Myocardial Infarction With ST-elevation Treated by Primary Percutaneous Intervention Facilitated by Early Reopro Administration in Alsace.
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 292
- 试验地点
- 1
- 主要终点
- ST segment regression 1 hour after angioplasty
研究概览
简要总结
Mechanical recanalization of the culprit artery in acute myocardial infarction using stents provides in 2003, TIMI 3 flow restoration in more than 90% of patients. However, the prognosis of this condition remains poor, to a large degree because of microcirculatory dysfunction that is observed, in near than 20 to 40 % of patients, during or following primary percutaneous intervention. The lack of ST-segment elevation resolution after angioplasty with stenting is a marker of microcirculatory dysfunction and is associated with a poor prognosis. Routine administration with primary stenting of the platelet glycoprotein IIb/IIIa inhibitor Abciximab in acute myocardial infarction is still a matter of debate with conflicting results emerging from two major clinical studies ADMIRAL and CADILLAC. However, evidences are in favour of a benefit of this treatment especially when administrated early (in a pre-hospital manner) before percutaneous coronary intervention.Our primary purpose is to investigate the benefit of an early (i.e. pre-hospital) vs. a conventional (i.e. per-angiography) administration of Abciximab on ST-segment elevation regression at one hour after primary percutaneous angioplasty.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years of age eligible for randomization in the MICU
- •Infarct within 6 hours from symptoms onset
- •Continuous typical chest pain symptoms symptoms for more than 20 min. and-ST segment elevation of more than 2 mm in more than two leads (peripheral or precordial)
- •Signed informed consent form
排除标准
- •Ventricular conduction anomalies masking signs of ischemia (left or right bundle branch block without evidence of additional elevation), electrical left ventricular hypertrophy
- •Known hypersensitivity to Abciximab or to any component of the product or to murine monoclonal antibodies.- Hemorrhagic diathesis, internal hemorrhage
- •Hemorrhagic stroke within 2 years
- •Ischemic stroke within the last 3 months- Intra-cranial neoplasm, intracranial malformation or arteria
- •venous aneurysm
- •Recent intracranial or intraspinal surgery or trauma (within two months)
- •Recent within (2 months) major surgery- Known peptic ulcer or upper gastrointestinal bleeding within the previous 6 month
- •Known coagulation anomaly
- •Oral anti-coagulant or low molecular weight heparin treatment- Ongoing thrombolytic treatment
研究组 & 干预措施
1
- Early Abciximab bolus during prehospital transportation in ambulance 0.25 mg/Kg iv with Heparin 40 UI/kg bolus.
- Abciximab placebo bolus and Abciximab infusion 10 µg/Kg/min after coronary angiography and before angioplasty.
干预措施: Abciximab (Drug)
1
- Early Abciximab bolus during prehospital transportation in ambulance 0.25 mg/Kg iv with Heparin 40 UI/kg bolus.
- Abciximab placebo bolus and Abciximab infusion 10 µg/Kg/min after coronary angiography and before angioplasty.
干预措施: Abciximab placebo (Drug)
2
- Abciximab placebo bolus during prehospital transportation in ambulance with Heparin 40 UI/kg bolus.
- Abciximab 0.25 mg/Kg bolus after coronary angiography and before angioplasty followed by Abciximab infusion 10 µg/Kg/min.
干预措施: Abciximab (Drug)
2
- Abciximab placebo bolus during prehospital transportation in ambulance with Heparin 40 UI/kg bolus.
- Abciximab 0.25 mg/Kg bolus after coronary angiography and before angioplasty followed by Abciximab infusion 10 µg/Kg/min.
干预措施: Abciximab placebo (Drug)
结局指标
主要结局
ST segment regression 1 hour after angioplasty
时间窗: 1 hour after angioplasty
次要结局
- Major cardiac events at 1 and 6 month(1 and 6 month)