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The Multicenter Atorvastatin Plaque Stabilization (MAPS) Study

The Multicenter Atorvastatin Plaque Stabilization (MAPS) Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01053065
Acronym
MAPS
Enrollment
60
Registered
2010-01-21
Start date
Unknown
Completion date
Unknown
Last updated
2021-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercholesterolemia, Indication for Carotid Endarterectomy, Symptomatic Carotid Stenosis

Keywords

Atherosclerosis, Macrophages, Carotid arteries, Statin

Brief 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. 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.

Interventions

DRUGAtorvastatin - Cholestyramine - Sitosterol

Sponsors

Biomedical Foundation for Cardiovascular Research of Padova
CollaboratorUNKNOWN
Pfizer
CollaboratorINDUSTRY
University of Padova
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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).

Design outcomes

Primary

MeasureTime frame
Changes in cellular composition of carotid plaque.Three months

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026