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

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

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)

Study Overview

• Status: Completed
• Conditions: Blood Pressure; Renal Artery Obstruction; Glomerular Filtration Rate; Stents; Lipids
• Intervention / Treatment: Drug: Rosuvastatin

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 010
      • Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in estimated glomerular filtration rate	12 months after randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	death from cardiovascular or renal causes, myocardial infarction, hospitalization for congestive heart failure, stroke, and a relative increase in SCr from baseline of ≥50%	12 months after randomization

Collaborators and Investigators

• Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2013
• Primary Completion (ACTUAL): December 30, 2014
• Study Completion (ACTUAL): December 30, 2015

Study Registration Dates

• First Submitted: April 29, 2018
• First Submitted That Met QC Criteria: April 29, 2018
• First Posted (ACTUAL): May 11, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 29, 2018
• Last Update Submitted That Met QC Criteria: May 25, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Stents; Glomerular filtration rate; Renal Artery Obstruction
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arterial Occlusive Diseases; Kidney Diseases; Urologic Diseases; Renal Artery Obstruction; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Rosuvastatin Calcium
• Other Study ID Numbers: 2014-ZX13

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No