NCT01223625已完成4 期
Effect of Intensive Lipid Lowering Treatment Compared to Moderate Lipid Lowering Treatment on Endothelial Function
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- The change from baseline in endothelium-dependent flow mediated vasodilatation of the brachial artery.
研究概览
简要总结
The aim of this study was to measure the effect of moderate and intensive lipid-lowering treatment with rosuvastatin on the endothelial function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 81 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •no prior treatment with statins
排除标准
- •age below 18 or above 81 years
- •unconscious patients
- •serum creatinine > 176μmol/L
- •total-cholesterol > 7.0 mmol/l
- •hypothyreoidism ((TSH > 1.5 x ULN (upper limit of normal))
- •current liver disease (ALAT > 2 x ULN)
- •unexplained creatine kinase > 3 x ULN
- •alcohol or drug abuse within the last five years
- •prior myopathy or serious hypersensitivity reaction caused by statins
- •women with childbearing potential who were not using chemical or mechanical contraception
- •pregnant or breastfeeding women
- •history of malignancy unless a disease-free period of more than five years was present
- •patients with abnormal lung function test (LFT)
- •participation in another investigational drug study less than four weeks before enrolment in the present study
- •treatment with cyclosporine or fibrates.
研究组 & 干预措施
Rosuvastatin 5mg/day
Active Comparator
Rosuvastatin 5mg/day
干预措施: Rosuvastatin 5mg/day (Drug)
Rosuvastatin 40mg/day
Active Comparator
Rosuvastatin 40mg/day
干预措施: Rosuvastatin 40mg/day (Drug)
结局指标
主要结局
The change from baseline in endothelium-dependent flow mediated vasodilatation of the brachial artery.
时间窗: One year
次要结局
- The change from baseline in endothelium independent flow mediated vasodilatation of the brachial artery(One Year)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
4 期
Effect of Intensive Lipid Lowering Treatment Compared to Moderate Lipid Lowering Treatment on Carotid Intima-media Thickness (CIMT)ST-segment Elevation Myocardial InfarctionSubclinical Carotid AtherosclerosisNCT01203982Odense University Hospital87
已完成
4 期
Influence of Intensive Lipid Lowering Treatment Compared to Moderate Lipid Lowering TreatmentMyocardial Infarction [C14.907.585.500]NCT01245894Odense University Hospital87
招募中
4 期
Impact of Evolocumab as an Additional Lipid-lowering Therapy to Changes in Lipid Core Burden Index of Non-culprit Vulnerable Plaque in Patients Who Underwent Percutaneous Coronary Intervention for the Acute Coronary SyndromeClinical TrialAcute Coronary SyndromeNCT04719221Korea University Anam Hospital60
已完成
4 期
Lipitor Phase 4 Clinical Trial in Hypercholesteremia Patients With Yellow Coronary PlaqueHypercholesteremiaCoronary Artery DiseaseNCT00408382Astellas Pharma Inc50
已完成
4 期
Early Effects of Intensive Lipid Lowering Treatment With Ezetimibe/ Simvastatin (Vytorin®) Assessed by Virtual Histology-Intravascular Ultrasound (VH-IVUS) and Optical Coherence Tomography (OCT) on Plaque Characteristics in Patients With Acute Coronary SyndromeAcute Coronary SyndromeNCT01857843Yonsei University160