EUCTR2013-001636-22-DE进行中（未招募）1 期
A prospective, randomized, parallel-group, open label, non-inferiority, multicenter trial of a 12 month vs. a short-term platelet function testing guided prasugrel therapy in acute coronary syndrome patients undergoing coronary stenting
Hospital of the University of Munich, Grosshadern0 个研究点目标入组 2,600 人开始时间: 2013年6月25日最近更新:
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
- 2,600
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
- 性别
- All
入选标准
- •- Patients with troponin positive ACS
- •- Successful PCI (defined as a post PCI diameter stenosis <20% and TIMI flow >=2)
- •- A planned treatment of prasugrel for 12 month after the procedure
- •- Written informed consent
- •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 1500
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1100
排除标准
- •- Age < 18 years and > 80 years
- •- Subjects with known contraindications to clopidogrel treatment, which are hypersensitivity to the drug substance or any component of the product and active pathological bleeding such as peptic ulcer or intracranial hemorrhage
- •- Subjects with known contraindications to prasugrel treatment, which are hypersensitivity to the drug substance or any component of the product, active pathological bleeding such as peptic ulcer or intracranial hemorrhage and a history of prior transient ischemic attack (TIA) or stroke
- •- Subjects with a history of a complicated or prolonged cardiogenic shock in the last two weeks prior to the beginning of this clinical trial. A complicated or prolonged cardiogenic shock is defined by a cardiogenic shock that required mechanical ventilation or the cardiovascular support with positive inotropic drugs (i.v. catecholamines) for =7 days.
- •- Subjects requiring concomitant treatment with an anticoagulant agent (Vitamin-K antagonists or novel oral anticoagulants such as rivaroxaban, dabigatran or apixaban)
- •- Indication for major surgery (per decision of the treating physician) for the planned duration of the study
- •- Simultaneous participation in another clinical trial that involveds the administration of an investigational medicinal drug within 30 days prior to the beginning of this clinical trial
- •- Known or persistent abuse of medication, drugs or alcohol
- •- Current or planned pregnancy or nursing women, women 90 days after childbirth. Females of childbearing potential, who do not use and are not willing to use medically reliable methods of contraception for the entire study duration (such as oral, injectable, or implantable contraceptives, or intrauterine devices) unless they are surgically sterilized/hysterectomized or there are any other criteria considered sufficiently reliable by the investigator`s opinion
- •- Evidence of significant active neuropsychiatric disease, in the investigator´s opinion
研究者
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