EUCTR2007-003026-14-AT进行中（未招募）不适用
/A - Prevention of elastic recoil by urapidil
KA Rudolfstiftung - 2. Medizinische Abteilung0 个研究点目标入组 80 人开始时间: 2008年5月8日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 80
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
- •- coronary artery disease with a single coronary vessel requiring intervention
- •- patients of both sexes between 18 and 80 years of age
- •- stable angina pectoris
- •- regular sinus rhythm in electrocardiogram
- •- body weight = 55 kg and = 100 kg
- •- 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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- contraindication for the IMP
- •- coronary artery disease with more than one coronary vessels requiring intervention
- •- acute coronary syndrome defined as unstable angina pectoris, ST elevation
- •myocardial infarction (STEMI), and non-ST elevation myocardial infarction (STEMI)
- •- concomitant treatment with the following glycoprotein (GP) IIb/IIIa inhibitors:
- •Abciximab (ReoPro®), Ebtafibatid (Integrilin®), or Tirofiban (Agrastat®)
- •- pacemaker patient or patient with implanted cardiac defibrillator
- •- severe aortic stenosis and/or aortic insufficiency, severe mitral stenosis and/or
- •insufficiency
- •- serum creatinin > 1.5 mg/dl
- •- hypotonia (SBP = 100 mmHg measured in lying position)
- •- at least one of the following events within 3 months prior to enrolment date:
- •myocardial infarction, transient ischemic attack (TIA), prolonged ischemic neurological
- •deficit (PRIND), stroke
- •- cardiac ejection fraction < 35%
- •- NYHA class 3 or higher
- •- concomitant treatment with alpha receptor blocking agents within 6 months
- •prior to enrolment date
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