Compare Effects of Intensive Versus Conventional Lipid-lowering Therapy in Patients With Severe Atherosclerotic Renal Artery Stenosis Undergoing Stent Placement

Phase 2

Completed

• Conditions: Stents; Lipids; Blood Pressure; Glomerular Filtration Rate; Renal Artery Obstruction
• Interventions: Drug: Rosuvastatin

• Registration Number: NCT03521700
• Lead Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06-01
• Primary Completion: 2014-12-30
• Study Completion: 2015-12-30
• Study First Submitted: 2018-04-29
• Study First Submitted QC: 2018-04-29
• Status Verified: 2018-05
• Study First Posted: 2018-05-11
• Last Update Submitted: 2018-05-25
• Last Update Posted: 2018-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intensive lipid lowering group	Rosuvastatin	10 mg/d rosuvastatin was initially prescribed and target LDL-C was \< 1.8mmol/L
Conventional lipid lowering group	Rosuvastatin	5 mg/d rosuvastatin was initially prescribed and target LDL-C was ≥1.8mmol/L, \<3.3mmol/L

Primary Outcome Measures

Name	Time	Method
Change in estimated glomerular filtration rate	12 months after randomization

Secondary Outcome Measures

Name	Time	Method
Stent restenosis rate	12 months after randomization
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	death from cardiovascular or renal causes, myocardial infarction, hospitalization for congestive heart failure, stroke, and a relative increase in SCr from baseline of ≥50%
Change in diastolic blood pressure	12 months after randomization

Trial Locations

Locations (1)

Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College; 🇨🇳 Beijing, Beijing, China