To determine whether in the laser Doppler flowmetric parameters characteristic of endothelial dysfunction at patients with clinically manifest atherosclerosis any change can be detected at plavix (clopidogrel) treatment. Laser Doppler /LD/ measurement combined with iontophoresis evaluates the effect of acetylcholine /ACh/ /endothelium dependent/ and sodium nitroprusside /NSP/ /endothelium...
Date First Received: March 28, 2008
Last Updated: April 1, 2008
Verified by: Sanofi-Aventis, April 2008
Clinical Trial Phase: Phase 4 | Start Date: December 2002
Overall Status: Completed
Estimated Enrollment: 39
Brief Summary
Official Title: “Effect of Plavix Treatment on NO Production Measured by Laser Doppler Method Referring to Endothelial Function in Patients With Severe Coronary Heart Disease”
Condition Keyword(s):
Intervention(s):
To determine whether in the laser Doppler flowmetric parameters characteristic of endothelial dysfunction at patients with clinically manifest atherosclerosis any change can be detected at plavix (clopidogrel) treatment. Laser Doppler /LD/ measurement combined with iontophoresis evaluates the effect of acetylcholine /ACh/ /endothelium dependent/ and sodium nitroprusside /NSP/ /endothelium independent/ on the microcirculation of the skin
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: Clopidogrel (Plavix)
Outcome Measures for this Clinical Trial
Primary Measures
- Change of the laser Doppler parameters measured after three months clopidogrel /75 mg/day/ treatment compared to the pre-treatment values.
- Time Frame: 3 months
- Time Frame: 3 months
Secondary Measures
- Safety of clopidogrel /75 mg/day/ treatment
- Time Frame: 3 months
- Time Frame: 3 months
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Proven, peripheral arterial disease, Fontain II-III stage, patient submitted to secondary prophylactic thrombocyte aggregation inhibiting treatment
- Doppler index < 0,8
Exclusion Criteria:
- Hypersensitivity to the active ingredient or one of the components of the drug
- Active pathological bleeding, e.g. gastric ulcer, intracranial bleeding
- Pregnancy, breast-feeding
- Severe, known hepatic insufficiency
- Severe, known renal insufficiency
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 30 Years
Maximum Age for this Clinical Trial: 70 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Sanofi-Aventis
Overall Clinical Trial Officials and Contacts
Laszlo Eros Study Director Sanofi-Aventis
Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00648453
Study ID Number: L_8564
ClinicalTrials.gov Identifier: NCT00648453
Health Authority: Hungary: Orszagos Gyogyszereszeti Intezet
Clinical Trials Authorship and Review
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