Primary Prevention of Cardiovascular Disease in Pre-diabetic & Pre-hypertensive Subjects Using Multiple Risks Reduction Strategy: A Multi-center, Double-blind, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 8,900
- 试验地点
- 1
- 主要终点
- Cardiovascular Events
研究概览
简要总结
The purpose of this study is to determine whether treating pre-diabetic & pre-hypertensive individuals using multiple drugs intervention (anti-hypertensive drugs (i.e., ACEI) plus anti-glycemic drug (i.e., metformin) plus anti-hyperlipidemic drug (statin)) would lower Cardiovascular Disease (CVD) events.
详细描述
The risks of CVD are not confined to a subset of established "hypertensive" or "diabetic" population, but also increase among those with suboptimal blood pressure and glycemic level, namely "pre-hypertensive" or "pre-diabetic" population. Evidence on the effectiveness of drug interventions to lower CVD events in pre-clinical stage population has been scant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Pre-diabetes
- •Pre-hypertensives
- •LDL-Cholesterol >= 100 < 190 mg/dl
- •BMI >= 23
- •Estimated GFR >= 60 ml/min/1.73 m2 (MDRD equation)
- •Willing to participate and provide written inform consent
排除标准
- •Current involved in other studied medications
- •Regular use of corticosteroids
- •Current use of weight loss medication
- •History of renal disease
- •Active liver disease including jaundice, chronic hepatitis with ALT >= 2.5 the upper normal limit
- •Active malignancy
- •Major psychiatric disorder
- •Diseases and medications that affect glucose tolerance (e.g. pheochromocytoma, Cushing's syndrome, acromegaly, steroid-dependent asthma, protease inhibitors, antipsychotics)
- •Nursing women, pregnant women, or those that plan to become pregnant in the study period
研究组 & 干预措施
Metformin+Enalapril+Simvastatin
干预措施: Metformin+Enalapril+Simvastatin (Drug)
Placebo tablet
干预措施: Placebo tablet (Drug)
结局指标
主要结局
Cardiovascular Events
时间窗: 4-year
Fatal or Non-fatal Myocardial Infarction, Angina Pectoris, Congestive Heart Failure, Coronary Revascularization, Fatal or Non-fatal Stroke, Amputation of Lower Extremities (non-traumatic cause)
次要结局
- Micro-vascular Complications(4-year)
- Cumulative Incidence of Diabetes(4-year)
- Cumulative Incidence of Hypertension(4-year)
- Incidence of Individual Cardiovascular Disease(4-year)