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
- Are there results?
- None posted in the registry
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.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelets Induced Vasodilation, in Vitro and in Vivo Study in Patients With Arteriopathy and Healthy Subjects.
- ClinicalTrials.gov ID
- NCT00152646
- Acronym / sponsor ID
- PHRC 04-07
- Conditions
- Peripheral Arterial Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- Mar 2005
- Study completion
- Jan 2008 (estimated)
- First posted
- 9 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Man or Woman 18 years
- Agreement signed
- French health insurance
- Able to understand the study
- Biological haemostatic test normal
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| placebo, aspirine, clopidogrel | Drug | – |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Antoine Custaud, MD PhD principal investigator
University Hospital, Angers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study of Peripheral Arterial Disease, run by University Hospital, Angers at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In vivo vasodilation induced by low intensity current. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2010.