NCT00152646

Brief Summary

The aim of the study is to show the implication of platelets in vasodilation using in vivo and in vitro analysis and to compare the effects of placebo, aspirin and Clopidogrel in this interaction platelets/vessels. The effects of 7 days of each treatment will be compared in healthy subjects and patients with arteriopathy.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2005

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

March 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 9, 2005

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

February 4, 2010

Status Verified

September 1, 2005

First QC Date

September 7, 2005

Last Update Submit

February 3, 2010

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (3)

  • In vivo vasodilation induced by low intensity current

  • In vitro study of platelets function

  • In vitro vasodilation induced by platelets in isolated rat's vessels

Interventions

placebo, aspirine, clopidogrelDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Man or Woman 18 years
  • Agreement signed
  • French health insurance
  • Able to understand the study
  • Biological haemostatic test normal
  • Vascular Doppler of lower limbs normal
  • Pressure index \> 1 in both lower limbs
  • Man or Woman 18 years
  • Agreement signed
  • French health insurance
  • Able to understand the study
  • Biological haemostatic test normal
  • Lower limbs arteriopathy (clinical, pressure index, Doppler)

You may not qualify if:

  • Unable to sign agreement
  • Subjects protected by low
  • Participation to other study
  • Chronic treatment with Clopidogrel or drugs against inflammation
  • Severe respiratory, cardiac, kidney, hepatic insufficiency
  • Haemostatic troubles
  • Diabetic neuropathy
  • Neurologic desease (Parkinson…..)
  • Hypertension
  • Symptomatic stomach ulcer
  • Anaemia Hb\<11g/l
  • Pregnant women or breast feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Exploration Fonctionnelles Vasculaires

Angers, Maine et Loire, 49933, France

RECRUITING

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

  • Marc Antoine Custaud, MD PhD

    University Hospital, Angers

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

September 7, 2005

First Posted

September 9, 2005

Study Start

March 1, 2005

Study Completion

January 1, 2008

Last Updated

February 4, 2010

Record last verified: 2005-09

Locations

FR(1)