High Dose Candesartan Versus Quinapril for Restenosis Prophylaxis After Stent Angioplasty

NCT ID: NCT00154050

Last Updated: 2006-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-05-31

Study Completion Date

2006-07-31

Brief Summary

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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

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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.

Conditions

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Arterial Occlusive Diseases

Keywords

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restenosis intima hyperproliferation stent angioplasty pain-free walking distance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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candesartan (drug) or quinapril (drug)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Technische Universität Dresden

OTHER

Sponsor Role lead

Principal Investigators

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Wilhelm Kirch, MD

Role: STUDY_CHAIR

Institute of Clinical Pharmacology

Locations

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Chemnitz Hospital, Dept. of Internal Medicine I

Chemnitz, , Germany

Site Status

Countries

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Germany

Other Identifiers

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IKPD KARDCHEM 02-04

Identifier Type: -

Identifier Source: org_study_id