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临床试验/EUCTR2011-005305-73-DE
EUCTR2011-005305-73-DE进行中（未招募）不适用

Effects of clopidogrel vs prasugel vs ticagrelor on endothelial function, inflammatory and oxidative stress parameters and platelet function in patients undergoing coronary artery stenting. A randomised, prospective study. - Endothelium, Stenting, and antiplatelet Therapy (EST) - Clopidogrel, Prasugrel, Ticagrelor study

niversity Medical Center of the Johannes Gutenberg-University Mainz0 个研究点开始时间: 2012年4月3日最近更新:
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试验速览

阶段
不适用
状态
进行中（未招募）
发起方
研究概览入排标准研究者记录与标识符相似试验

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

  • •- 18-75 years old consecutive patients undergoing coronary
  • •angiography and stenting at the University Medical Centre Mainz
  • •- A coronary lesion (and patient) amenable to treatment with drug
  • •eluting stent
  • •- Ability of subject to understand character and individual
  • •consequences of clinical trial
  • •- Signed and dated informed consent of the subject must be
  • •available before start of any specific trial procedures.
  • •- Negative pregnancy test of women with childbearing potential
  • •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 120
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 60

排除标准

  • •- Patients with elevated (>5 times upper normal limit) C-reactive
  • •protein level prior to stenting and an acute infection (elevated CRP in context of ACS is not an exclusion criteria)
  • •- Patients in whom therapy with long-acting nitrates cannot be
  • •suspended prior to endothelial function measurements
  • •- An acute coronary syndrome treated with coronary stenting within the last 4 weeks
  • •- Patients with known inflammatory/infective diseases
  • •- Patients with severe extracardiac diseases limiting life expectancy
  • •- Known heart failure (LV-EF =40% AND NYHA III-IV)
  • •- PCI or coronary By-Pass surgery within the last 4 weeks, preexisting ongoing treatment with any of the study treatments.
  • •- History of cerebrovascular events (stroke)
  • •- Known renal dysfunction (serum creatinine =1.8mg/dl in women, =2.0mg/dl in men)
  • •- Serum potassium >5.5mmol/l
  • •- Known hepatic impairment (AST, ALT >3 times upper limit of
  • •- Changes in the ß-blocker, statin or ACE-inhibitor treatment within the past 2 weeks
  • •- Pregnancy and lactation, inadequate contraception
  • •- Body weight <60kg
  • •- Active bleeding
  • •- Therapy with CYP3A4 inhibitors (ketoconazole, protease inhibitors, macrolide antibiotics)
  • •- Therapy with anticoagulants: phenprocoumone, warfarin,
  • •dabigatran, rivaroxaban
  • •- History of hypersensitivity to any of the investigational medicinal
  • •products or to any drug with similar chemical structure or to any
  • •excipient present in the pharmaceutical form of the investigational
  • •medicinal product.
  • •- Ongoing participation in other clinical trials or within the last 3
  • •months, or ongoing therapy with one of the study medications.
  • •- Medical or psychological condition that would not permit
  • •completion of the trial or signing of informed consent.

研究者

发起方
niversity Medical Center of the Johannes Gutenberg-University Mainz

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