Platelets Induced Vasodilation, in Vitro and in Vivo Study

University Hospital, Angers

Status and phase: Unknown; Phase 4

Conditions: Peripheral Arterial Disease

Treatments: Drug: placebo, aspirine, clopidogrel

Study type: Interventional

Funder types: Other

Identifiers

NCT00152646

PHRC 04-07

Details and patient eligibility

About

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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind