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Platelets Induced Vasodilation, in Vitro and in Vivo Study

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ClinicalTrials.gov Identifier: NCT00152646
Recruitment Status : Unknown
Verified September 2005 by University Hospital, Angers.
Recruitment status was:  Recruiting
First Posted : September 9, 2005
Last Update Posted : February 4, 2010
Sponsor:
Information provided by:
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.


Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Drug: placebo, aspirine, clopidogrel Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Platelets Induced Vasodilation, in Vitro and in Vivo Study in Patients With Arteriopathy and Healthy Subjects.
Study Start Date : March 2005
Estimated Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Clopidogrel
U.S. FDA Resources




Primary Outcome Measures :
  1. In vivo vasodilation induced by low intensity current
  2. In vitro study of platelets function
  3. In vitro vasodilation induced by platelets in isolated rat's vessels


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00152646


Locations
France
Exploration Fonctionnelles Vasculaires Recruiting
Angers, Maine et Loire, France, 49933
Contact: Marc Antoine Custaud, MD PhD    33241353689    macustaud@chu-angers.fr   
Sponsors and Collaborators
University Hospital, Angers
Investigators
Principal Investigator: Marc Antoine Custaud, MD PhD University Hospital, Angers

ClinicalTrials.gov Identifier: NCT00152646     History of Changes
Other Study ID Numbers: PHRC 04-07
First Posted: September 9, 2005    Key Record Dates
Last Update Posted: February 4, 2010
Last Verified: September 2005

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Clopidogrel
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