Mobilization of Endothelial Progenitor Cells Induced by Atorvastatin in Patients With Stable Coronary Artery Disease Treated With Anti-CD 34 Antibodies Coated Stents
Primary Purpose
Stable Coronary Artery Disease
Status
Terminated
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Atorvastatin
Atorvastatin
Sponsored by
About this trial
This is an interventional treatment trial for Stable Coronary Artery Disease
Eligibility Criteria
Inclusion Criteria:
- age between 18 and 75 years
- stable angina or silent ischemia
- documented CAD
- signed written informed consent
Exclusion Criteria:
- current or recent therapy (stop < 3 months) with statins
- allergy to ASA or ticlopidine/clopidogrel
- myocardial infarction (< 3 months)
- recent significant trauma or surgical interventions (< 3 mesi)
- significant renal or hepatic diseases
- coagulative-hematological disorders
- cancer
- inflammatory diseases
- myopathy
- pregnancy (a pregnancy test will be performed in fertile women)
- severe coronary calcification, or small vessels disease (< 2.5 mm), long lesions (> 20 mm), ostial lesions, bifurcation lesions requesting treatment of the collateral vessel, multi-vessel disease requiring PCI before the completion of the study
Sites / Locations
- Fondazione Irccs Policlinico San Matteo
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Atorvastatin 10 mg
Atorvastatin 80 mg
Arm Description
Outcomes
Primary Outcome Measures
To evaluate the extent of the mobilization of endothelial progenitor cells induced by low versus high dose atorvastatin after 4 weeks of treatment, in patients treated with anti-CD 34 antibodies coated stent.
Secondary Outcome Measures
Full Information
NCT ID
NCT00911339
First Posted
May 29, 2009
Last Updated
August 30, 2021
Sponsor
IRCCS Policlinico S. Matteo
1. Study Identification
Unique Protocol Identification Number
NCT00911339
Brief Title
Mobilization of Endothelial Progenitor Cells Induced by Atorvastatin in Patients With Stable Coronary Artery Disease Treated With Anti-CD 34 Antibodies Coated Stents
Official Title
Mobilization of Endothelial Progenitor Cells Induced by Atorvastatin in Patients With Stable Coronary Artery Disease Treated With Anti-CD 34 Antibodies Coated Stents
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Terminated
Why Stopped
prematurely interrupted because of difficulty in enrolment of patients.
Study Start Date
January 2009 (Actual)
Primary Completion Date
May 13, 2021 (Actual)
Study Completion Date
May 13, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS Policlinico S. Matteo
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the extent of the mobilization of endothelial progenitor cells induced by low versus high dose atorvastatin after 4 weeks of treatment, in patients treated with anti-CD 34 antibodies coated stent.
Detailed Description
Addition of statins to peripheral blood circulating mononuclear cells (PBMNCs) and to their CD 34+ subset cultures promotes endothelial progenitor cells (EPCs) proliferation, migration and survival according to a time and concentration-dependent effect. Data suggested that in patients with stable coronary artery disease atorvastatin 40 mg/day induced a 2 fold increase in the number of CD34+VEGFR2+ cells after 1 week of treatment and a 3 fold increase after 4 weeks; likewise, the number of EPCs colonies increased 1.5 times after 1 week and 3 times after 4 weeks. Data also suggested that the short term mobilizing effect of statins on EPCs may be transient and that medium-high doses long term statin treatment (> 1 month) may lead to a reduction in EPCs. Rather, a depletion of EPCs may not only be explained by exhausted mobilization but also by improved incorporation at sites of tissue hypoperfusion with potentially beneficial effects in therapeutic angiogenesis.In an interventional contest high concentrations of circulating EPCs may contribute to accelerate the reendothelialization process after stents implantation in coronary arteries. Considering the use of recent stents coated with anti-CD34 murine antibodies, the presence of high levels of PBMNCs expressing CD34 surface antigen may define the safety and efficacy levels of the procedure. Both the angiographic outcome and the clinical outcome seems to be better in patients with normal levels of EPCs than in patients with low levels. No data are available about the effects of different doses of statins on the biology of the PBMNCs and in particular about the timing of mobilization, duration of mobilization, the CD 34+ cell subset subpopulation mobilized and their gene expression balance in humans. No data are available about the effect of statins on clinical evolution in patients treated with PCI after the implantation of the stents coated by anti-CD34 murine antibodies.no specific data describing the effects of different doses of statins on the biology of the PBMNCs and in particular about the timing of mobilization, the duration of mobilization, the CD 34+ cell subset subpopulation mobilized and their gene expression balance in humans. No study has evaluated the effect of statins on clinical evolution in patients treated with PCI after the implantation of the new stents, coated by anti-CD34 murine antibodies. These data can contribute to better define the process of mobilization of endothelial progenitors induced by statins and to set up the best pharmacological strategy anti-CD34 coated stents deployment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stable Coronary Artery Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Atorvastatin 10 mg
Arm Type
Active Comparator
Arm Title
Atorvastatin 80 mg
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Intervention Description
Atorvastatin 10 mg associated with stent genous
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Intervention Description
Atorvastatin 80 mg associated with stent genous
Primary Outcome Measure Information:
Title
To evaluate the extent of the mobilization of endothelial progenitor cells induced by low versus high dose atorvastatin after 4 weeks of treatment, in patients treated with anti-CD 34 antibodies coated stent.
Time Frame
7-28-90 days after enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age between 18 and 75 years
stable angina or silent ischemia
documented CAD
signed written informed consent
Exclusion Criteria:
current or recent therapy (stop < 3 months) with statins
allergy to ASA or ticlopidine/clopidogrel
myocardial infarction (< 3 months)
recent significant trauma or surgical interventions (< 3 mesi)
significant renal or hepatic diseases
coagulative-hematological disorders
cancer
inflammatory diseases
myopathy
pregnancy (a pregnancy test will be performed in fertile women)
severe coronary calcification, or small vessels disease (< 2.5 mm), long lesions (> 20 mm), ostial lesions, bifurcation lesions requesting treatment of the collateral vessel, multi-vessel disease requiring PCI before the completion of the study
Facility Information:
Facility Name
Fondazione Irccs Policlinico San Matteo
City
Pavia
ZIP/Postal Code
27100
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Mobilization of Endothelial Progenitor Cells Induced by Atorvastatin in Patients With Stable Coronary Artery Disease Treated With Anti-CD 34 Antibodies Coated Stents
We'll reach out to this number within 24 hrs