Peripheral Arterial DiseasePhase 4NCT00152646
Platelets Induced Vasodilation, in Vitro and in Vivo Study
A Phase 4 study of Peripheral Arterial Disease, run by University Hospital, Angers at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peripheral Arterial Disease
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2005to Jan 2008
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- Pressure index > 1 in both lower limbs
- 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)
Who cannot join
- 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
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- Haemostatic troubles
- Diabetic neuropathy
- Neurologic desease (Parkinson…..)
- Hypertension
- Symptomatic stomach ulcer
- Anaemia Hb<11g/l
- Pregnant women or breast feeding
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Exploration Fonctionnelles Vasculaires
Angers, Maine et Loire, 49933
Marc Antoine Custaud, MD PhD, 33241353689, macustaud@chu-angers.fr
About this study
Official title: Platelets Induced Vasodilation, in Vitro and in Vivo Study in Patients With Arteriopathy and Healthy Subjects.
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.
- Conditions
- Peripheral Arterial Disease
- Being tested
- placebo, aspirine, clopidogrel
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placebo, aspirine, clopidogrelDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2005 (estimated)
- Study startMar 2005
- Study completionJan 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Investigators
- Marc Antoine Custaud, MD PhD, Principal investigator, University Hospital, Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00152646
- Sponsor's protocol ID
- PHRC 04-07
- Status last verified
- Sep 2005
- First submitted
- 7 Sep 2005
- Last updated
- 4 Feb 2010
- Results posted
- No
- Data monitoring committee
- Yes