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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-12-31

Study Completion Date

2004-04-30

Brief Summary

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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 independent/ on the microcirculation of the skin

Detailed Description

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Conditions

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Peripheral Arterial Disease

Keywords

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Fontain II-III stage

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Clopidogrel (Plavix)

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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sanofi-aventis

Principal Investigators

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Laszlo Eros

Role: STUDY_DIRECTOR

Sanofi

Locations

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Sanofi-Aventis

Budapest, , Hungary

Site Status

Countries

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Hungary

Other Identifiers

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L_8564

Identifier Type: -

Identifier Source: org_study_id