High Dose Candesartan Versus Quinapril for Restenosis Prophylaxis After Stent Angioplasty

Arterial Occlusive Diseases Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00154050
• Other study ID #: IKPD KARDCHEM 02-04
• Status: Completed
• Phase: N/A
• First received: September 8, 2005
• Last updated: September 11, 2006
• Start date: May 2004
• Est. completion date: July 2006

Study information

• Verified date: September 2006
• Source: Technische Universität Dresden
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arterial Occlusive Diseases

Intervention

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

Locations

Country	Name	City	State
Germany	Chemnitz Hospital, Dept. of Internal Medicine I	Chemnitz

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität Dresden

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Restenosis/reintervention after 6 months
Secondary	pain-free walking distance
Secondary	crurobrachial pressure ratios