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The Multicentre Atorvastatin Plaque Stabilisation (MAPS) Study

Proposed Rationale and Study Design

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Abstract

Background: Inflammatory mechanisms are thought to play a key role in the development of atherosclerosis and unstable plaque. In the past, numerous studies have reported that the statins have an antiinflammatory and anti-atherosclerotic effect unrelated to lipid-lowering. However, it is still difficult to estimate the contribution of the specific cholesterol-independent effects of statins in counteracting the atherosclerotic process and its sequelae.

Aim: To establish whether a short-term (3-month) treatment with atorvastatin at high versus low dose leads to changes in carotid plaque structure and biology in terms of cellular/extracellular composition, markers of inflammation, cell adhesion, and thrombosis. For comparison, the effect of another cholesterol-lowering treatment will also be evaluated.

Study design: A randomised, multicentre, double-bind, parallel group study will be conducted involving 225 patients. The patients will have hypercholesterolaemia (serum total cholesterol 225–295 mg/dL) with carotid stenosis ≥70% and be planning to undergo an endarterectomy procedure. During the 3 months prior to the procedure, the patients will be randomly divided into three groups. Each group received atorvastatin 10 mg/day, atorvastatin 80 mg/day, or cholestyramine 8 g/day plus sitosterol 2.5 g/day, respectively.

Expected results: The effectiveness of atorvastatin versus control medication in inducing a favourable plaque remodelling (stabilisation), a reduced level of inflammation (local and systemic), and the effectiveness of a high versus low dose of atorvastatin therapy.

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Acknowledgements

The authors have no conflicts of interest directly relevant to the content of this study.

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Authors and Affiliations

  1. Department of Clinical and Experimental Medicine, University of Padua, O.U. of Internal Medicine, Ospedale Ca’ Foncello, 31100, Treviso, Italy

    Paolo Pauletto

  2. Department of Internal Medicine and Public Health, University of L’Aquila, L’Aquila, Italy

    Claudio Ferri & Giovambattista Desideri

  3. II Faculty of Medicine, University of Rome “La Sapienza”, Rome, Italy

    Massimo Volpe & Luca De Siati

  4. Department of Medical and Surgical Sciences, University of Brescia, Brescia, Italy

    Enrico Agabiti-Rosei, Maria Lorenza Muiesan & Massimo Salvetti

  5. Department of Clinical and Experimental Medicine, University of Padua, Padua, Italy

    Massimo Puato, Elisabetta Faggin & Marcello Rattazzi

  6. Department of Laboratory Medicine, University-Hospital of Padua, Padua, Italy

    Mario Plebani

  7. Departments of Medical and Surgical Sciences, University of Padua, Padua, Italy

    Alberto Zambon

  8. Departments of Medicine and Aging, University of Chieti “G. D’Annunzio”, Chieti, Italy

    Sante Pierdomenico, Francesco Cipollone & Andrea Mezzetti

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  1. Paolo Pauletto
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  2. Claudio Ferri
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Correspondence to Paolo Pauletto.

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Pauletto, P., Ferri, C., Volpe, M. et al. The Multicentre Atorvastatin Plaque Stabilisation (MAPS) Study. High Blood Press Cardiovasc Prev 10, 11–18 (2003). https://doi.org/10.2165/00151642-200310010-00004

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