EUCTR2012-001584-77-DE
进行中（未招募）
不适用
Effect of Ranolazine in ischemic patients with indication of staged interventional therapy - ERASER
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Stable Angina Pectoris
- 发起方
- Menarini International Operations Luxembourg S.A.
- 状态
- 进行中（未招募）
- 最后更新
- 10年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •Subjects must meet all of the following inclusion criteria to be eligible for participation in this study.
- •1\.Male and female patients (females of childbearing potential must have a negative urine pregnancy test and must be using adequate contraceptive precautions, see also section 17\.4\)
- •2\.Performed coronary angiography with or without initial PCI more than 24 hours before MRI
- •3\.Remaining \= 70% stenosis of a coronary artery bigger than 2 mm diameter (not corrected by PCI)
- •4\.Indication of further interventional treatment
- •5\.Wall motion abnormalities in at least one segment; if segment 17 is affected, an additional segment has to show wall motion abnormalities (for the segment\-model, see section 13\.3\.3\)
- •6\.History of chronic angina pectoris
- •7\.Age \= 18 years
- •8\.Normalized blood pressure \< 140/90 mmHg and heart rate \< 70 bpm and \= 50 bpm at rest
- •9\.Sinus rhythm
排除标准
- •Subjects who meet any of the following exclusion criteria are not enrolled in this study:
- •1\.Cardiac instability, e.g. acute coronary syndrome as indication for the coronary angiography (ST\-elevation or positive troponin testing)
- •2\.Contraindication for MRI (e.g. implanted pace maker, internal defibrillator, MRI incompatible devices or metals)
- •3\.Contraindication for dobutamine, atropine, gadolinium based contrast agent, or metoprolol
- •4\.Patients with heart failure classification NYHA III and NYHA IV
- •5\.Myocardial infarction during the last 3 days prior to treatment with ranolazine
- •6\.Severe renal impairment (GFR \< 30 ml/min)
- •7\.Moderate or severe hepatic impairment (ALT or AST \> 2\.5× upper normal limit)
- •8\.Allergic asthma bronchiale
- •9\.Hyperthyroidism or Hashimoto thyreoiditis
结局指标
主要结局
未指定
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