The Multicenter Atorvastatin Plaque Stabilization (MAPS) Study

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Padova; University of Padua
• Collaborators: Biomedical Foundation for Cardiovascular Research of Padova; Pfizer
• Treatments: Atorvastatin; Atorvastatin Calcium; Cholestyramine Resin; Gamma-sitosterol

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).