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Platelets Induced Vasodilation, in Vitro and in Vivo Study

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2005 by University Hospital, Angers.
Recruitment status was:  Recruiting
Information provided by:
University Hospital, Angers Identifier:
First received: September 7, 2005
Last updated: February 3, 2010
Last verified: September 2005

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.

Condition Intervention Phase
Peripheral Arterial Disease
Drug: placebo, aspirine, clopidogrel
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Platelets Induced Vasodilation, in Vitro and in Vivo Study in Patients With Arteriopathy and Healthy Subjects.

Further study details as provided by University Hospital, Angers:

Primary Outcome Measures:
  • 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

Estimated Enrollment: 36
Study Start Date: March 2005
Estimated Study Completion Date: January 2008

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00152646

Exploration Fonctionnelles Vasculaires Recruiting
Angers, Maine et Loire, France, 49933
Contact: Marc Antoine Custaud, MD PhD    33241353689   
Sponsors and Collaborators
University Hospital, Angers
Principal Investigator: Marc Antoine Custaud, MD PhD University Hospital, Angers
  More Information Identifier: NCT00152646     History of Changes
Other Study ID Numbers: PHRC 04-07
Study First Received: September 7, 2005
Last Updated: February 3, 2010

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs processed this record on April 26, 2017