NCT00800800已完成3 期
Effect of Cholesterol Lowering on the Progression of Aortic Stenosis in Patients With Mild to Moderate Aortic Stenosis (ASTRONOMER)Aortic Stenosis Progression Observation Measuring Effects of Rosuvastatin and The Sub-Study Protocol.
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
- 378
- 试验地点
- 1
- 主要终点
- The changes in transvalvular aortic velocities and the changes in aortic valve area.
研究概览
简要总结
The purpose of this study is to assess the effects of rosuvastatin compared to usual care in patients diagnosed with aortic valvular stenosis. Patients must have a diagnosis of mild to moderate aortic stenosis (AS) and no clinical indication for the use of cholesterol lowering agents. A multi-centre, randomized, double-blind, placebo-controlled study, with a two year recruitment period, and a treatment duration of a minimum of 3 years from the time of the last patient randomized to a maximum of 5 years.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 82 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mild to moderate AS defined by peak Doppler aortic valve velocity 2.5 to 4 m/sec
- •Baseline LDL-C value must be within targeted level for all risk categories according to the Canadian Guidelines
- •Baseline triglyceride levels must be within target level for the risk categories
排除标准
- •Very mild AS defined by peak Doppler AS velocity <2.5m/sec, because the rate of progression is not well defined; Females of child bearing potential who do not practice adequate contraception.
- •Severe AS defined by peak Doppler AS velocity > 4m/sec. These patients are excluded because they will have a high probability of aortic valve replacement even without further AS progression.
- •Greater than moderate aortic regurgitation, defined as aortic jet width to aortic outflow tract ratio >0.45; Patients with diabetes or with a fasting blood sugar level > 7.0 mmol/L (must be confirmed with one repeat assay within 14 days).
- •Significant concomitant mitral valve disease, defined by > moderate mitral regurgitation (MR) or mitral valve area (MVA)< 1.5 cm2; A very high risk of CAD (10 year risk > 30%), according to the Canadian Guidelines.
研究组 & 干预措施
1
Active Comparator
Rosuvastatin 40 mg
干预措施: Rosuvastatin (Drug)
2
Placebo Comparator
placebo
干预措施: Placebo (Drug)
结局指标
主要结局
The changes in transvalvular aortic velocities and the changes in aortic valve area.
时间窗: Between baseline and close-out measurments.
次要结局
- The incidence and severity of adverse events, the clinically relevant changes in echocardiograms, and laboratory analysis will be compared between the two treatment groups.(Between baseline and close-out measurments.)
研究者
研究点 (1)
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