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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00648453
First Posted: April 1, 2008
Last Update Posted: April 3, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Bristol-Myers Squibb
Information provided by:
Sanofi
  Purpose
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

Condition Intervention Phase
Peripheral Arterial Disease Drug: Clopidogrel (Plavix) Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome 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 Outcome Measures:
  • Safety of clopidogrel /75 mg/day/ treatment [ Time Frame: 3 months ]

Enrollment: 39
Study Start Date: December 2002
Study Completion Date: April 2004
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   30 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00648453


Locations
Hungary
Sanofi-Aventis
Budapest, Hungary
Sponsors and Collaborators
Sanofi
Bristol-Myers Squibb
Investigators
Study Director: Laszlo Eros Sanofi
  More Information

Responsible Party: Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00648453     History of Changes
Other Study ID Numbers: L_8564
First Submitted: March 28, 2008
First Posted: April 1, 2008
Last Update Posted: April 3, 2008
Last Verified: April 2008

Keywords provided by Sanofi:
Fontain II-III stage

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Clopidogrel
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs