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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03521700
Recruitment Status : Completed
First Posted : May 11, 2018
Last Update Posted : May 29, 2018
Sponsor:
Information provided by (Responsible Party):
Xiongjing Jiang, 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)

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

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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

Resource links provided by the National Library of Medicine


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.




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%



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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03521700


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

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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    Key Record Dates
Last Update Posted: May 29, 2018
Last Verified: May 2018

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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:
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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