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

• ClinicalTrials.gov Identifier: NCT03521700
• Recruitment Status: Completed
• First Posted: May 11, 2018
• Last Update Posted: May 29, 2018
• Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
• Information provided by (Responsible Party): Xiongjing Jiang, Chinese Academy of Medical Sciences, Fuwai Hospital

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 (Clinical Trial)
• 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/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: June 1, 2013
• Actual Primary Completion Date: December 30, 2014
• Actual Study Completion Date: December 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.
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.

Outcome Measures

Primary Outcome Measures :

1. Change in estimated glomerular filtration rate [ Time Frame: 12 months after randomization ]

Secondary Outcome Measures :

1. Change in urinary albumin-creatinine ratio [ Time Frame: 12 months after randomization ]
2. Change in the number of antihypertensive medications [ Time Frame: 12 months after randomization ]
3. Change in systolic blood pressure [ Time Frame: 12 months after randomization ]
4. Change in diastolic blood pressure [ Time Frame: 12 months after randomization ]
5. Stent restenosis rate [ Time Frame: 12 months after randomization ]
6. Major clinical events [ Time Frame: 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

• Ages Eligible for Study: 40 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

China, Beijing

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

More Information

• Responsible Party: Xiongjing Jiang, Professor, Chinese Academy of Medical Sciences, Fuwai Hospital
• ClinicalTrials.gov Identifier: NCT03521700
• Other Study ID Numbers: 2014-ZX13
• First Posted: May 11, 2018
• Last Update Posted: May 29, 2018
• Last Verified: May 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Xiongjing Jiang, Chinese Academy of Medical Sciences, Fuwai Hospital:

Renal Artery Obstruction; Stents; Glomerular filtration rate

Additional relevant MeSH terms:

Renal Artery Obstruction; Kidney Diseases; Urologic Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Rosuvastatin Calcium; Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Enzyme Inhibitors