Stable Coronary Artery DiseasePhase 3NCT00911339
Mobilization of Endothelial Progenitor Cells Induced by Atorvastatin in Patients With Stable Coronary Artery Disease Treated With Anti-CD 34 Antibodies Coated Stents
A Phase 3 study testing Atorvastatin in people with Stable Coronary Artery Disease, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stable Coronary Artery Disease
- What is being tested?
- Atorvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2009to 13 May 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age between 18 and 75 years
- stable angina or silent ischemia
- documented CAD
- signed written informed consent
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Stable Coronary Artery Disease
- Being tested
- Atorvastatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
Atorvastatin 10 mg associated with stent genous
AtorvastatinDrug
Atorvastatin 80 mg associated with stent genous
| Study group | Role | What they receive |
|---|---|---|
| Atorvastatin 10 mg | Active comparator | Not described Receives: Drug: Atorvastatin |
| Atorvastatin 80 mg | Active comparator | Not described Receives: Drug: Atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7-28-90 days after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2009 (estimated)
- Study startJan 2009
- Primary completion13 May 2021
- Study completion13 May 2021
Why it stopped: prematurely interrupted because of difficulty in enrolment of patients.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stable Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Policlinico San Matteo di PaviaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, FERRARIO, Fondazione IRCCS Policlinico San Matteo di Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00911339
- Sponsor's protocol ID
- Atorvastatin-CD34+
- Status last verified
- Aug 2021
- First submitted
- 29 May 2009
- Last updated
- 31 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00911339
- Acronym / sponsor ID
- Atorvastatin-CD34+
- Conditions
- Stable Coronary Artery Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: prematurely interrupted because of difficulty in enrolment of patients.
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Study start
- Jan 2009 (actual)
- Primary completion
- 13 May 2021 (actual)
- Study completion
- 13 May 2021 (actual)
- First posted
- 1 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atorvastatin 10 mg | Active comparator | Drug: Atorvastatin |
| Atorvastatin 80 mg | Active comparator | Drug: Atorvastatin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age between 18 and 75 years
- stable angina or silent ischemia
- documented CAD
- signed written informed consent
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtorvastatinAtorvastatin 10 mg associated with stent genous | Drug | Atorvastatin 10 mg |
| AtorvastatinAtorvastatin 80 mg associated with stent genous | Drug | Atorvastatin 80 mg |
Primary outcome
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
Results and safety
The study was stopped early (reason given: prematurely interrupted because of difficulty in enrolment of patients.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2021.
Related trials for Stable Coronary Artery Disease
Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Coronary Artery Disease, Chest Syndrome
Recruiting
Intracoronary Cryotherapy Effect on Stabilization of Vulnerable Plaque in Patients With Stable Angina or ACS - A Traditional Feasibility Study
Coronary Arterial Disease (CAD), Plaque
Recruiting
Multivessel Balloon Occlusion to Investigate Obstructive Coronary Artery Disease and aNgina
Stable Angina, Multivessel Coronary Artery Disease
RecruitingPhase 3
Comparing High and lOw-dose asPirin With Dual anTIplatelet Therapy for Three Months Using prasUgrel and aSpirin Following Coronary Artery Bypass Grafting. (OPTIMUS-CABG Trial)
Chronic Coronary Syndrome, Stable Coronary Artery Disease CAD
RecruitingPhase 4
Flecainide Safety in Patients With Coronary Artery Disease and Atrial Fibrillation
Atrial Fibrillation (AF), Coronary Artery Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Atorvastatin in people with Stable Coronary Artery Disease, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: prematurely interrupted because of difficulty in enrolment of patients.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2021.