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
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- •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
- •10.Standard therapy: beta-blocker and/or calcium channel blocker (stable for 4 weeks)
- •11.Signed 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 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
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
- •10.Myocarditis or inflammatory heart disease
- •11.Hypertrophic obstructive cardiomyopathy
- •12.Concomitant administration of class Ia (e.g. quinidine) or class III (e.g. dofetilide, sotalol) antiarrhythmics, except for amiodarone
- •13.Long acting nitrates
- •14.Concomitant treatment with potent inhibitors of CYP3A (see also section 11.4)
- •15.Concomitant treatment with CYP3A inducers (see also section 11.4)
- •16.Dronedarone
- •17.Use of greater than 1000 mg daily dose of metformin during the study
- •18.Hypersensitivity to the active substance or to any of the excipients
- •19.Hypersensitivity to dobutamine, atropine, gadolinium based contrast agent, or metoprolol
- •20.Concomitant administration of > 20 mg simvastatin/day
- •21.History of ECG abnormalities that, in the opinion of the investigator, render the patient unsuitable for the trial, e.g. history of long QT syndrome or significant prolonged QT interval (> 120%)
- •22.Participation in another trial of an investigational drug or device within 30 days prior to screening
- •23.Pregnant and breast-feeding women (females of childbearing potential or within two years from the menopause must have a negative urine pregnancy test)
- •24.Less than 3 months since delivery, abortion, or lactation before the first screening/examination visit
- •25.Severe psychiatric disorders/neurological disorders
- •26.Suspected abuse of alcohol, analgesics or psychotropic drugs
- •27.Disabling or terminal illness
- •28.Inability or unwillingness to issue the informed consent
研究者
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