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

Sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03521700

Collaborator

(none)

150

Enrollment

Location

Arms

30.9

Actual Duration (Months)

4.8

Patients Per Site Per Month

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Renal Artery Obstruction Stents Lipids Glomerular Filtration Rate Blood Pressure	Drug: Rosuvastatin	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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/LIntensive 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

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jun 1, 2013

Actual Primary Completion Date :

Dec 30, 2014

Actual Study Completion Date :

Dec 30, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intensive lipid lowering group 10 mg/d rosuvastatin was initially prescribed and target LDL-C was < 1.8mmol/L	Drug: Rosuvastatin For patients who were assigned to receive intensive lipid lowering, 10 mg/d rosuvastatin was initially prescribed and target LDL-C was < 1.8mmol/L. For patients who were assigned to receive conventional lipid lowering, 5 mg/d rosuvastatin was initially prescribed and target LDL-C was ≥1.8mmol/L, <3.3mmol/L.
Other: Conventional lipid lowering group 5 mg/d rosuvastatin was initially prescribed and target LDL-C was ≥1.8mmol/L, <3.3mmol/L	Drug: Rosuvastatin For patients who were assigned to receive intensive lipid lowering, 10 mg/d rosuvastatin was initially prescribed and target LDL-C was < 1.8mmol/L. For patients who were assigned to receive conventional lipid lowering, 5 mg/d rosuvastatin was initially prescribed and target LDL-C was ≥1.8mmol/L, <3.3mmol/L.

Arm

Intervention/Treatment

Experimental: Intensive lipid lowering group

10 mg/d rosuvastatin was initially prescribed and target LDL-C was < 1.8mmol/L

Drug: Rosuvastatin

For patients who were assigned to receive intensive lipid lowering, 10 mg/d rosuvastatin was initially prescribed and target LDL-C was < 1.8mmol/L. For patients who were assigned to receive conventional lipid lowering, 5 mg/d rosuvastatin was initially prescribed and target LDL-C was ≥1.8mmol/L, <3.3mmol/L.

Other: Conventional lipid lowering group

5 mg/d rosuvastatin was initially prescribed and target LDL-C was ≥1.8mmol/L, <3.3mmol/L

Drug: Rosuvastatin

Outcome Measures

Primary Outcome Measures

Change in estimated glomerular filtration rate [12 months after randomization]

Secondary Outcome Measures

Change in urinary albumin-creatinine ratio [12 months after randomization]
Change in the number of antihypertensive medications [12 months after randomization]
Change in systolic blood pressure [12 months after randomization]
Change in diastolic blood pressure [12 months after randomization]
Stent restenosis rate [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%

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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;
Serious perioperative complications;
Severe chronic congestive heart failure (New York Heart Association functional class IV );
Patients who should be excluded basing on physician discretion.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College	Beijing	Beijing	China	010

Sponsors and Collaborators

Chinese Academy of Medical Sciences, Fuwai Hospital

Investigators

Principal Investigator: Xiongjing Jiang, MD, Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College