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

Sanofi

Status and phase: Completed; Phase 4

Conditions: Peripheral Arterial Disease

Treatments: Drug: Clopidogrel (Plavix)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00648453

L_8564

Details and patient eligibility

About

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

Enrollment: 39 patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)