6 months
LV size
Assessed by echocardiography
Time frame: acute phase (0-3 days), 6 months
LV function
Assessed by echocardiography, cardiac MRI at 6 months
Time frame: acute phase (0-3 days), 6 months
Coronary flow reserve
Assesses coronary microvascular function - for 60 patients only.
Time frame: acute phase (0-3 days), 6 months
Endothelial function
Assessed by tonometry
Time frame: Acute phase (0-3 days) and 6 months
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