The Multicenter Atorvastatin Plaque Stabilization (MAPS) Study
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Atorvastatin 10 mg/day Arm composed of 20 patients, receiving atorvastatin 10 mg/day |
Drug: Atorvastatin - Cholestyramine - Sitosterol
|
| Active Comparator: Atorvastatin 80 mg/day Arm composed of 20 patients, receiving atorvastatin 80 mg/day |
Drug: Atorvastatin - Cholestyramine - Sitosterol
|
| Active Comparator: Cholestyramine - Sitosterol Arm composed of 20 patients receiving cholestyramine 8 g/day plus sitosterol 2.5 g/day |
Drug: Atorvastatin - Cholestyramine - Sitosterol
|
Outcome Measures
Primary Outcome Measures
- Changes in cellular composition of carotid plaque. [Three months]
Eligibility Criteria
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).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Chieti Medical School | Chieti | Italy | 66100 | |
| 2 | University of Padova Medical School | Padova | Italy | 35128 | |
| 3 | University of Padova Medical School - Treviso Branch | Treviso | Italy | 31100 |
Sponsors and Collaborators
- University of Padova
- Biomedical Foundation for Cardiovascular Research of Padova
- Pfizer
Investigators
- Principal Investigator: Paolo Pauletto, MD, University of Padova - Italy
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- MAPS