NCT00620542已完成3 期
Study of Coronary Atheroma by Intravascular Ultrasound: Effect of Rosuvastatin Versus Atorvastatin (SATURN)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 2,333
- 试验地点
- 1
- 主要终点
- Change From Baseline to End of Study (Week 104) in Percent Atheroma Volume (PAV)
研究概览
简要总结
A 104-week, randomized, double-blind, parallel group, multi-center Phase IIIb study comparing the effects of treatment with rosuvastatin 40 mg or atorvastatin 80 mg on atherosclerotic disease burden as measured by intravascular ultrasound in patients with coronary artery disease.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical indication for coronary angiography
- •Angiographic evidence of Coronary Artery Disease (CAD), as defined by at least 1 lesion in a native coronary artery that has >20% reduction in lumen diameter by visual estimation
- •Left main coronary artery must have <=50% reduction in lumen diameter by visual estimation
- •LDL-C >100 mg/dL (2.6 mmol/L) for patients with no statin therapy in the past 4 weeks; LDL-C >80mg/dL (2.08mmol/L) for patients on therapy in the past 4 weeks
排除标准
- •Use of certain lipid-lowering medication for more than 3 months within the previous 12 months. Longer periods of treatment are not permitted because of the potential effects of such therapy on coronary atherosclerosis.
- •Patients who have symptoms consistent with moderate or greater severity of Congestive Heart Failure (CHF).
- •Clinically significant heart disease which, in the opinion of the Principal Investigator (or designee), is likely to require coronary bypass surgery, cardiac transplantation, surgical repair and/or replacement during the course of the study
研究组 & 干预措施
Rosuvastatin 20 mg
Experimental
Rosuvastatin 20 mg distributed in 2-week run-in period
干预措施: Rosuvastatin (Drug)
Atorvastatin 40 mg
Active Comparator
Atorvastatin 40 mg distributed in 2-week run-in period
干预措施: Atorvastatin (Drug)
Rosuvastatin 40 mg
Experimental
Rosuvastatin 40 mg distributed in core 2-year study
干预措施: Rosuvastatin (Drug)
Atorvastatin 80 mg
Active Comparator
Atorvastatin 80 mg distributed in core 2-year study
干预措施: Atorvastatin (Drug)
结局指标
主要结局
Change From Baseline to End of Study (Week 104) in Percent Atheroma Volume (PAV)
时间窗: End of study (Week 104)
Change in PAV computed as PAV(Week 104)-PAV(baseline) where PAV is calculated as: \[sum(EEMcsa-LUMENcsa)/sum EEMcsa\]\*100 where EEMcsa is the cross-sectional area of the external elastic membrane and LUMENcsa is the cross-sectional area of the lumen, as measured by intravascular ultrasound IVUS of a coronary artery in patients with CAD.
次要结局
- Numbers of Patients Showing Regression in PAV(End of study (Week 104))
- Change From Baseline to End of Study (Week 104) in Total Atheroma Volume (TAV)(End of study (Week 104))
- Numbers of Patients Showing Regression in TAV(End of study (Week 104))
- Total Cholesterol Blood Level(104 weeks)
- LDL-C Blood Level(104 weeks)
- HDL-C Blood Level(104 weeks)
- Triglycerides Blood Level(104 weeks)
- Non-HDL-C Blood Level(104 weeks)
- LDL-C/HDL-C Blood Level(104 weeks)
- Total Cholesterol/HDL-C Blood Level(104 weeks)
- Non-HDL-C/HDL-C Blood Level(104 weeks)
- Apolipoprotein B Blood Level(104 weeks)
- Apolipoprotein A-1 Blood Level(104 weeks)
- Apoliprotein B/Apolipoprotein A-1 Blood Level(104 weeks)
- VLDL-C During the 104 Week Treatment Period(104 weeks)
研究者
研究点 (1)
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