Platelets Induced Vasodilation, in Vitro and in Vivo Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by University Hospital, Angers.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital, Angers
ClinicalTrials.gov Identifier:
NCT00152646
First received: September 7, 2005
Last updated: February 3, 2010
Last verified: September 2005
  Purpose

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
Endpoint Classification: Efficacy Study
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.

Resource links provided by NLM:


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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00152646     History of Changes
Other Study ID Numbers: PHRC 04-07
Study First Received: September 7, 2005
Last Updated: February 3, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on September 29, 2014