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High Dose Candesartan Versus Quinapril for Restenosis Prophylaxis After Stent Angioplasty

Primary Purpose

Arterial Occlusive Diseases

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

candesartan (drug) or quinapril (drug)

About this trial

This is an interventional treatment trial for Arterial Occlusive Diseases focused on measuring restenosis, intima hyperproliferation, stent angioplasty, pain-free walking distance

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Chemnitz Hospital, Dept. of Internal Medicine I

Outcomes

Primary Outcome Measures

Restenosis/reintervention after 6 months

Secondary Outcome Measures

pain-free walking distance

crurobrachial pressure ratios

Full Information

NCT ID

NCT00154050

First Posted

September 8, 2005

Last Updated

September 11, 2006

Sponsor

Technische Universität Dresden

1. Study Identification

Unique Protocol Identification Number

NCT00154050

Brief Title

High Dose Candesartan Versus Quinapril for Restenosis Prophylaxis After Stent Angioplasty

Study Type

Interventional

2. Study Status

Record Verification Date

September 2006

Overall Recruitment Status

Completed

Study Start Date

May 2004 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

July 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Technische Universität Dresden

4. Oversight

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

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

Arterial Occlusive Diseases

Keywords

restenosis, intima hyperproliferation, stent angioplasty, pain-free walking distance

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

22 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

candesartan (drug) or quinapril (drug)

Primary Outcome Measure Information:

Title

Restenosis/reintervention after 6 months

Secondary Outcome Measure Information:

Title

pain-free walking distance

Title

crurobrachial pressure ratios

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wilhelm Kirch, MD

Organizational Affiliation

Institute of Clinical Pharmacology

Official's Role

Study Chair

Facility Information:

Facility Name

Chemnitz Hospital, Dept. of Internal Medicine I

City

Chemnitz

ZIP/Postal Code

09313

Country

Germany

12. IPD Sharing Statement

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High Dose Candesartan Versus Quinapril for Restenosis Prophylaxis After Stent Angioplasty

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