Clinical Trials Logo
  1. Home
  2. Peripheral Arterial Disease
  3. NCT00152646
  4. Details
NCT00152646 Clinical Trial

Platelets Induced Vasodilation, in Vitro and in Vivo Study

Peripheral Arterial Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00152646
Other study ID # PHRC 04-07
Secondary ID
Status Recruiting
Phase Phase 4
First received September 7, 2005
Last updated February 3, 2010
Start date March 2005
Est. completion date January 2008

Study information
Verified date September 2005
Source University Hospital, Angers
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical 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.

The effects of 7 days of each treatment will be compared in healthy subjects and patients with arteriopathy.

Recruitment information / eligibility
Status Recruiting
Enrollment 36
Est. completion date January 2008
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• placebo, aspirine, clopidogrel

Locations
Country Name City State
France Exploration Fonctionnelles Vasculaires Angers Maine et Loire

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary In vivo vasodilation induced by low intensity current
Primary In vitro study of platelets function
Primary In vitro vasodilation induced by platelets in isolated rat's vessels
See also
  Status Clinical Trial Phase
Recruiting NCT06032065 - Sequential Multiple Assessment Randomized Trial of Exercise for PAD: SMART Exercise for PAD (SMART PAD) Phase 3
Active, not recruiting NCT03987061 - MOTIV Bioresorbable Scaffold in BTK Artery Disease N/A
Recruiting NCT03506633 - Impacts of Mitochondrial-targeted Antioxidant on Peripheral Artery Disease Patients N/A
Active, not recruiting NCT03506646 - Dietary Nitrate Supplementation and Thermoregulation N/A
Active, not recruiting NCT04677725 - NEtwork to Control ATherothrombosis (NEAT Registry)
Recruiting NCT05961943 - RESPONSE-2-PAD to Reduce Sedentary Time in Peripheral Arterial Disease Patients N/A
Recruiting NCT06047002 - Personalised Antiplatelet Therapy for Patients With Symptomatic Peripheral Arterial Disease
Completed NCT03185052 - Feasibility of Outpatient Care After Manual Compression in Patients Treated for Peripheral Arterial Disease by Endovascular Technique With 5F Sheath Femoral Approach N/A
Recruiting NCT05992896 - A Study of Loco-Regional Liposomal Bupivacaine Injection Phase 4
Completed NCT04635501 - AbsorbaSeal (ABS 5.6.7) Vascular Closure Device Trial N/A
Recruiting NCT04584632 - The Efemoral Vascular Scaffold System (EVSS) for the Treatment of Patients With Symptomatic Peripheral Vascular Disease From Stenosis or Occlusion of the Femoropopliteal Artery N/A
Withdrawn NCT03994185 - The Merit WRAPSODY™ Endovascular Stent Graft for Treatment of Iliac Artery Occlusive Disease N/A
Withdrawn NCT03538392 - Serranator® Alto Post Market Clinical Follow Up (PMCF) Study
Recruiting NCT02915796 - Autologous CD133(+) Cells as an Adjuvant to Below the Knee Percutaneous Transluminal Angioplasty Phase 1
Active, not recruiting NCT02900924 - Observational Study to Evaluate the BioMimics 3D Stent System: MIMICS-3D
Completed NCT02901847 - To Evaluate the Introduction of a Public Health Approach to Peripheral Arterial Disease (PAD) Using National Centre for Sport and Exercise Medicine Facilities. N/A
Not yet recruiting NCT02387450 - Reduced Cardiovascular Morbi-mortality by Sildenafil in Patients With Arterial Claudication Phase 2/Phase 3
Not yet recruiting NCT02455726 - Magnesium Oral Supplementation to Reduce Pain Inpatients With Severe Peripheral Arterial Occlusive Disease N/A
Withdrawn NCT02126540 - Trial of Pantheris System, an Atherectomy Device That Provides Imaging While Removing Plaque in Lower Extremity Arteries N/A
Completed NCT02384980 - Saving Life and Limb: FES for the Elderly With PAD Phase 1