Compare Effects of Intensive Versus Conventional Lipid-lowering Therapy in Patients With Severe A… (NCT03521700) | Clinical Trial Compass
CompletedPhase 2/3
Compare Effects of Intensive Versus Conventional Lipid-lowering Therapy in Patients With Severe Atherosclerotic Renal Artery Stenosis Undergoing Stent Placement
China150 participantsStarted 2013-06-01
Plain-language 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)
Who can participate
Age range40 Years – 80 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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+
Exclusion criteria
✕. Allergy to rosuvastatin;
✕. Myopathy;
✕. Active liver disease or alanine aminotransferase and/or aspartate aminotransferase levels ≥ three times the upper limit of normality;
✕
What they're measuring
1
Change in estimated glomerular filtration rate
Timeframe: 12 months after randomization
Trial details
NCT IDNCT03521700
SponsorChinese Academy of Medical Sciences, Fuwai Hospital