The Study of Atherosclerosis With Ramipril and Rosiglitazone
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,200
- 主要终点
- The change of the mean maximum carotid intimal medial thickness (IMT)evaluated across 12 segments involving the left and right common carotid, bifurcation and internal carotid arteries.
研究概览
简要总结
The purpose of this study is to determine if ramipril and/or rosiglitazone retard the progression of atherosclerosis as evaluated by serial carotid intermedial thickness measurements.
详细描述
STARR is a multi-centre, international, randomized controlled clinical trial with a 2x2 factorial design, that will evaluate the effects of ramipril and of rosiglitazone on atherosclerosis progression, as determined by B-mode carotid ultrasound (US). It is designed as a substudy of DREAM (Diabetes Reduction Assessment with ramipril and rosiglitazone Medications) Trial. The study is designed to enroll 1,200 study participants and follow is proposed for an average of 3.75 years.
SIGNIFICANCE OF THE PROPOSED RESEARCH: With regards to ramipril this study will provide important mechanistic data regarding potential benefits of ACE inhibitor therapy on atherosclerosis and by inference in reducing CV risk in a lower risk younger population than studied in previous trials. In this population a clinical outcome trial focusing primarily on CV events would be difficult to conduct due to the expected fairly low event rate. If the study on atherosclerosis is positive, this may provide a rational for therapy in this subset of patients without overt CVD or diabetes, but with impaired glucose tolerance or impaired fasting glucose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Double
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •impaired glucose tolerance (FPG < 7 mmol/L or 126 mg/dL & 2hr PG between 7.8-11.0 mmol/l [140-199 mg/dl] after a 75 g OGTT
- •impaired glucose tolerance (FPG≥ 6.1 mmol/l [110 mg/dl]) and no diabetes (i.e. a FPG < 7.0 mmol/l [126 mg/dl])
- •a technically adequate baseline carotid ultrasound examination
排除标准
- •current use of an ACE-inhibitor (ACE-I) or thiazolidinedione (TZD)
- •known hypersensitivity to ACE-I
- •prior use of anti-diabetic medications 9with the exception of during pregnancy)
- •use of systemic glucocorticoids or niacin
- •congestive heart failure or EF < 40%
- •existing cardiovascular disease (previous MI, stroke, angina, uncontrolled hypertension)
- •renal or hepatic disease
- •major illness
- •use of another experimental drug
- •pregnant or unwilling to use reliable contraception
- •major psychiatric disorder
- •diseases that affect glucose tolerance
- •unwillingness to be randomized or sign informed consent
- •known uncontrolled substance abuse
- •inability to communicate with research staff
结局指标
主要结局
The change of the mean maximum carotid intimal medial thickness (IMT)evaluated across 12 segments involving the left and right common carotid, bifurcation and internal carotid arteries.
次要结局
- The change over time in the mean IMT across the common carotid far wall IMT of the right and the left carotid arteries.