The Multicenter Atorvastatin Plaque Stabilization (MAPS) Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Symptomatic Carotid Stenosis Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Dyslipidemias Hypercholesterolemia Hyperlipidemias Indication for Carotid Endarterectomy Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Chieti Medical School, Chieti, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Atorvastatin - Cholestyramine - Sitosterol

Drug

Primary outcomes

Changes in cellular composition of carotid plaque.

Time frame: Three months

Sponsors and collaborators

Lead sponsor

University of Padova

Other

Collaborators

Biomedical Foundation for Cardiovascular Research of Padova
Pfizer

Registry information

Acronym: MAPS

Important dates

First posted: Jan 21, 2010
Registry last updated: Apr 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed