The Multicenter Atorvastatin Plaque Stabilization (MAPS) Study (MAPS)

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Symptomatic Carotid Stenosis; Hypercholesterolemia; Indication for Carotid Endarterectomy	Drug: Atorvastatin - Cholestyramine - Sitosterol	Not Applicable

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

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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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Active Comparator: Atorvastatin 10 mg/day; Arm composed of 20 patients, receiving atorvastatin 10 mg/day	Drug: Atorvastatin - Cholestyramine - Sitosterol
Active Comparator: Atorvastatin 80 mg/day; Arm composed of 20 patients, receiving atorvastatin 80 mg/day	Drug: Atorvastatin - Cholestyramine - Sitosterol
Active Comparator: Cholestyramine - Sitosterol; Arm composed of 20 patients receiving cholestyramine 8 g/day plus sitosterol 2.5 g/day	Drug: Atorvastatin - Cholestyramine - Sitosterol

Outcome Measures

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Primary Outcome Measures :

1. Changes in cellular composition of carotid plaque. [ Time Frame: Three months ]

Eligibility Criteria

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Ages Eligible for Study:	50 Years to 85 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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).

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

Sponsors and Collaborators

University of Padua

Biomedical Foundation for Cardiovascular Research of Padova

Pfizer

Investigators

Principal Investigator:	Paolo Pauletto, MD	University of Padova - Italy

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Faggin 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.

ClinicalTrials.gov Identifier:	NCT01053065 History of Changes
Other Study ID Numbers:	MAPS
First Posted:	January 21, 2010
Last Update Posted:	January 26, 2010
Last Verified:	January 2005

Keywords provided by University of Padua:

Atherosclerosis; Macrophages; Carotid arteries; Statin

Additional relevant MeSH terms:

Hypercholesterolemia; Carotid Stenosis; 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 Calcium; Cholestyramine Resin; Gamma-sitosterol; Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Enzyme Inhibitors