Platelets Induced Vasodilation, in Vitro and in Vivo Study

Phase 4

• Conditions: Peripheral Arterial Disease

• Registration Number: NCT00152646
• Lead Sponsor: University Hospital, Angers

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

Not available

Study Timeline

• Study Start: 2005-03
• Status Verified: 2005-09
• Study First Submitted: 2005-09-07
• Study First Submitted QC: 2005-09-07
• Study First Posted: 2005-09-09
• Study Completion: 2008-01
• Last Update Submitted: 2010-02-03
• Last Update Posted: 2010-02-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Exploration Fonctionnelles Vasculaires; 🇫🇷 Angers, Maine et Loire, France