Symptomatic Carotid StenosisMAPSNCT01053065
The Multicenter Atorvastatin Plaque Stabilization (MAPS) Study
A study testing Atorvastatin - Cholestyramine - Sitosterol in people with Symptomatic Carotid Stenosis and Hypercholesterolemia, run by University of Padova at 3 sites in Italy.
Trial summary
The impact on cardiovascular events achieved by statin therapy seems to be mostly attributable to the cholesterol-lowering effect with a highly debated contribution of the lipid-independent pleiotropic effects. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Symptomatic Carotid Stenosis, Hypercholesterolemia, Indication for Carotid Endarterectomy
- What is being tested?
- Atorvastatin - Cholestyramine - Sitosterol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesItaly
- Study dates
- Start not givento not given
- Phase
- Interventional
- 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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic carotid stenosis > 70% (NASCET criteria)
- Eligibility for carotid endarterectomy
- Total cholesterol level between 5.83 and 7.64 mmol/L
- Never treated with lipid lowering drugs
Who cannot join
- Previous lipid lowering therapy
- Total cholesterol <5.83 or >7.64 mmol/L
- Evidence of chronic inflammatory disease (clinical and laboratory).
- Patients at high risk for cerebrovascular events (i.e. ulcerated carotid plaque, recurrent TIAs).
Trial locations and contacts
3 sites in 1 country.
Italy3 sites
University of Chieti Medical School
Chieti, 66100
University of Padova Medical School
Padova, 35128
University of Padova Medical School - Treviso Branch
Treviso, 31100
About this study
The impact on cardiovascular events achieved by statin therapy seems to be mostly attributable to the cholesterol-lowering effect with a highly debated contribution of the lipid-independent pleiotropic effects. However, a short-term benefit has been documented for patients treated with statins in acute coronary syndromes and other clinical settings. These observations strengthened the hypothesis of additional, so-called pleiotropic actions of statins.
The investigators therefore sought to investigate how different lipid-lowering strategies (non-statin therapy, low-dose statin and high-dose statin) affects cellular composition of carotid plaque over a short-term period of three months. Specifically the investigators tried and dissect the LDL-C lowering impact on plaque cellular composition as compared to the lipid-independent contribution on plaque macrophage and smooth muscle cells.
Read the detailed description
Patients (with Total Cholesterol (TC) ranging between 5.83-7.64 mmol/l), never treated with lipid lowering drugs, with symptomatic carotid stenosis >70% (NASCET criteria), and therefore eligible for carotid endarterectomy, were recruited. All patients were enrolled within 30 days from the clinical event, and randomized to one of three treatment groups. Each group, composed of 20 patients, received atorvastatin 10 mg/day (AT-10 group), or atorvastatin 80 mg/day (AT-80 group), or cholestyramine (Questran, Bristol Myer Squibb) 8 g/day plus sitosterol (Unilever) 2.5 g/day (C-S group) for three months prior to the vascular procedure. A placebo group was not included for ethical reasons due to the high cardiovascular risk profile in this population.
- Being tested
- Atorvastatin - Cholestyramine - Sitosterol
- Keywords
- Atherosclerosis, Macrophages, Carotid arteries, Statin
- Medical subject headings
- Hypercholesterolemia, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atorvastatin - Cholestyramine - SitosterolDrug
| Study group | Role | What they receive |
|---|---|---|
| Atorvastatin 10 mg/day | Active comparator | Arm composed of 20 patients, receiving atorvastatin 10 mg/day Receives: Drug: Atorvastatin - Cholestyramine - Sitosterol |
| Atorvastatin 80 mg/day | Active comparator | Arm composed of 20 patients, receiving atorvastatin 80 mg/day Receives: Drug: Atorvastatin - Cholestyramine - Sitosterol |
| Cholestyramine - Sitosterol | Active comparator | Arm composed of 20 patients receiving cholestyramine 8 g/day plus sitosterol 2.5 g/day Receives: Drug: Atorvastatin - Cholestyramine - Sitosterol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in cellular composition of carotid plaque.
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Symptomatic Carotid StenosisStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Collaborators
- Biomedical Foundation for Cardiovascular Research of Padova, Pfizer
- Investigators
- Paolo Pauletto, MD, Principal investigator, University of Padova - Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01053065
- Sponsor's protocol ID
- MAPS
- Acronym
- MAPS
- Status last verified
- Jan 2005
- First submitted
- 20 Jan 2010
- Last updated
- 30 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Pauletto P, Puato M, Faggin E, Santipolo N, Pagliara V, Zoleo M, Deriu GP, Grego F, Plebani M, Sartore S, Bon GB, Heymes C, Samuel JL, Pessina AC. Specific cellular features of atheroma associated with development of neointima after carotid endarterectomy: the carotid atherosclerosis and restenosis study. Circulation. 2000 Aug 15;102(7):771-8. doi: 10.1161/01.cir.102.7.771.
