EUCTR2014-005363-33-NL进行中（未招募）1 期
Reducing Micro Vascular dysfunction In revascularized STEMI patients by off-target properties of ticagrelor - REDUCE-MVI
VU university medical center0 个研究点目标入组 110 人开始时间: 2015年4月16日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 110
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1.Provision of informed consent
- •2.Patients presenting with STEMI <12 hours
- •3.Successful PCI of the infarct-related vessel with a modern DES
- •4.Intermediate stenosis in non-infarct-related vessel (50-90%)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 70
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •1.history of myocardial infarction
- •2.Participation in another clinical study with an investigational product during the preceding 30 days
- •3.history of cerebrovascular accident (CVA) or 'transient ischaemic attack' (TIA)
- •4.History of intracranial haemorrhage
- •5.indication or use of oral anticoagulant therapy (i.e. acenocoumarol)
- •6.severe liver dysfunction (Child-Pughscore 10–15)
- •7.congestive heart failure
- •8.cardiogenic shock
- •9.left ventricular ejection fraction < 35%
- •10.bleeding diathesis
- •11.age = 75 or < 18
- •12.body weight < 60 kg
- •14.coagulation disorders
- •15.severe pulmonary disease
- •16.pregnancy and breast feeding
- •17.limited life expectancy
- •18.platelet count < 100 000/mm3
- •19.history of drug addiction or alcohol abuse in the past 2 years
- •20.need for chronic nonsteroidal anti-inflammatory drug
- •21.creatinine clearance <30 mL/min or dialysis
- •22.chronic total occlusion (CTO)
- •23.Left main disease
- •24.allergy or contra-indication for ticagrelor or prasugrel
- •25.Contra-indication for adenosine
- •26.Patients unable to be followed on-site
- •27.Unable to undergo or contra-indications for MRI
- •28.Contra-indication for DES
- •29.Inability to obtain informed consent
研究者
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