The study is designed to test the hypothesis that high dose candesartan treatment compared to quinapril is able to reduce intima hyperproliferation and the restenosis rate after stent angioplasty in peripheral occlusive artery disease.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study

Patients are randomly assigned to treatment with either candesartan 32 mg/d or Quinapril 20 mg/d before the angioplasty. Walking distance, intima media thickness and crurobrachial pressure ratios are compared after 6 weeks, 3 months and 6 months. After 6 months an angiographic control is performed.

Intervention(s) in this Clinical Trial

• Drug: candesartan (drug) or quinapril (drug)

Primary Measures

• Restenosis/reintervention after 6 months

Secondary Measures

• pain-free walking distance
• crurobrachial pressure ratios

Inclusion Criteria:

• male and female
• peripheral occlusive arterial disease Stad IIb Fontaine classification

Exclusion Criteria:

• patients with lesions not available for PTA
• renal insufficiency
• patients on calcium-antagonists

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Dresden University of Technology

Overall Clinical Trial Officials and Contacts

Wilhelm Kirch, MD Study Chair Institute of Clinical Pharmacology  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00154050

Study ID Number: IKPD KARDCHEM 02-04

ClinicalTrials.gov Identifier: NCT00154050

Health Authority: Germany: Federal Institute for Drugs and Medical Devices