Effect of Intensive Blood Pressure Control on Progression of Coronary Atherosclerosis: Randomized Evaluation by Intravascular Ultrasound
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- change of percent atheroma volume
研究概览
简要总结
The purpose of this study is to evaluate the effect of intensive blood pressure control compared to standard blood pressure control on progression of coronary atherosclerosis by intravascular ultrasound in hypertensive patients with coronary artery disease.
详细描述
Antihypertensive therapy is reported to reduce cardiovascular events in patients with coronary artery disease. The goal of blood pressure in patients with coronary artery disease is recommended to control below 140/90mmHg. However, the effect of intensive blood pressure control compared to standard blood pressure control is still unknown. The purpose of this study is to evaluate the effect of intensive blood pressure control compared to standard blood pressure control on progression of coronary atherosclerosis by intravascular ultrasound in hypertensive patients with coronary atherosclerosis after 18 months. The goal of systolic blood pressure is under 120mmHg in intensive blood pressure control group and under 140mmHg in standard blood pressure control group. The design of this study is randomized control study.
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
- None
入排标准
- 年龄范围
- 20 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •coronary artery diseases which require coronary angiography or percutaneous coronary intervention
- •primary hypertension (systolic blood pressure 140-180mmHg within one month)
排除标准
- •severe hypertension
- •secondary hypertension
- •treated with more than three antihypertensive drugs
- •left main trunk trunk coronary artery disease
- •moderate heart failure
- •severe valvular disease
- •liver dysfunction renal dysfunction (Cr>=2.0mg/dl) Pregnant or nursing women severe arrhythmia
研究组 & 干预措施
intensive blood pressure control
systolic blood pressure less than 120 mmHg
干预措施: control systolic blood pressure less than 120 mmHg (Drug)
standard blood pressure control
systolic blood pressure less than 140 mmHg
干预措施: control systolic blood pressure less than 140 mmHg (Drug)
结局指标
主要结局
change of percent atheroma volume
时间窗: 1.5-year
change of percent atheroma volume measured by intravascular ultrasound
次要结局
- all cause death(1.5-year)
- cardiac death(1.5-year)
- cardiovascular death(1.5-year)
- myocardial infarction(1.5-year)
- stroke(1.5-year)
- target-lesion revascularization(1.5-year)
- any coronary revascularization(1.5-year)
- hospitalization due to angina pectoris(1.5-year)
- hospitalization due to heart failure(1.5-year)
- change of total atheroma volume(1.5-year)
- percent change of total atheroma volume(1.5-year)
- change of atheroma volume at most severe 10mm lesion(1.5-year)
研究者
Takeshi Morimoto
Professor
Kyoto University, Graduate School of Medicine