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NCT00152646 Clinical Trial

Platelets Induced Vasodilation, in Vitro and in Vivo Study

Peripheral Arterial Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00152646
Other study ID # PHRC 04-07
Secondary ID
Status Recruiting
Phase Phase 4
First received September 7, 2005
Last updated February 3, 2010
Start date March 2005
Est. completion date January 2008

Study information
Verified date September 2005
Source University Hospital, Angers
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 36
Est. completion date January 2008
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• placebo, aspirine, clopidogrel

Locations
Country Name City State
France Exploration Fonctionnelles Vasculaires Angers Maine et Loire

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary In vivo vasodilation induced by low intensity current
Primary In vitro study of platelets function
Primary In vitro vasodilation induced by platelets in isolated rat's vessels
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