The Multicenter Atorvastatin Plaque Stabilization (MAPS) Study - Full Text View

Purpose

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	Intervention
Symptomatic Carotid Stenosis Hypercholesterolemia Indication for Carotid Endarterectomy	Drug: Atorvastatin - Cholestyramine - Sitosterol

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Basic Science
Official Title:	The Multicenter Atorvastatin Plaque Stabilization (MAPS) Study

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol Statins

Drug Information available for: Cholestyramine resin Atorvastatin calcium

U.S. FDA Resources

Further study details as provided by University of Padua:

Primary Outcome Measures:

Changes in cellular composition of carotid plaque. [ Time Frame: Three months ] [ Designated as safety issue: No ]

Enrollment:

60

Arms	Assigned Interventions
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

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.

Eligibility

Ages Eligible for Study:	50 Years to 85 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01053065

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

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
Study First Received:	January 20, 2010
Last Updated:	January 25, 2010
Health Authority:	Italy: National Institute of Health

Keywords provided by University of Padua:

Atherosclerosis
Macrophages
Carotid arteries
Statin

Additional relevant MeSH terms:

Carotid Stenosis
Hypercholesterolemia
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders

Metabolic Diseases
Cholestyramine Resin
Atorvastatin
Sitosterol
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on June 18, 2013