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NCT00648453 Clinical Trial

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

Peripheral Arterial Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00648453
Other study ID # L_8564
Secondary ID
Status Completed
Phase Phase 4
First received March 28, 2008
Last updated April 1, 2008
Start date December 2002
Est. completion date April 2004

Study information
Verified date April 2008
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority Hungary: Orszagos Gyogyszereszeti Intezet
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 39
Est. completion date April 2004
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 30 Years to 70 Years
Eligibility 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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Clopidogrel (Plavix)

Locations
Country Name City State
Hungary Sanofi-Aventis Budapest

Sponsors (2)
Lead Sponsor Collaborator
Sanofi Bristol-Myers Squibb

Country where clinical trial is conducted

Hungary, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change of the laser Doppler parameters measured after three months clopidogrel /75 mg/day/ treatment compared to the pre-treatment values. 3 months
Secondary Safety of clopidogrel /75 mg/day/ treatment 3 months
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