Study on the effects of rosuvastatin therapy on carotid plaque composition in asymptomatic patients enlisted to undergo carotid endarterectomy

INTERVENTION: Participants are randomly allocated to one or two groups. Those in the first group receive the lipid lowering treatment with rosuvastatin either at the usual dosage (10 mg/day). Those in the second group receive the lipid lowering treatment with rosuvastatin at a high dose (40 mg/day). The medication is administered once a day (at 8 p.m.), according to the drug indication, for 12 weeks in order to achieve a plasma level of LDL‐cholesterol <100 mg/dL at the time of endarterectomy (e.g. after 12 weeks of treatment). Although such a reduction was the minimum for keeping the patient, a higher reduction with rosuvastatin has been aimed at. Participants are followed up at 12 weeks with blood tests. CONDITION: Patients clinically asymptomatic patients enlisted to undergo elective carotid endarterectomy for reducing long‐term risk of stroke ; Nervous System Diseases ; Stroke PRIMARY OUTCOME: 1. MicroRNA expression in atherosclerotic plaques is measured using pre‐costumed; plates containing spotted microRNAs at week 12; 2. RNA and/or protein levels of metalloproteinases, cholesterol transporters and other mediators of plaque destabilization in atherosclerotic plaques are measured using the western blot analysis at week 12 ; 3. RNA and/or protein levels of potential target of deregulated microRNAs were measured using the western blot analysis at week 12 SECONDARY OUTCOME: 1. Plasma total cholesterol was measured using the electrochemiluminescence technology at 12 weeks; 2. Plasma low density lipoprotein (LDL) is measured using the electrochemiluminescence technology at 12 weeks; 3. Plasma high density lipoprotein (HDL) was measured using the electrochemiluminescence technology at 12 weeks; 4. Plasma triglycerides was measured using the electrochemiluminescence technology at 12 weeks; 5. Plasma glucose was measured using the electrochemiluminescence technology at 12 weeks; 6. Plasma markers of inflammation such as CRP, sVCAM‐1, sICAM‐1, soluble E‐selectin, soluble P‐selectin were measured using enzyme immunoassay at 12 weeks INCLUSION CRITERIA: 1. Clinical indication to the endarterectomy according to the international guidelines 2. Male or female patients between the ages of 50 and 85 years 3. LDL‐cholesterol >100 mg/dl 4. Extracranial high‐grade internal carotid artery (ICA) stenosis, near to carotid bifurcation 5. Patients have to be clinically stable at the time of randomization 6. High‐risk patients, as defined by one or more of the following criteria: 6.1. Prior history > 4 weeks of cerebrovascular accident (CVA) or transient ischemic attack (TIA) consistent with North American Symptomatic Carotid Endarterectomy Trial (NASCET) criteria or prior history of amaurosis fugax occurring at any time. 6.2. Baseline hsCRP >2 mg/L 6.3. Echolucent plaque [Grey Scale Median (GSM) <25] on carotid ultrasound