EUCTR2005-004218-34-DE进行中（未招募）1 期
Effect of extended-release niacin on myocardial blood flow and flow reserve in patients with coronary artery disease treated with statins - NIFLO
Department of Cardiology, UK Aachen0 个研究点目标入组 46 人开始时间: 2006年2月6日最近更新:
适应症
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
- 46
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
- •1.Age >35years.
- •2.Male or female patients are eligible. Female patients must be either post-menopausal for one year, surgically sterile, or using effective contraceptive methods such as oral contraceptives, barrier method with spermicide or an intrauterine device.
- •3.CAD, angiographically documented
- •4.HDL-C <45mg%
- •5.LDL-C <150mg%
- •6.Current treatment with statin (allowed are: Lovastatin, daily dose =40mg; Simvastatin, daily dose =40mg; Pravastatin, daily dose =40mg; Fluvastatin, daily dose =40mg; Atorvastatin, daily dose =40mg)
- •7.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
- •1.Intolerance to niacin
- •2.Significant liver disease or liver dysfunction (present or history)
- •3.Active peptic ulcer disease within 3 months
- •4.Arterial bleeding
- •5.Known Ethanol abuse
- •6.Abnormal liver enzymes (>3x upper normal reference value)
- •7.Hereditary muscle disease
- •8.History of myopathy or myositis under HMG-CoA-Reductase-Inhibitor or fibrate
- •9.Abnormal serum creatine-kinase (>3x upper normal reference value)
- •10.Concomitant use of medication with a high probability of increasing the risk for hepatotoxicity or myopathy, such as those predominantly metabolized by cytochrome P450 system 3A4, including fibrates, cyclosporine, amiodarone, verapamil, diltiazem, itraconazole, ketoconazole, erythromycin, clarithromycin, telithromycine, human immunodeficiency virus protease inhibitors, nefazodone, danazol; lipid-lowering drugs such as bile-acid sequestrants, cholesterol absorption inhibitors (e.g., ezetimibe); high-dose, antioxidant vitamins (vitamins C, E, or beta carotene) that can interfere with the HDL-raising effect of niacin.
- •11.Renal insufficiency with serum creatinine >2,0mg%
- •12.Untreated hypothyroidism
- •13.Uncontrolled diabetes mellitus with fasting glucose >180mg% or hemoglobin A1c >9%.
- •14.Thrombocytopenia < 100Giga/l
- •15.Arterial hypotension (systolic blood pressure <90mmHg)
- •16.Myocardial infarction, PTCA or CABG within 3months
- •17.Need for coronary revascularization within next 6 months
- •18.Chronic obstructive pulmonary disease requiring medication
- •19.High-grade AV-block
- •20.Pregnant or nursing women
- •21.Any surgical or medical condition, which in the opinion of the investigator, may place the patient at higher risk form his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study
- •22.Participation in other clinical trial 30days before randomization
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