NCT00648453

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Dec 2002

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2002

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2004

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

March 28, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 1, 2008

Completed
Last Updated

April 3, 2008

Status Verified

April 1, 2008

First QC Date

March 28, 2008

Last Update Submit

April 1, 2008

Conditions

Peripheral Arterial Disease

Keywords

Fontain II-III stage

Outcome Measures

Primary Outcomes (1)

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

    3 months

Secondary Outcomes (1)

  • Safety of clopidogrel /75 mg/day/ treatment

    3 months

Interventions

Clopidogrel (Plavix)DRUG

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Proven, peripheral arterial disease, Fontain II-III stage, patient submitted to secondary prophylactic thrombocyte aggregation inhibiting treatment
  • Doppler index \< 0,8

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanofi-Aventis

Budapest, Hungary

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Clopidogrel

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

TiclopidineThienopyridinesThiophenesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Laszlo Eros

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 28, 2008

First Posted

April 1, 2008

Study Start

December 1, 2002

Study Completion

April 1, 2004

Last Updated

April 3, 2008

Record last verified: 2008-04

Locations

HU(1)