Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Bristol-Myers Squibb
Information provided by:
Sanofi Identifier:
First received: March 28, 2008
Last updated: April 1, 2008
Last verified: April 2008

March 28, 2008
April 1, 2008
December 2002
Not Provided
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 ]
Same as current
Complete list of historical versions of study NCT00648453 on Archive Site
Safety of clopidogrel /75 mg/day/ treatment [ Time Frame: 3 months ]
Same as current
Not Provided
Not Provided
Effect of Plavix on NO (Nitrogen Monoxide) Production of the Endothelial Function
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
Not Provided
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Peripheral Arterial Disease
Drug: Clopidogrel (Plavix)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
April 2004
Not Provided

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.

30 Years to 70 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Not Provided
Study Director, sanofi-aventis
Bristol-Myers Squibb
Study Director: Laszlo Eros Sanofi
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP