NCT00152646UnknownPhase 4
Platelets Induced Vasodilation, in Vitro and in Vivo Study in Patients With Arteriopathy and Healthy Subjects.
University Hospital, Angers2 sites in 1 country36 target enrollmentStarted: March 1, 2005Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Enrollment
- 36
- Locations
- 2
- Primary Endpoint
- In vivo vasodilation induced by low intensity current
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (2)
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