High Dose Candesartan Versus Quinapril for Restenosis Prophylaxis After Stent Angioplasty

This study has been completed.

First Received: September 8, 2005 Last Updated: September 11, 2006 History of Changes

Sponsor:	Dresden University of Technology
Information provided by:	Dresden University of Technology
ClinicalTrials.gov Identifier:	NCT00154050

Purpose

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.

Condition	Intervention
Arterial Occlusive Diseases	Drug: candesartan (drug) or quinapril (drug)

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

Resource links provided by NLM:

MedlinePlus related topics: Angioplasty

Drug Information available for: Quinapril hydrochloride Quinapril CV 11974 Candesartan cilexetil

U.S. FDA Resources

Further study details as provided by Dresden University of Technology:

Primary Outcome Measures:

Restenosis/reintervention after 6 months

Secondary Outcome Measures:

pain-free walking distance
crurobrachial pressure ratios

Estimated Enrollment:	22
Study Start Date:	May 2004
Estimated Study Completion Date:	July 2006

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.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00154050

Locations

Germany
Chemnitz Hospital, Dept. of Internal Medicine I
Chemnitz, Germany, 09313

Sponsors and Collaborators

Dresden University of Technology

Investigators

Study Chair:

Wilhelm Kirch, MD

Institute of Clinical Pharmacology

More Information

No publications provided

Study ID Numbers:	IKPD KARDCHEM 02-04
Study First Received:	September 8, 2005
Last Updated:	September 11, 2006
ClinicalTrials.gov Identifier:	NCT00154050 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Dresden University of Technology:

restenosis
intima hyperproliferation
stent angioplasty
pain-free walking distance

Additional relevant MeSH terms:

Arterial Occlusive Diseases
Quinapril
Molecular Mechanisms of Pharmacological Action
Vascular Diseases
Enzyme Inhibitors
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

Protease Inhibitors
Angiotensin II Type 1 Receptor Blockers
Candesartan cilexetil
Therapeutic Uses
Candesartan
Angiotensin-Converting Enzyme Inhibitors
Cardiovascular Diseases

ClinicalTrials.gov processed this record on February 08, 2010