Effect of the Interleukin-6 Receptor Antagonist Tocilizumab in Non-ST Elevation Myocardial Infarction - a Randomized, Double Blind, Placebo Controlled Study.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- high sensitivity C-reactive protein Area under the curve (AUC)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •NSTEMI (ESC Type 1)
- •Age 18-80 years
- •Troponin T >/= 30 ng/ml
- •Informed consent to participation
排除标准
- •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
研究组 & 干预措施
NaCl 0.9% 100 ml
干预措施: NaCl 0.9% 100 ml (Drug)
Tocilizumab 280 mg
Intravenous infusion, 280 mg Tocilizumab (14 ml) added to 86 ml of 0.9% NaCl
干预措施: Tocilizumab 280 mg (Drug)
结局指标
主要结局
high sensitivity C-reactive protein Area under the curve (AUC)
时间窗: 0-56 hrs following inclusion
次要结局
- pro-BNP(0-56 hrs, 3 and 6 months)
- Infarct size(6 months)
- hs CRP(3 and 6 months following inclusion)
- hs troponin T(0-56 hrs, 3 months and 6 months following inclusion)
- LV size(acute phase (0-3 days), 6 months)
- LV function(acute phase (0-3 days), 6 months)
- Coronary flow reserve(acute phase (0-3 days), 6 months)
- Endothelial function(Acute phase (0-3 days) and 6 months)