Platelets Induced Vasodilation, in Vitro and in Vivo Study - Tabular View

Tracking Information

First Received Date ^ICMJE

September 7, 2005

Last Updated Date

September 7, 2005

Start Date ^ICMJE

March 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Platelets Induced Vasodilation, in Vitro and in Vivo Study

Official Title ^ICMJE

Platelets Induced Vasodilation, in Vitro and in Vivo Study in Patients With Arteriopathy and Healthy Subjects.

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.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study

Condition ^ICMJE

Arteriopathy

Intervention ^ICMJE

Drug: placebo, aspirine, clopidogrel

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Location Countries ^ICMJE

France

Administrative Information

NCT ID ^ICMJE

NCT00152646

Responsible Party

Study ID Numbers ^ICMJE

PHRC 04-07

Study Sponsor ^ICMJE

University Hospital, Angers

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Marc Antoine Custaud, MD PhD

University Hospital, Angers

Information Provided By

University Hospital, Angers

Verification Date

September 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP