Carotid Atherosclerosis
Conditions
Keywords
Rosuvastatin, Carotid Atherosclerosis plaque, Crestor, Rosuvastatin calcium
Brief summary
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.
Detailed description
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.
Interventions
DRUGRosuvastatin (5mg，10mg，20mg)
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.
DRUGRosuvastatin 5mg
Rosuvastatin 5mg/day
Sponsors
University of Washington
AstraZeneca
Beijing Clinstech-med consulting Co., Ltd
Wei Liu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Subjects or legal guardian can understand and sign the written informed consent form; * LDL-C≥100mg/dl（2.6mmol/l）. * Subjects with carotid atherosclerotic non-calcified plaques determined by color Doppler ultrasound on carotid. ( Plaque defined as limited intima media thickness≥1.5mm, according to the procedure of vascular ultrasound examination in 2009 Chinese Journal of Ultrasonography ) * Subjects had not been treated with statins, or one had been treated with antihyperlipidemics no more than 3 months within 12 months prior to screening.
Exclusion criteria
* Subjects known to be allergic to the study medication, or any components . * Uncontrolled hypothyroidism defined as the systolic blood pressure(SBP) \>180 mmHg or the diastolic blood pressure(DBP) \>100 mmHg. * Concomitant with severe or frequent arrhythmia, such as Atrial Fibrillation, second or third degree Atrioventricular Block, Sick sinus Syndrome etc. * Alanine aminotransaminase (ALT) and /or Aspartate aminotransferase (AST) \>1.5×ULN (upper limit of normal). * Subjects with myopathies，or the value of Creatine kinase \>1.5×ULN (upper limit of normal). * Concomitant with chronic wasting diseases, whose life span was anticipated no longer than 2 years. * Pregnant or nursing woman, and subjects with a Pregnant plan during this study. * Cognitive impairment, which may affect obtaining informed consent and participating in the study procedures. * Unwilling to receive treatment or examinations outlined in protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Carotid Plaque Area | Up to 24 months | A comparison of the change in total Carotid Plaques area from the two treatment groups examined by color Doppler ultrasound. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Carotid Intima-Media Thickness(IMT) | Baseline to 12 months and 24 months | Changes of Carotid Intima-Media Thickness (IMT) in the two rosuvastatin treatment groups from baseline to 12 months and to 24 months. |
| The level of Blood lipid | baseline and 1, 2, 3, 6, 12, 18, 24 months post-dose | Changes from baseline in the level of Blood lipid from the two rosuvastatin treatment groups. |
| Total Carotid Plaque Area | Baseline to 12 months and 24 months | Changes from baseline in total Carotid Atherosclerosis Plaques (TPA) from the two rosuvastatin treatment groups from baseline at 12 months and 24 months. |
| Incidence of Adverse Events | Baseline to 24 months | The categories and incidences of Adverse Events from the two treatment groups. |
| Incidences of Major Adverse Cardiovascular and Cerebrovascular Events（MACCE） | Baseline to 24 months | Incidences of Major adverse cardiovascular and cerebrovascular events from the two rosuvastatin treatment groups. |
| Low density lipoprotein-cholesterol (LDL-c) | Baseline to 12 months and 24 months | Analysis of the corrlation between LDL-c and TPA from the two rosuvastatin treatment groups. |
Countries
China
Contacts
Primary ContactCao Fei
Outcome results
None listed