NCT02739711进行中（未招募）4 期
Prospective RandomizEd Study Comparing Glycoprotein IIb/IIIa Inhibitors VERsus Standard Therapy in PatientS with Myocardial Infarction and Angiographic Evidence of No-reFLOW
University of Luebeck1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2016年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Infarct size assessed by cardiac magnetic resonance imaging
研究概览
简要总结
Aim of the study is to examine the effects of glycoprotein IIb/IIIa inhibitors on reperfusion success assessed by cardiac magnetic resonance imaging in patients with myocardial infarction and angiographic evidence of no-reflow.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ST-elevation myocardial infarction and non-ST-elevation myocardial infarction <48 h after symptom onset
- •Angiographic evidence of no-reflow (Thrombolysis in Myocardial Infarction-flow grade ≤2) after primary percutaneous coronary intervention
- •Age ≥18 years
- •Informed consent
排除标准
- •ST-elevation myocardial infarction and non-ST-elevation myocardial infarction patients with Thrombolysis in Myocardial Infarction-flow 3 after primary percutaneous coronary intervention
- •Age ≤18 years
- •Known pregnancy, breast-feeding or intend to become pregnant during the study period
- •Contraindication for treatment with platelet inhibitors
- •Known allergy to glycoprotein IIb/IIIa inhibitors, aspirin, or heparin
- •Active peptic gastric or duodenal ulcer
- •History of major surgery (including intracranial or intraspinal) <4 weeks
- •Active bleeding or bleeding diathesis
- •Stroke <2 years (ischemic and hemorrhagic)
- •Known coagulation defect or relevant thrombocytopenia
- •Arteriovenous malformations or aneurysm
- •Severe liver insufficiency
- •Renal insufficiency requiring dialysis
- •Uncontrolled hypertension
- •Hypertensive retinopathy
- •Vasculitis
- •Fibrinolysis <12 hours
- •Contraindication for cardiac magnetic resonance imaging at study entry
- •Patients without informed consent
- •Participation in another trial
研究组 & 干预措施
Glycoprotein IIb/IIIa inhibitor
Active Comparator
Glycoprotein IIb/IIIa inhibitor administration
干预措施: Glycoprotein IIb/IIIa inhibitors (Drug)
结局指标
主要结局
Infarct size assessed by cardiac magnetic resonance imaging
时间窗: Day 1-10 after myocardial infarction
次要结局
未报告次要终点
研究者
Prof. Dr. med. Ingo Eitel
Director, Department of Cardiology/Angiology/Intensive Care Medicine, University Heart Center Luebeck
University of Luebeck
研究点 (1)
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