The Multicenter Atorvastatin Plaque Stabilization (MAPS) Study

Not Applicable

Completed

• Conditions: Hypercholesterolemia; Symptomatic Carotid Stenosis; Indication for Carotid Endarterectomy
• Interventions: Drug: Atorvastatin - Cholestyramine - Sitosterol

• Registration Number: NCT01053065
• Lead Sponsor: University of Padova

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.

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 Timeline

• Status Verified: 2005-01
• Study First Submitted: 2010-01-20
• Study First Submitted QC: 2010-01-20
• Study First Posted: 2010-01-21
• Last Update Submitted: 2021-04-28
• Last Update Posted: 2021-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Atorvastatin 80 mg/day	Atorvastatin - Cholestyramine - Sitosterol	Arm composed of 20 patients, receiving atorvastatin 80 mg/day
Atorvastatin 10 mg/day	Atorvastatin - Cholestyramine - Sitosterol	Arm composed of 20 patients, receiving atorvastatin 10 mg/day
Cholestyramine - Sitosterol	Atorvastatin - Cholestyramine - Sitosterol	Arm composed of 20 patients receiving cholestyramine 8 g/day plus sitosterol 2.5 g/day

Primary Outcome Measures

Name	Time	Method
Changes in cellular composition of carotid plaque.	Three months

Trial Locations

Locations (3)

University of Chieti Medical School; 🇮🇹 Chieti, Italy

University of Padova Medical School - Treviso Branch; 🇮🇹 Treviso, Italy

University of Padova Medical School; 🇮🇹 Padova, Italy