Intracoronary Bolus Only Compared With Intravenous Bolus and 12-hours Infusion of Abciximab in Non-ST Elevation Myocardial Infarction.
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- In cardiac MRI- infarct size (total late enhancement volume at day 3-7)
研究概览
简要总结
Intracoronary bolus Abciximab single is non-inferior to intravenous and continuous 12- hours infusion in the size reduction of infarction on cardiac magnetic resonance in Non-ST elevation Myocardial infarction.
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
- Single (Participant)
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
- •non-ST segment elevation acute myocardial infarction
- •within 48 hours presence of chest pain
- •Troponin-T or I positive before CAG
- •First myocardial infarction
- •will be performed coronary angioplasty
排除标准
- •under 18 years of age,80 years or older
- •Bleeding tendency
- •History of major surgery within 4 weeks
- •Major stroke within 2 years
- •Thrombocytopenia (<120,000 / uL)
- •Cardiogenic shock
- •Known allergy to aspirin, heparin, or abciximab
- •Contraindication of MRI at study entry (implanted pacemakers, defibrillators, intracranial metallic implants etc)
- •Chronic atrial fibrillation
- •Pregnancy
研究组 & 干预措施
Abciximab IV bolus and 12hr continuous
干预措施: glycoprotein IIb/IIIa inhibitor (abciximab) (Drug)
Abciximab IC bolus
After CAG, For patients with undergoing percutaneous coronary intervention, intracoronary only or intravenous bolus abciximab(0.25mg/kg body weight) administration with intravenous bolus group has subsequent 12-hours continuous infusion at a dose 0.125ug/kg per minute (maximum: 10ug/min)
干预措施: glycoprotein IIb/IIIa inhibitor (abciximab) (Drug)
结局指标
主要结局
In cardiac MRI- infarct size (total late enhancement volume at day 3-7)
时间窗: day 3~7 after percutaneous coronary intervention
MRI: magnetic resonance image
次要结局
- in-hospital and after 1-months:the major adverse cardiovascular events : death, myocardial infarction, hospitalization for heart failure, myocardial ischemia, etc.(1 month)
- b. major bleeding : Hemoglobin 4 or more reduction, 2-unit If you need more than two RBC transfusions, intracranial or retroperitoneal bleeding, urgent operation for bleeding complication.(1 month)
- TIMI III flow count /myocardial blush score after PCI(1 day)
- At cardiac MRI : LV ejection fraction,LV end-systolic volume,LV end diastolic volume,regional wall motion score index(1 week)
- Discharge, 1- month after comparing NT-proBNP(1 month)
研究者
Hyo-Soo Kim
Investigator
Seoul National University Hospital