The Multicenter Atorvastatin Plaque Stabilization (MAPS) Study (MAPS)
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ClinicalTrials.gov Identifier: NCT01053065 |
Recruitment Status :
Completed
First Posted : January 21, 2010
Last Update Posted : April 30, 2021
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Symptomatic Carotid Stenosis Hypercholesterolemia Indication for Carotid Endarterectomy | Drug: Atorvastatin - Cholestyramine - Sitosterol | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Basic Science |
Official Title: | The Multicenter Atorvastatin Plaque Stabilization (MAPS) Study |

Arm | Intervention/treatment |
---|---|
Active Comparator: Atorvastatin 10 mg/day
Arm composed of 20 patients, receiving atorvastatin 10 mg/day
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Drug: Atorvastatin - Cholestyramine - Sitosterol |
Active Comparator: Atorvastatin 80 mg/day
Arm composed of 20 patients, receiving atorvastatin 80 mg/day
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Drug: Atorvastatin - Cholestyramine - Sitosterol |
Active Comparator: Cholestyramine - Sitosterol
Arm composed of 20 patients receiving cholestyramine 8 g/day plus sitosterol 2.5 g/day
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Drug: Atorvastatin - Cholestyramine - Sitosterol |
- Changes in cellular composition of carotid plaque. [ Time Frame: Three months ]

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Ages Eligible for Study: | 50 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01053065
Italy | |
University of Chieti Medical School | |
Chieti, Italy, 66100 | |
University of Padova Medical School | |
Padova, Italy, 35128 | |
University of Padova Medical School - Treviso Branch | |
Treviso, Italy, 31100 |
Principal Investigator: | Paolo Pauletto, MD | University of Padova - Italy |
ClinicalTrials.gov Identifier: | NCT01053065 |
Other Study ID Numbers: |
MAPS |
First Posted: | January 21, 2010 Key Record Dates |
Last Update Posted: | April 30, 2021 |
Last Verified: | January 2005 |
Atherosclerosis Macrophages Carotid arteries Statin |
Carotid Stenosis Hypercholesterolemia Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Carotid Artery Diseases Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Arterial Occlusive Diseases |
Vascular Diseases Cardiovascular Diseases Atorvastatin Cholestyramine Resin Gamma-sitosterol Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors |