Platelets Induced Vasodilation, in Vitro and in Vivo Study

The recruitment status of this study is unknown because the information has not been verified recently.

Verified September 2005 by University Hospital, Angers. Recruitment status was Recruiting

First Received on September 7, 2005. Last Updated on February 3, 2010 History of Changes

Sponsor:	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
Peripheral Arterial Disease	Drug: placebo, aspirine, clopidogrel	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Platelets Induced Vasodilation, in Vitro and in Vivo Study in Patients With Arteriopathy and Healthy Subjects.

Resource links provided by NLM:

MedlinePlus related topics: Peripheral Arterial Disease

Drug Information available for: Clopidogrel Clopidogrel Bisulfate

U.S. FDA Resources

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
Estimated Study Completion Date:	January 2008

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
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

University Hospital, Angers

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00152646 History of Changes
Other Study ID Numbers:	PHRC 04-07
Study First Received:	September 7, 2005
Last Updated:	February 3, 2010
Health Authority:	France: Afssaps - French Health Products Safety Agency

Additional relevant MeSH terms:

Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Clopidogrel
Platelet Aggregation Inhibitors
Hematologic Agents

Therapeutic Uses
Pharmacologic Actions
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 12, 2012