Peripheral Arterial Disease
Conditions
Keywords
Fontain II-III stage
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
Interventions
Sponsors
Bristol-Myers Squibb
Sanofi
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of the laser Doppler parameters measured after three months clopidogrel /75 mg/day/ treatment compared to the pre-treatment values. | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Safety of clopidogrel /75 mg/day/ treatment | 3 months |
Countries
Hungary
Outcome results
None listed