The Multicenter Atorvastatin Plaque Stabilization (MAPS) Study

Hypercholesterolemia Clinical Trial

— MAPS  

Official title:

The Multicenter Atorvastatin Plaque Stabilization (MAPS) Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01053065
• Other study ID #: MAPS
• Status: Completed
• Phase: N/A

Study information

• Verified date: January 2005
• Source: University of Padova
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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).

Related Conditions & MeSH terms

• Carotid Stenosis
• Hypercholesterolemia
• Indication for Carotid Endarterectomy
• Symptomatic Carotid Stenosis

Intervention

Drug:
• Atorvastatin - Cholestyramine - Sitosterol

Locations

Country	Name	City	State
Italy	University of Chieti Medical School	Chieti
Italy	University of Padova Medical School	Padova
Italy	University of Padova Medical School - Treviso Branch	Treviso

Sponsors (3)

Lead Sponsor	Collaborator
University of Padova	Biomedical Foundation for Cardiovascular Research of Padova, Pfizer

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in cellular composition of carotid plaque.		Three months