PubMed 10942746Faggin E, Zambon A, Puato M, Deeb SS, Bertocco S, Sartore S, Crepaldi G, Pessina AC, Pauletto P. Association between the --514 C-->T polymorphism of the hepatic lipase gene promoter and unstable carotid plaque in patients with severe carotid artery stenosis. J Am Coll Cardiol. 2002 Sep 18;40(6):1059-66. doi: 10.1016/s0735-1097(02)02116-2.
PubMed 12354428
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Multicenter Atorvastatin Plaque Stabilization (MAPS) Study
- ClinicalTrials.gov ID
- NCT01053065
- Acronym / sponsor ID
- MAPS / MAPS
- Keywords
- Atherosclerosis, Macrophages, Carotid arteries, Statin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Collaborators
- Biomedical Foundation for Cardiovascular Research of Padova, Pfizer
- First posted
- 21 Jan 2010 (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 impact on cardiovascular events achieved by statin therapy seems to be mostly attributable to the cholesterol-lowering effect with a highly debated contribution of the lipid-independent pleiotropic effects. However, a short-term benefit has been documented for patients treated with statins in acute coronary syndromes and other clinical settings. These observations strengthened the hypothesis of additional, so-called pleiotropic actions of statins.
The investigators therefore sought to investigate how different lipid-lowering strategies (non-statin therapy, low-dose statin and high-dose statin) affects cellular composition of carotid plaque over a short-term period of three months. Specifically the investigators tried and dissect the LDL-C lowering impact on plaque cellular composition as compared to the lipid-independent contribution on plaque macrophage and smooth muscle cells.
Detailed description
Patients (with Total Cholesterol (TC) ranging between 5.83-7.64 mmol/l), never treated with lipid lowering drugs, with symptomatic carotid stenosis >70% (NASCET criteria), and therefore eligible for carotid endarterectomy, were recruited. All patients were enrolled within 30 days from the clinical event, and randomized to one of three treatment groups. Each group, composed of 20 patients, received atorvastatin 10 mg/day (AT-10 group), or atorvastatin 80 mg/day (AT-80 group), or cholestyramine (Questran, Bristol Myer Squibb) 8 g/day plus sitosterol (Unilever) 2.5 g/day (C-S group) for three months prior to the vascular procedure. A placebo group was not included for ethical reasons due to the high cardiovascular risk profile in this population.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Atorvastatin 10 mg/day | Active comparator | Drug: Atorvastatin - Cholestyramine - SitosterolArm composed of 20 patients, receiving atorvastatin 10 mg/day |
| Atorvastatin 80 mg/day | Active comparator | Drug: Atorvastatin - Cholestyramine - SitosterolArm composed of 20 patients, receiving atorvastatin 80 mg/day |
| Cholestyramine - Sitosterol | Active comparator | Drug: Atorvastatin - Cholestyramine - SitosterolArm composed of 20 patients receiving cholestyramine 8 g/day plus sitosterol 2.5 g/day |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Symptomatic carotid stenosis > 70% (NASCET criteria)
- Eligibility for carotid endarterectomy
- Total cholesterol level between 5.83 and 7.64 mmol/L
- Never treated with lipid lowering drugs
Key exclusion criteria (4 listed)
- Previous lipid lowering therapy
- Total cholesterol <5.83 or >7.64 mmol/L
- Evidence of chronic inflammatory disease (clinical and laboratory).
- Patients at high risk for cerebrovascular events (i.e. ulcerated carotid plaque, recurrent TIAs).
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 |
|---|---|---|
| Atorvastatin - Cholestyramine - Sitosterol | Drug | Atorvastatin 10 mg/day, Atorvastatin 80 mg/day, Cholestyramine - Sitosterol |
Primary outcome
Changes in cellular composition of carotid plaque.
Time frame: Three months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2021.
- Background: PubMed 10942746Pauletto P, Puato M, Faggin E, Santipolo N, Pagliara V, Zoleo M, Deriu GP, Grego F, Plebani M, Sartore S, Bon GB, Heymes C, Samuel JL, Pessina AC. Specific cellular features of atheroma associated with development of neointima after carotid endarterectomy: the carotid atherosclerosis and restenosis study. Circulation. 2000 Aug 15;102(7):771-8. doi: 10.1161/01.cir.102.7.771.
- Background: PubMed 12354428Faggin E, Zambon A, Puato M, Deeb SS, Bertocco S, Sartore S, Crepaldi G, Pessina AC, Pauletto P. Association between the --514 C-->T polymorphism of the hepatic lipase gene promoter and unstable carotid plaque in patients with severe carotid artery stenosis. J Am Coll Cardiol. 2002 Sep 18;40(6):1059-66. doi: 10.1016/s0735-1097(02)02116-2.
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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.
Paolo Pauletto, MD principal investigator
University of Padova - Italy
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Atorvastatin - Cholestyramine - Sitosterol in people with Symptomatic Carotid Stenosis and Hypercholesterolemia, run by University of Padova at 3 sites 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 4 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: finished, as of the sponsor's last update on 30 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in cellular composition of carotid plaque. (time frame: Three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01053065, which also lists 2 linked publications.
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 30 Apr 2021.