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

University of Oslo (UIO)

Status and phase: Completed; Phase 2

Conditions: Non-ST Elevation Myocardial Infarction

Treatments: Drug: Tocilizumab 280 mg; Drug: NaCl 0.9% 100 ml

Study type: Interventional

Funder types: Other

Identifiers

NCT01491074

10/15070-4 (Registry Identifier)

2010/1971 [REK]

2010/1971 (Registry Identifier)

2010/19043 (Other Identifier)

4947

2010-021953-37 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 2 patient groups, including a placebo group

NaCl 0.9% 100 ml

Placebo Comparator group

Treatment:

Drug: NaCl 0.9% 100 ml

Tocilizumab 280 mg

Experimental group

Description:

Intravenous infusion, 280 mg Tocilizumab (14 ml) added to 86 ml of 0.9% NaCl

Treatment:

Drug: Tocilizumab 280 mg