Zainidip in Renal Artery Stenosis

Phase 4

Completed

• Conditions: Hypertension
• Interventions: Device: stent; Drug: Aspirine; Drug: Clopidogrel; Drug: Lercanidipine

• Registration Number: NCT02594410
• Lead Sponsor: Lee's Pharmaceutical Limited

Brief Summary

To evaluate the efficacy of renal artery stent combined with standardized medical therapy as treatment for renal artery stenosis.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Primary Completion: 2014-03
• Study Completion: 2014-05
• Status Verified: 2015-10
• Study First Submitted: 2015-10-29
• Study First Submitted QC: 2015-10-30
• Last Update Submitted: 2015-10-30
• Study First Posted: 2015-11-03
• Last Update Posted: 2015-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 149

Inclusion Criteria

• Age between 40 - 75
• Diameter of stenosis of renal artery or main branch of renal artery ≥60％. If diameter of stenosis is 60% - 75%, pressure difference between proximal and distal end ≥20 mm Hg (1mmHg=0.133kPa) or Captopril renography positive;
• Systolic blood pressure before taking antihypertensive ≥180mmHg and/or diastolic blood pressure ≥110 mmHg; taking three antihypertensive including one diuretics with systolic blood pressure ≥140mmHg and/or ≥90 mmHg;
• length of ipsilateral kidney is greater than 7.0cm.

Exclusion Criteria

• Estimated glomerular filtration rate (eGFR) <30 ml/ (min﹒1.73 m 2) [eGFR (mL/min/1.73 m2) = 186.3 * serum creatinine (mg/dl) -1.154 * Age-0.203 * 0.742 (female)[11];
• unstable condition and unable to tolerate interventional therapy;
• anatomy of renal artery pathology not suitable for interventional therapy;
• allergic to dihydropyridines;
• III degree atrioventricular block
• contrast allergy ;
• any known malignant tumor;
• non-compliant, history of alcoholism or drug abuse.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Lercanidipine	patients receiving renal artery stenting and anti-hypertension drug for renal artery atherosclerosis
Treatment	Aspirine	patients receiving renal artery stenting and anti-hypertension drug for renal artery atherosclerosis
Treatment	Clopidogrel	patients receiving renal artery stenting and anti-hypertension drug for renal artery atherosclerosis
Treatment	stent	patients receiving renal artery stenting and anti-hypertension drug for renal artery atherosclerosis

Primary Outcome Measures

Name	Time	Method
Glomerular filtration rate	12 months
Blood pressure	12 months

Trial Locations

Locations (1)

Fuwai Hospital; 🇨🇳 Beijing, China