High Dose Candesartan Versus Quinapril for Restenosis Prophylaxis After Stent Angioplasty
Information source: Dresden University of Technology
Information obtained from ClinicalTrials.gov on June 20, 2008 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Arterial Occlusive Diseases
Intervention: candesartan (drug) or quinapril (drug) (Drug)
Phase: N/A
Status: Completed
Sponsored by: Dresden University of Technology Official(s) and/or principal investigator(s): Wilhelm Kirch, MD, Study Chair, Affiliation: Institute of Clinical Pharmacology
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.
Clinical Details
Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: Restenosis/reintervention after 6 months
Secondary outcome: pain-free walking distancecrurobrachial pressure ratios
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
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
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
Locations and Contacts
Chemnitz Hospital, Dept. of Internal Medicine I, Chemnitz 09313, Germany
Additional Information
Starting date: May 2004
Ending date: July 2006
Last updated: September 11, 2006
|