- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00911339
Mobilization of Endothelial Progenitor Cells Induced by Atorvastatin in Patients With Stable Coronary Artery Disease Treated With Anti-CD 34 Antibodies Coated Stents
August 30, 2021 updated by: FERRARIO, IRCCS Policlinico S. Matteo
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
13
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Pavia, Italy, 27100
- Fondazione IRCCS Policlinico San Matteo
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Atorvastatin 10 mg
|
Atorvastatin 10 mg associated with stent genous
Atorvastatin 80 mg associated with stent genous
|
Active Comparator: Atorvastatin 80 mg
|
Atorvastatin 10 mg associated with stent genous
Atorvastatin 80 mg associated with stent genous
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
7-28-90 days after enrollment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2009
Primary Completion (Actual)
May 13, 2021
Study Completion (Actual)
May 13, 2021
Study Registration Dates
First Submitted
May 29, 2009
First Submitted That Met QC Criteria
May 29, 2009
First Posted (Estimate)
June 1, 2009
Study Record Updates
Last Update Posted (Actual)
August 31, 2021
Last Update Submitted That Met QC Criteria
August 30, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Coronary Artery Disease
- Myocardial Ischemia
- Coronary Disease
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Atorvastatin
Other Study ID Numbers
- Atorvastatin-CD34+
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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