Anti-inflammatory Effects of Intracoronary and Intravenous Abciximab Administration During Primary Percutaneous Coronary Intervention.(Molecole di Adesione Nella Sindrome Coronarica Acuta
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 89
- 试验地点
- 1
- 主要终点
- Change in C-reactive protein levels from baseline after PCI
研究概览
简要总结
Intracoronary abciximab administration during primary percutaneous coronary intervention (pPCI) could offer clinical advantages over the intravenous route. The aim of this study was to assess whether abciximab administration route could influence its anti-inflammatory effects. 87 consecutive STEMI patients candidate to pPCI were randomized to receive an intracoronary or intravenous abciximab bolus. The primary endpoint was the extent of inflammation, measured by C-reactive protein (CRP), VCAM-1 and ICAM-1 levels.
详细描述
BACKGROUND: intracoronary abciximab administration during primary percutaneous coronary intervention (pPCI) could offer clinical advantages over the intravenous route. Besides antiplatelet effects, abciximab can modulate inflammation via cross-reactivity with GPIIb/IIIa, avb3, and aMb2 receptors. The aim of this study was to assess whether abciximab administration route could influence its anti-inflammatory effects.
METHODS: 87 consecutive STEMI patients candidate to pPCI were randomized to receive intracoronary (Group A, 47 patients) or intravenous (Group B, 42 patients) abciximab bolus. The primary endpoint was the extent of inflammation, measured by C-reactive protein (CRP), VCAM-1 and ICAM-1 levels.
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
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •presence of STEMI according to the universal definition of myocardial infarction (7);
- •hospital admission within 12 hours from symptom onset;
- •successful treatment by primary PCI, defined as a procedure achieving infarct-related artery (IRA) patency with less than 10% residual coronary stenosis based on visual estimation.
排除标准
- •age > 90 years;
- •cardiogenic shock at admission;
- •left main as IRA;
- •saphenous vein graft as IRA;
- •previous PCI in the last 6 months;
- •severe renal impairment (eGFR<30ml/min) or dialysis treatment;
- •thrombolytic drug administration in the last 30 days before admission;
- •known malignancy diagnosed less than 5 years before admission;
- •known active infectious, coagulative or systemic inflammatory diseases.
研究组 & 干预措施
Intracoronary abciximab
Intracoronary administration of an abciximab bolus during primary PCI
干预措施: Intracoronary administration of an abciximab bolus during primary PCI (Drug)
Intravenous abciximab
Intravenous standard administration of an abciximab bolus during primary PCI
干预措施: Intravenous administration of an abciximab bolus during primary PCI (Drug)
结局指标
主要结局
Change in C-reactive protein levels from baseline after PCI
时间窗: 48h
C-reactive protein will be evaluated at admission and 48 hours after the primary PCI as marker of the inflammatory reaction
次要结局
- Overall Mortality(1year)
- Target vessel revascularization(1 year)
- Myocardial infarction(1 year)
研究者
Lupi Alessandro
Principal Investigator
Azienda Ospedaliero Universitaria Maggiore della Carita