Clinical trial NCT03521700: Compare Effects of Intensive Versus Conventional Lipid-lowering Therapy in Patients With Severe Atherosclerotic Renal Artery Stenosis Undergoing Stent Placement
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Renal Artery Obstruction
Stents
Lipids
Glomerular Filtration Rate
Blood Pressure
Keywords: Renal Artery Obstruction
Stents
Glomerular filtration rate
Lead sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor class: OTHER
First posted: 2018-05-11
Enrollment: 150
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intensive lipid lowering gourp:10 mg/d rosuvastatin was initially prescribed and target LDL-C was \< 1.8mmol/L; Conventional lipid lowering: 5 mg/d rosuvastatin was initially prescribed and target LDL-C was ≥1.8mmol/L, \<3.3mmol/L
Primary purpose: TREATMENT

Brief summary: 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)


Eligibility criteria: Inclusion Criteria:

1. 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;
2. 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);
3. Estimated glomerular filtration rate≥ 10 ml/min/1.73m2 with longitudinal kidney length ≥ 7 cm supplied by target artery;
4. Serum creatinine level\<264umol/L；
5. Urine protein≤ 1+

Exclusion Criteria:

1. Allergy to rosuvastatin;
2. Myopathy;
3. Active liver disease or alanine aminotransferase and/or aspartate aminotransferase levels ≥ three times the upper limit of normality;
4. Serious perioperative complications;
5. Severe chronic congestive heart failure (New York Heart Association functional class IV );
6. Patients who should be excluded basing on physician discretion.

Primary outcomes:
measure: Change in estimated glomerular filtration rate
timeFrame: 12 months after randomization
Secondary outcomes:
measure: Change in urinary albumin-creatinine ratio
timeFrame: 12 months after randomization
measure: Change in the number of antihypertensive medications
timeFrame: 12 months after randomization
measure: Change in systolic blood pressure
timeFrame: 12 months after randomization
measure: Change in diastolic blood pressure
timeFrame: 12 months after randomization
measure: Stent restenosis rate
timeFrame: 12 months after randomization
measure: Major clinical events
timeFrame: 12 months after randomization
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College
state: Beijing
Study officials:
affiliation: Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College
name: Xiongjing Jiang, MD
role: PRINCIPAL_INVESTIGATOR
References: