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 (Participant) Primary Purpose: Basic Science
Official Title:	The Multicenter Atorvastatin Plaque Stabilization (MAPS) Study

Resource links provided by NLM:

Drug Information available for: Cholestyramine resin Atorvastatin Atorvastatin calcium Atorvastatin calcium trihydrate

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 ]


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 (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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

ClinicalTrials.gov processed this record on June 22, 2017

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