Effect of Plavix on NO (Nitrogen Monoxide) Production of the Endothelial Function

• Status: Completed
• Trial end date: 2004-04-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Collaborator: Bristol-Myers Squibb
• Treatments: Clopidogrel

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.