Intensive Blood Pressure and LDL Lowering for Better Survival and Cardiovascular Outcome in Diabetic Patients With Coronary Artery Disease: Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 798
- 试验地点
- 4
- 主要终点
- composite endpoint
研究概览
简要总结
The purpose of this study is to determine whether intensive blood pressure and low density lipoprotein (LDL) cholesterol lowering could improve survival and cardiovascular outcome in Japanese diabetic patients with coronary artery disease and history of acute coronary syndrome.
详细描述
Prevalence of type 2 diabetes in Asia seems to be almost epidemic and establishment of preventive strategy against macrovascular as well as microvascular diseases are warranted because of higher cardiovascular risk in diabetic patients even without history of atherosclerotic cardiovascular diseases. Benefit of lowering low density lipoprotein (LDL) cholesterol down to 70 mg/ml in Caucasian patients with coronary artery disease (CAD) has been well established but not in Asian patients with lower risk of myocardial infarction and higher stroke risk. Intensive lowering blood pressure for cardiovascular outcome in diabetic patients and patients with CAD has been recommended in several guidelines without firm evidence. Risk and benefit of intensive blood pressure and LDL control should be evaluated in Japanese diabetic CAD patients by pragmatic randomized controlled trial.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetic patients with coronary artery disease and history of acute coronary syndrome
- •Patients whose blood pressure and LDL cholesterol levels are above values recommended by the current guideline
排除标准
- •Patients who have active malignant tumor
- •Patients who are on hemodialysis due to end stage kidney disease
- •Patients whom statins are contraindicated
- •Patients who had acute coronary syndrome or stroke within 3 months
- •Patients who are pregnant or on breast feeding
- •Patients whose physicians deem that attending this trial is contraindicated or inappropriate
结局指标
主要结局
composite endpoint
时间窗: 3 years
composite endpoint consisting of all-cause mortality, non-fatal myocardial infarction, non-fatal stroke and unstable angina requiring hospital administration
important secondary composite endpoint
时间窗: 3 years
composite endpoint consisting of all-cause mortality, non-fatal myocardial infarction, non-fatal stroke, unstable angina requiring hospital administration, and admission for heart failure
次要结局
- stroke(3 years)
- all-cause mortality(3 years)
- myocardial infarction(3 years)
- peripheral artery disease(3 years)
- Cardiovascular death(3 years)
- new onset or deterioration of heart failure(3 years)
- end stage renal disease(3 years)
研究者
Takeshi Morimoto
Professor
Kyoto University, Graduate School of Medicine