Ignite Creation Date:
2024-05-05 @ 9:35 PM
Last Modification Date:
2024-10-26 @ 10:06 AM
Study NCT ID:
NCT00911339
Status:
TERMINATED
Last Update Posted:
2021-08-31
First Post:
2009-05-29
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
Sponsor:
Fondazione IRCCS Policlinico San Matteo di Pavia
Organization:
Fondazione IRCCS Policlinico San Matteo di Pavia
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2021-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
prematurely interrupted because of difficulty in enrolment of patients
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 mgday induced a 2 fold increase in the number of CD34VEGFR2 cells after 1 week of treatment and a 3 fold increase after 4 weeks likewise the number of EPCs colonies increased 15 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 angiogenesisIn 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 antibodiesno 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None