A Phase 2 interventional study of Tocilizumab and Sodium chloride 0.9% in Coronary Disease and Myocardial Infarction, sponsored by Oslo University Hospital. Completed at 3 sites in Norway. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-03-02.
Sponsored by Oslo University Hospital · Phase 2, Interventional, and Treatment
The main goal of this study is to evaluate the ability of a single administration of tocilizumab to reduce myocardial damage in patients presenting with an acute ST-segment elevation myocardial infarction (STEMI). Secondary objectives are to assess the impact of treatment on: (i) final infarct size, (ii) left ventricular size and function, (iii) inflammation, (iv) extracellular matrix remodeling, (v) lipid parameters, (vi) platelet activation and additional pro- and anti-thrombotic parameters, and (vii) study drug safety and tolerability.
Myocardial infarction (MI) is a major contributor to morbidity and mortality in the Western world. The main determinant of death and complications is infarct size, and limitation of the infarct size has therefore been an important objective for strategies to improve outcome. In patients presenting with an acute ST segment elevation myocardial infarction (STEMI), urgent myocardial reperfusion with percutaneous coronary intervention (PCI) is the most effective treatment to this end. However, despite PCI, the morbidity and mortality in patients with STEMI remain substantial. This fact suggests that other, adjuvant strategies are required to reduce infarct size and improve outcome. The inflammatory cytokine interleukin (IL)-6 is an important mediator of plaque destabilisation and rupture in acute coronary syndrome (ACS) and may contribute to the ischemia-reperfusion injury succeeding revascularisation. Experimental studies suggest that IL-6 inhibition can limit infarct size through anti-inflammatory mechanisms.(ref)
The investigators recently conducted a double blind, placebo controlled trial in 117 patients with non-ST segment elevation myocardial infarction (NSTEMI) who presented within 72 hour after the onset of chest pain. In this study, a single, intravenous dose of the IL-6 antagonist tocilizumab reduced the inflammatory activity by more than 50% in the days subsequent to the intervention. Importantly, tocilizumab also reduced troponin T (TnT) levels, suggesting that patients receiving tocilizumab sustained less myocardial damage than patients who received placebo.1
Interleukin-6 inhibition might limit infarct size through reduced myocardial inflammation, but theoretically, it could also inhibit the repair process within the injured area. While the recent study suggests that IL-6 inhibition has largely favourable effects in NSTEMI, it remains to be seen if similar, beneficial effects can be obtained in patients with STEMI. On this background, the investigators want to investigate the effect of tocilizumab in patients with acute STEMI. The postulate is that a single dose of tocilizumab (RoActemra®) will have favourable effects on infarct size, as assessed by markers of myocardial necrosis and cardiac magnetic resonance imaging (CMR), without negative consequences for the repair process in these patients. The hypothesis will be tested in a randomised, double blind, placebo controlled trial comprising 200 patients with acute STEMI.
This is a phase 2 study on a new and exciting anti-inflammatory strategy in cardiovascular disease. It will be conducted at three experienced, high volume centres in Norway, and will target new and yet unmodified mechanisms during myocardial infarction. The ambition is to improve the prognosis of patients with ACS, with potential to change clinical practice.
2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.
This study's enrollment of 200 is above the median of 148 across 1,595 interventional studies indexed under Myocardial Infarction.
Browse Myocardial Infarction studies →Oslo University Hospital is the lead sponsor of 810 studies on the registry; 148 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients will be screened for eligibility upon admittance due to acute STEMI at either participating site. All of the following conditions must apply to the prospective patient at screening prior to receiving study agent:
Exclusion Criteria:
Patients will be excluded from the study if they meet any of the following criteria:
Tocilizumab, 20 mg/ml; 14 ml (280 mg) dissolved in 100 ml NaCl 0.9 % i.v. once.
Drug: Tocilizumab
Sodium chloride 0.9%; 100 ml i.v. once.
Drug: Sodium chloride 0.9%
Active drug: Tocilizumab, 20 mg/ml; 14 ml (280 mg) dissolved in 100 ml NaCl 0.9 % i.v. once.
Also known as: RoActemra®,
Placebo: Sodium chloride 0.9%; 100 ml i.v. once.
Also known as: NaCl 0.9%
The primary endpoint will be the between-group difference in the myocardial salvage index as measured in the acute phase by cardiac magnetic resonance (CMR) imaging with late gadolinium enhancement (LGE).
Time frame: 6 months
The between-group difference in the AUC for Troponin T (TnT) during index hospitalisation
Time frame: 24 -72 hours after randomisation
The extent of microvascular obstruction as measured by CMR after 3 - 7 days
Time frame: 3 - 7 days after randomisation
Final infarct size as measured by CMR 6 months after randomisation
Time frame: 6 months after randomisation
Left ventricular size as assessed by CMR 6 months after randomisation
Time frame: 6 months after randomisation
Baseline-adjusted NT-proBNP at 6 months after randomisation
Time frame: 6 months after randomisation
The AUC of Creatine Kinase-MB (CK-MB) during index hospitalisation
Time frame: 24-72 hours after randomisation
The AUC of C-reactive protein (CRP) during index hospitalisation
Time frame: 24-72 hours after randomisation
Plan to share: Undecided — Undecided
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Oslo University Hospital