Platelets Induced Vasodilation, in Vitro and in Vivo Study

This study is currently recruiting participants.

Verified by University Hospital, Angers, September 2005

Sponsored by:	University Hospital, Angers
Information provided by:	University Hospital, Angers
ClinicalTrials.gov Identifier:	NCT00152646

Purpose

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.

Condition	Intervention	Phase
Arteriopathy	Drug: placebo, aspirine, clopidogrel	Phase IV

Drug Information available for: Clopidogrel Clopidogrel Bisulfate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study
Official Title:	Platelets Induced Vasodilation, in Vitro and in Vivo Study in Patients With Arteriopathy and Healthy Subjects.

Further study details as provided by University Hospital, Angers:

Primary Outcome Measures:

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

Estimated Enrollment:	36
Study Start Date:	March 2005

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Inclusion criteria healthy subjects

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

Inclusion criteria healthy subjects

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00152646

Locations

France, Maine et Loire
Exploration Fonctionnelles Vasculaires	Recruiting
Angers, Maine et Loire, France, 49933
Contact: Marc Antoine Custaud, MD PhD 33241353689 macustaud@chu-angers.fr

Sponsors and Collaborators

University Hospital, Angers

Investigators

Principal Investigator:

Marc Antoine Custaud, MD PhD

CHU ANGERS

More Information

Study ID Numbers:	PHRC 04-07
Study First Received:	September 7, 2005
Last Updated:	September 7, 2005
ClinicalTrials.gov Identifier:	NCT00152646
Health Authority:	France: Afssaps - French Health Products Safety Agency

Study placed in the following topic categories:

Clopidogrel
Healthy

Additional relevant MeSH terms:

Therapeutic Uses
Hematologic Agents
Platelet Aggregation Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009