This is a 2-year, open-label, randomized study to evaluate the efficacy of Rosuvastatin dosing adjustment by LDL-C level compared to that of 5mg maintenance dose in chinese patients with Carotid Atherosclerosis.
This will be a 2-year, randomized, open-label, prospective, parallel-group study. It only be held in China-Japan Friendship Hospital. Subjects with Carotid Atherosclerosis Plaques who meet all inclusion and none of the exclusion criteria will be randomized in a 1:1 ratio to receive treatment of rosuvastatin (5 mg, 10mg, 20mg) dosing adjustment by LDL-c level or fixed dose 5 mg. The study will consist of two phases: the Screening/Baseline period(-1to week 0)and the Follow-up period(0 to month 24). The follow-up period will comprise seven visits.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
308
Rosuvastatin dose adjusted by LDL-c level( If LDL-C\>1.1mmol/L and \<1.8mmol/L, administrated as 5mg/day.If LDL-C ≥1.8mmol/L, adjusted every 4 weeks as 5mg,10mg,20mg.
Rosuvastatin 5mg/day
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China
RECRUITINGTotal Carotid Plaque Area
A comparison of the change in total Carotid Plaques area from the two treatment groups examined by color Doppler ultrasound.
Time frame: Up to 24 months
Total Carotid Plaque Area
Reversal of total Carotid Atherosclerosis Plaques in the two rosuvastatin dose group at 12 months.
Time frame: Up to 12 months
Total Carotid Plaque Area
Changes from baseline in total Carotid Atherosclerosis Plaques (TPA) from the two rosuvastatin treatment groups from baseline at 12 months and 24 months.
Time frame: Baseline to 12 months and 24 months
Carotid Intima-Media Thickness(IMT)
Changes of Carotid Intima-Media Thickness (IMT) in the two rosuvastatin treatment groups from baseline to 12 months and to 24 months.
Time frame: Baseline to 12 months and 24 months
The level of Blood lipid
Changes from baseline in the level of Blood lipid from the two rosuvastatin treatment groups.
Time frame: baseline and 1, 2, 3, 6, 12, 18, 24 months post-dose
Low density lipoprotein-cholesterol (LDL-c)
Analysis of the corrlation between LDL-c and TPA from the two rosuvastatin treatment groups.
Time frame: Baseline to 12 months and 24 months
Carotid Intima-Media Thickness(IMT)
Analysis of the corrlation between IMT and TPA in each treatment group.
Time frame: Up to 24 months
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Incidence of Adverse Events
The categories and incidences of Adverse Events from the two treatment groups.
Time frame: Baseline to 24 months
Incidences of Major Adverse Cardiovascular and Cerebrovascular Events(MACCE)
Incidences of Major adverse cardiovascular and cerebrovascular events from the two rosuvastatin treatment groups.
Time frame: Baseline to 24 months