Platelets Induced Vasodilation, in Vitro and in Vivo Study

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Primary Purpose

Status

Unknown status

Phase

Phase 4

Locations

France

Study Type

Interventional

Intervention

placebo, aspirine, clopidogrel

About this trial

This is an interventional treatment trial for Peripheral Arterial Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Exploration Fonctionnelles VasculairesRecruiting

Outcomes

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

Secondary Outcome Measures

Full Information

NCT ID

NCT00152646

First Posted

September 7, 2005

Last Updated

February 3, 2010

Sponsor

University Hospital, Angers

1. Study Identification

Unique Protocol Identification Number

NCT00152646

Brief Title

Platelets Induced Vasodilation, in Vitro and in Vivo Study

Official Title

Platelets Induced Vasodilation, in Vitro and in Vivo Study in Patients With Arteriopathy and Healthy Subjects.

Study Type

Interventional

2. Study Status

Record Verification Date

September 2005

Overall Recruitment Status

Unknown status

Study Start Date

March 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

January 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

University Hospital, Angers

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peripheral Arterial Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

Double

Allocation

Randomized

Enrollment

36 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

placebo, aspirine, clopidogrel

Primary Outcome Measure Information:

Title

In vivo vasodilation induced by low intensity current

Title

In vitro study of platelets function

Title

In vitro vasodilation induced by platelets in isolated rat's vessels

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marc Antoine Custaud, MD PhD

Organizational Affiliation

University Hospital, Angers

Official's Role

Principal Investigator

Facility Information:

Facility Name

Exploration Fonctionnelles Vasculaires

City

Angers

State/Province

Maine et Loire

ZIP/Postal Code

49933

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Marc Antoine Custaud, MD PhD

Phone

33241353689

Email

macustaud@chu-angers.fr

Peripheral Arterial Disease

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial