The Multicenter Atorvastatin Plaque Stabilization (MAPS) Study
Overview
- Phase
- Not Applicable
- Intervention
- Atorvastatin - Cholestyramine - Sitosterol
- Conditions
- Symptomatic Carotid Stenosis
- Sponsor
- University of Padova
- Enrollment
- 60
- Locations
- 3
- Primary Endpoint
- Changes in cellular composition of carotid plaque.
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Eligibility 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).
Arms & Interventions
Atorvastatin 10 mg/day
Arm composed of 20 patients, receiving atorvastatin 10 mg/day
Intervention: Atorvastatin - Cholestyramine - Sitosterol
Atorvastatin 80 mg/day
Arm composed of 20 patients, receiving atorvastatin 80 mg/day
Intervention: Atorvastatin - Cholestyramine - Sitosterol
Cholestyramine - Sitosterol
Arm composed of 20 patients receiving cholestyramine 8 g/day plus sitosterol 2.5 g/day
Intervention: Atorvastatin - Cholestyramine - Sitosterol
Outcomes
Primary Outcomes
Changes in cellular composition of carotid plaque.
Time Frame: Three months