Zainidip in Renal Artery Stenosis

Lee's Pharmaceutical

Status and phase: Completed; Phase 4

Conditions: Hypertension

Treatments: Drug: Clopidogrel; Drug: Aspirine; Device: stent; Drug: Lercanidipine

Study type: Interventional

Funder types: Industry

Identifiers

NCT02594410

Zhaoke-1503-zanidip

Details and patient eligibility

About

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

Enrollment: 149 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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149 participants in 1 patient group

Treatment

Experimental group

Description:

patients receiving renal artery stenting and anti-hypertension drug for renal artery atherosclerosis

Treatment:

Drug: Clopidogrel

Device: stent

Drug: Lercanidipine

Drug: Aspirine