NCT01203982已完成4 期
Effect of Intensive Lipid Lowering Treatment Compared to Moderate Lipid Lowering Treatment on Carotid Intima Media Thickness and Its Relation to Plaque Components of the Coronary Arteries in Patients With ST-Segment Elevation Acute Myocardial Infarction
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
- change from baseline in mean CIMT
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 carotid intima-media thickness (CIMT) as a surrogate marker of cardiovascular risk.
详细描述
The aim of this study was to measure the effect of moderate (5mg) and intensive (40mg) lipid-lowering treatment with rosuvastatin on the carotid intima-media thickness as a surrogate marker of cardiovascular risk and to obtain whether CIMT correlated with the plaque components in coronary arteries evaluated with Intravascular Ultrasound Virtual Histology (IVUS-VH).
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 and
- •a non significant lesion in one of the two non-culprit coronary arteries. -
排除标准
- •age below 18 or above 81 years,
- •unconscious patients,
- •serum creatinine > 176μmol/L,
- •total-cholesterol > 7.0 mmol/l,
- •hypothyroidism ((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
Active Comparator
Rosuvastatin 5mg/day
干预措施: Rosuvastatin (Drug)
Rosuvastatin 40mg
Active Comparator
Rosuvastatin 40mg/day
干预措施: Rosuvastatin (Drug)
结局指标
主要结局
change from baseline in mean CIMT
时间窗: baseline, 6month, 12 month
Average of the far wall of common and bulbus carotid artery
次要结局
- changes from baseline in max CIMT(baseline, 6month, 12 month)
- change from baseline in mean common CIMT(baaseline, 6month 12 month)
- change from baseline in max common CIMT(baseline, 6month 12month)
- change from baseline in mean bulbus CIMT(Baseline, 6month 12 month)
- change from baseline in max bulbus CIMT(baseline, 6month 12month)
- change from baseline in lipid values(baseline, 6month 12month)
- correlation between CIMT measurements and lipid values(Baseline, 6month 12 month)
- correlation between CIMT measurements and plaque components evaluated by IVUS-VH(Baseline, 6month 12month)
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 Endothelial FunctionEndothelial DysfunctionAtherosclerosisNCT01223625Odense 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