A Prospective, Randomized Trial to Compare Effects of Intensive Versus Conventional Lipid-lowering Therapy in Patients With Severe Atherosclerotic Renal Artery Stenosis Undergoing Stent Placement
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change in estimated glomerular filtration rate
研究概览
简要总结
Although expert consensuses recommend the use of statins in the treatment of atherosclerotic renal artery stenosis, in patients with severe atherosclerotic renal artery stenosis undergoing stent placement, the related investigation focused on renal protection by intensive lipid-lowering therapy is scant , and the optimal target level for lipid reduction remain uncertain. Therefore, we hypothesized that intensive lipid lowering could offer more benefits with respect to renal function in the patients with percutaneous renal artery stenting. We conducted the prospective randomized unblinded trial to compare the renal-protective effect of intensive lipid lowering with that of conventional lipid lowering in patients underwent renal artery stenting (75 patients in each study group)
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
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Angiographic evidence of severe atherosclerotic renal artery stenosis (diameter reduction≥ 70%) with ≥ 20 mmHg systolic translesional gradient or positive captopril renography in the target kidney;
- •Sustained systolic blood pressure ≥ 180 mmHg, and/or diastolic blood pressure ≥ 110 mmHg while not receiving drug therapy or systolic blood pressure ≥ 140 mmHg, and/or diastolic blood pressure ≥ 90mmHg while taking standard triple-drug combination treatment (including one diuretic);
- •Estimated glomerular filtration rate≥ 10 ml/min/1.73m2 with longitudinal kidney length ≥ 7 cm supplied by target artery;
- •Serum creatinine level<264umol/L；
- •Urine protein≤ 1+
排除标准
- •Allergy to rosuvastatin;
- •Active liver disease or alanine aminotransferase and/or aspartate aminotransferase levels ≥ three times the upper limit of normality;
- •Serious perioperative complications;
- •Severe chronic congestive heart failure (New York Heart Association functional class IV );
- •Patients who should be excluded basing on physician discretion.
研究组 & 干预措施
Intensive lipid lowering group
10 mg/d rosuvastatin was initially prescribed and target LDL-C was < 1.8mmol/L
干预措施: Rosuvastatin (Drug)
Conventional lipid lowering group
5 mg/d rosuvastatin was initially prescribed and target LDL-C was ≥1.8mmol/L, <3.3mmol/L
干预措施: Rosuvastatin (Drug)
结局指标
主要结局
Change in estimated glomerular filtration rate
时间窗: 12 months after randomization
次要结局
- Change in urinary albumin-creatinine ratio(12 months after randomization)
- Change in systolic blood pressure(12 months after randomization)
- Change in the number of antihypertensive medications(12 months after randomization)
- Major clinical events(12 months after randomization)
- Change in diastolic blood pressure(12 months after randomization)
- Stent restenosis rate(12 months after randomization)
研究者
Xiongjing Jiang
Professor
Chinese Academy of Medical Sciences, Fuwai Hospital