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

Verified by: Sanofi-Aventis, April 2008
First Received: March 28, 2008 | Last Updated: April 1, 2008 | Phase: Phase 4 | Start Date: December 2002
Overall Status: Completed | Estimated Enrollment: 39
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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...

Brief Summary

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”

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

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

Intervention(s) in this Clinical Trial

  • Drug: Clopidogrel (Plavix)

Outcome Measures for this Clinical Trial

Primary Measures

  • Change of the laser Doppler parameters measured after three months clopidogrel /75 mg/day/ treatment compared to the pre-treatment values.
    • Time Frame: 3 months

Secondary Measures

  • Safety of clopidogrel /75 mg/day/ treatment
    • Time Frame: 3 months

Criteria for Participation in this Clinical Trial

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 30 Years

Maximum Age for this Clinical Trial: 70 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Sanofi-Aventis Industry

Overall Clinical Trial Officials and Contacts

Laszlo Eros Study Director Sanofi-Aventis  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00648453

Study ID Number: L_8564

ClinicalTrials.gov Identifier: NCT00648453

Health Authority: Hungary: Orszagos Gyogyszereszeti Intezet

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