A randomized, multicenter, open-label, two-arm, parallel, phase III study to evaluate the efficacy and safety of nicotinic acid administered in combination with simvastatin for 6 months in comparison to simvastatin therapy alone in inhibiting the progression of atherosclerosis in patients with carotid arteries stenosis and dyslipidemia.

INTERVENTION: Product Name: Nicotinic acid, 500 mg, prolonged‐release tablet Pharmaceutical Form: Prolonged‐release tablet INN or Proposed INN: NICOTINIC ACID CAS Number: 59‐67‐6 Other descriptive name: NICOTINIC ACID Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 500‐ Product Name: Nicotinic acid, 750 mg, prolonged‐release tablet Pharmaceutical Form: Prolonged‐release tablet INN or Proposed INN: NICOTINIC ACID CAS Number: 59‐67‐6 Other descriptive name: NICOTINIC ACID Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 750‐ Product Name: Nicotinic acid, 1000 mg, prolonged‐release tablet Pharmaceutical Form: Prolonged‐release tablet INN or Proposed INN: NICOTINIC ACID CAS Number: 59‐67‐6 Other descriptive name: NICOTINIC ACID Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1000‐ Trade Name: Simvastatin Bluefish, 20 mg, film‐coated tablets Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: SIMVASTATIN CAS Number: 79902‐63‐9 Other descriptive name: SIMVASTATIN Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20‐ Trade Name: Simvastatin Blue?sh, 40 mg, ?lm‐coated tablets Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: SIMVASTATIN CAS Number: 79902‐63‐9 Other descriptive name: SIMVASTATIN Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 40‐ CONDITION: Inhibiting the progression of atherosclerosis in patients with carotid arteries stenosis and dyslipidemia. ; MedDRA version: 17.1 Level: PT Classification code 10007687 Term: Carotid artery stenosis System Organ Class: 10029205 ‐ Nervous system disorders ; MedDRA version: 17.1 Level: LLT Classification code 10058110 Term: Dyslipidemia System Organ Class: 100000004861 Therapeutic area: Diseases [C] ‐ Cardiovascular Diseases [C14] PRIMARY OUTCOME: Main Objective: To evaluate the efficacy of nicotinic acid used in combination with simvastatin at a dose of 20 mg daily in comparison to simvastatin administered at a dose of 40 mg daily in inhibiting the progression of atherosclerotic lesions after 6 months of therapy in patients with carotid artery stenosis and dyslipidemia. Primary end point(s): Change in common carotid arteries intima‐media thickness, assessed by ultrasound, after 6 months of the therapy. Secondary Objective: 1. To evaluate the influence of nicotinic acid used in combination with simvastatin at a dose of 20 mg daily on serum lipid fractions concentrations in comparison to simvastatin administered at a dose of 40 mg daily. ; 2. To evaluate the influence of nicotinic acid used in combination with simvastatin at a dose of 20 mg daily on frequency of major cardiovascular events in comparison to simvastatin administered at a dose of 40 mg daily.; Timepoint(s) of evaluation of this end point: 1. When subject abandonment of treatment.; 2. On the last medical examination. SECONDARY OUTCOME: Secondary end point(s): Groups will be compared for: ; 1. Change in LDL cholesterol level (LDL‐C);; 2. Change in HDL cholesterol level (HDL‐C);; 3. Change in non‐HDL cholesterol level (non‐HDL‐C);; 4. Change in total cholesterol (TC);; 5. Change in triglycerides level (TG); ; 6. Major cardiovascular events (composite endpoint): ; • brain stroke (ischemic, hemorrhagic, indefinite);; • transient (cerebral) ischemic attack (TIA);; • myocardial infarction;; • brain stroke mortality; ; • myocardial infarction mortality;; • sudden cardiac death; Timepoint(s) of evaluation of this end point: 1. When the study will be finished.; 2. When subject abandonment of treatment.; 3. On the last medical examination. INCLUSION CRITERIA: 1. Caucasian men and women aged = 18 years; 2. Stenosis of at least one internal carotid artery (ICA) < 70% assessed by carotid arteries ultrasound; 3. LDL‐C level > 100 mg / dL (> 2.5 mmol / L) despite taking simvastatin 20 mg daily or equivalent dose of another statin for at least last 28 days; 4. LDL‐C level > 115 mg / dl (> 3 mmol / L) in patients not taking any statin over the last 28 days; 5. Patients capable of understanding and following the study procedures; 6. Signing of Informed Consent Form to participate the study before the qualification procedures begin. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 70