Platelets Induced Vasodilation, in Vitro and in Vivo Study

NCT ID: NCT00152646

Last Updated: 2010-02-04

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

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2008-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Peripheral Arterial Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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placebo, aspirine, clopidogrel

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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)

Exclusion Criteria

* Unable to sign agreement
* Subjects protected by low
* Participation to other study
* Changes of treatment within the 15 days before inclusion
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Angers

OTHER_GOV

Sponsor Role lead

Principal Investigators

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Marc Antoine Custaud, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Angers

Locations

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Exploration Fonctionnelles Vasculaires

Angers, Maine et Loire, France

Site Status RECRUITING

Countries

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France

Facility Contacts

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Marc Antoine Custaud, MD PhD

Role: primary

33241353689

Other Identifiers

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PHRC 04-07

Identifier Type: -

Identifier Source: org_study_id

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