Effect of Plavix on NO (Nitrogen Monoxide) Production of the Endothelial Function
Information source: Sanofi-Aventis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Peripheral Arterial Disease
Intervention: Clopidogrel (Plavix) (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Sanofi-Aventis Official(s) and/or principal investigator(s):
Laszlo Eros, Study Director, Affiliation: Sanofi-Aventis
Summary
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
Clinical Details
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
Study design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Change of the laser Doppler parameters measured after three months clopidogrel /75 mg/day/ treatment compared to the pre-treatment values.
Secondary outcome: Safety of clopidogrel /75 mg/day/ treatment
Eligibility
Minimum age: 30 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Sanofi-Aventis, Budapest, Hungary
Additional Information
clinicalstudyresults.org
Starting date: December 2002
Ending date: April 2004
Last updated: April 1, 2008
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