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

Primary Purpose

Renal Artery Obstruction, Stents, Lipids

Status

Completed

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Rosuvastatin

About this trial

This is an interventional treatment trial for Renal Artery Obstruction focused on measuring Renal Artery Obstruction, Stents, Glomerular filtration rate

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Intensive lipid lowering group

Conventional lipid lowering group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in estimated glomerular filtration rate

Secondary Outcome Measures

Change in urinary albumin-creatinine ratio

Change in the number of antihypertensive medications

Change in systolic blood pressure

Change in diastolic blood pressure

Stent restenosis rate

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%

Full Information

NCT ID

NCT03521700

First Posted

April 29, 2018

Last Updated

May 25, 2018

Sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03521700

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2018

Overall Recruitment Status

Completed

Study Start Date

June 1, 2013 (Actual)

Primary Completion Date

December 30, 2014 (Actual)

Study Completion Date

December 30, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Renal Artery Obstruction, Stents, Glomerular filtration rate

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

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)

Allocation

Randomized

Enrollment

150 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intensive lipid lowering group

Arm Type

Experimental

Arm Description

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

Arm Title

Conventional lipid lowering group

Arm Type

Other

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Rosuvastatin

Intervention Description

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 Measure Information:

Title

Change in estimated glomerular filtration rate

Time Frame

12 months after randomization

Secondary Outcome Measure Information:

Title

Change in urinary albumin-creatinine ratio

Time Frame

12 months after randomization

Title

Change in the number of antihypertensive medications

Time Frame

12 months after randomization

Title

Change in systolic blood pressure

Time Frame

12 months after randomization

Title

Change in diastolic blood pressure

Time Frame

12 months after randomization

Title

Stent restenosis rate

Time Frame

12 months after randomization

Title

Major clinical events

Description

death from cardiovascular or renal causes, myocardial infarction, hospitalization for congestive heart failure, stroke, and a relative increase in SCr from baseline of ≥50%

Time Frame

12 months after randomization

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xiongjing Jiang, MD

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Beijing

State/Province

Beijing

ZIP/Postal Code

010

Country

China

12. IPD Sharing Statement

Learn more about this trial

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

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