NCT01179776已完成1 期
A Single Center, Open, Randomized, Placebo-controlled Study Investigating the Safety of Administration of Ilomedin® in Addition to Standard Treatment in Patients Having Undergone Primary Percutaneous Coronary Intervention (PCI)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Bleeding complications as evaluated by TIMI and GUSTO criteria
研究概览
简要总结
Acute myocardial infarct patients with STEMI (ST-elevation on ECG) whom undergo a primary percutaneous cardiac intervention will following the standard treatment , received low dose of Ilomedin and to low dose of standard treatment for another 24 hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Age > 18 years
- •Undergoing primary PCI due to STEMI (TIMI flow I -III before PCI and symptom duration < 12 hours)
- •Following receipt of verbal and written information about the study, the patient must provide signed informed consent before any study data is used.
排除标准
- •Not able to give informed consent 3) Women with childbearing potential 4) On-going concomitant treatment with K-vitamin antagonists (one bolus dose pre-PCI allowed) 5) Known congenital or acquired coagulopathy and/or thrombocytopathy s 8) Participation in a clinical study and/or another investigational device within the past four weeks prior to Day 1 9) Major surgery or trauma within the past 6 weeks prior to Day 1 10) A blood coagulation disorder (i.e. international normalized ratio [INR] > 2.0, platelet count < 100,000/mm3, or hematocrit < 30%) 11) Renal insufficiency (creatinine > 140 mmol/l) 12) Major procedure related bleeding (TIMI major criteria); GI or urinary tract bleeding prior to inclusion in the trial 13) Known active hepatitis B and/or hepatitis C or HIV 14) Known or suspected hypersensitivity to components of the investigational medicinal product
研究组 & 干预措施
Ilomedin and standard low dose treatment
Experimental
干预措施: Ilomedin (Drug)
Ilomedin and standard low dose treatment
Experimental
干预措施: Ilomedin and standard low dose treatment (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Bleeding complications as evaluated by TIMI and GUSTO criteria
时间窗: Feb 2011
Increased bleeding complications will be evaluated between the active and placebo groups.
次要结局
- Endothelial markers and blood aggregation (measured by TEG and multiplate)(Feb 2011)
研究者
研究点 (1)
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进行中（未招募）
不适用
Acute STEMI treated with primary angioplasty and intravenous enoxaparin orUFH to lower ischemic and bleeding events at short- and long-term follow-up. - ATOEUCTR2007-007676-42-DEASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)910
进行中（未招募）
不适用
Acute STEMI treated with primary angioplasty and intravenous enoxaparin orUFH to lower ischemic and bleeding events at short- and long-term follow-up. - ATORandomized evaluation of enoxaparin versus unfractioned heparine (UFH) withGPIIb/IIIa inhibitors70-100IU without GPIIb/IIIa inhibitors) in patients showing an acute ST elevation myocardial Infarction (STEMI). All STEMIs will be treated by fibrinolysis followed by a percutaneous transluminal coronary intervention (PCI).MedDRA version: 9.1Level: LLTClassification code 10064345Term: ST segment elevation myocardial infarctionEUCTR2007-007676-42-ATASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)910