Effect of Plavix on NO (Nitrogen Monoxide) Production of the Endothelial Function
Phase 4
Completed
- Conditions
- Peripheral Arterial Disease
- Registration Number
- NCT00648453
- Lead Sponsor
- Sanofi
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 39
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Change of the laser Doppler parameters measured after three months clopidogrel /75 mg/day/ treatment compared to the pre-treatment values. 3 months
- Secondary Outcome Measures
Name Time Method Safety of clopidogrel /75 mg/day/ treatment 3 months
Trial Locations
- Locations (1)
Sanofi-Aventis
🇭🇺Budapest, Hungary