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

NCT03521700 | Completed Phase 2

• 1 other identifier: 2014-ZX13
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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)

Conditions

Renal Artery Obstruction; Stents; Lipids; Glomerular Filtration Rate; Blood Pressure

Keywords

Renal Artery Obstruction; Stents; Glomerular filtration rate

Outcome Measures

Primary Outcomes (1)

• Change in estimated glomerular filtration rate

  12 months after randomization

Secondary Outcomes (6)

• 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

Study Arms (2)

Intensive lipid lowering group

EXPERIMENTAL

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

Drug: Rosuvastatin

Conventional lipid lowering group

OTHER

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

Drug: Rosuvastatin

Interventions

Rosuvastatin DRUG

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.

Conventional lipid lowering group; Intensive lipid lowering group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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+

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese Academy of Medical Sciences, Fuwai Hospital: lead

Study Sites (1)

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

Beijing, Beijing Municipality, 010, China

Location

MeSH Terms

Conditions

Renal Artery Obstruction

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Xiongjing Jiang, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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

Study Record Dates

• First Submitted: April 29, 2018
• First Posted: May 11, 2018
• Study Start: June 1, 2013
• Primary Completion: December 30, 2014
• Study Completion: December 30, 2015
• Last Updated: May 29, 2018

Record last verified: 2018-05

Locations

CN (1)