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

This study has been completed.

First Received on March 28, 2008. Last Updated on April 1, 2008 History of Changes

Sponsor:	Sanofi-Aventis
Collaborator:	Bristol-Myers Squibb
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00648453

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 IV

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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:

MedlinePlus related topics: Coronary Artery Disease Heart Diseases Peripheral Arterial Disease

Drug Information available for: Nitric oxide Clopidogrel Clopidogrel Bisulfate

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

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

Ages Eligible for Study:	30 Years to 70 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00648453

Locations

Hungary
Sanofi-Aventis
Budapest, Hungary

Sponsors and Collaborators

Sanofi-Aventis

Bristol-Myers Squibb

Investigators

Study Director:

Laszlo Eros

Sanofi-Aventis

More Information

No publications provided

Responsible Party:	Study Director, sanofi-aventis
ClinicalTrials.gov Identifier:	NCT00648453 History of Changes
Other Study ID Numbers:	L_8564
Study First Received:	March 28, 2008
Last Updated:	April 1, 2008
Health Authority:	Hungary: Orszagos Gyogyszereszeti Intezet

Keywords provided by Sanofi-Aventis:

Fontain II-III stage

Additional relevant MeSH terms:

Coronary Disease
Peripheral Arterial Disease
Peripheral Vascular Diseases
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Nitric Oxide
Clopidogrel
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents

Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Cardiovascular Agents
Protective Agents
Platelet Aggregation Inhibitors
Hematologic Agents

ClinicalTrials.gov processed this record on February 09, 2012