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

Primary Purpose

Peripheral Arterial Disease

Status

Completed

Phase

Phase 4

Locations

Hungary

Study Type

Interventional

Intervention

Clopidogrel (Plavix)

About this trial

This is an interventional treatment trial for Peripheral Arterial Disease focused on measuring Fontain II-III stage

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Sanofi-Aventis

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Safety of clopidogrel /75 mg/day/ treatment

Full Information

NCT ID

NCT00648453

First Posted

March 28, 2008

Last Updated

April 1, 2008

Sponsor

Sanofi

Collaborators

Bristol-Myers Squibb

1. Study Identification

Unique Protocol Identification Number

NCT00648453

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2008

Overall Recruitment Status

Completed

Study Start Date

December 2002 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

April 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Sanofi

Collaborators

Bristol-Myers Squibb

4. Oversight

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peripheral Arterial Disease

Keywords

Fontain II-III stage

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

39 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Clopidogrel (Plavix)

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

Safety of clopidogrel /75 mg/day/ treatment

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Laszlo Eros

Organizational Affiliation

Sanofi

Official's Role

Study Director

Facility Information:

Facility Name

Sanofi-Aventis

City

Budapest

Country

Hungary

12. IPD Sharing Statement

Learn more about this trial

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

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