Clinical trial NCT02532309: A Study to Evaluate the Efficacy and Safety of Rosuvastatin in the Treatment of the Carotid Atherosclerotic Plaques
Official title: 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 Atherosclerotic Plaques
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Carotid Atherosclerosis
Keywords: Rosuvastatin
Carotid Atherosclerosis plaque
Crestor
Rosuvastatin calcium
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
Collaborators: name: University of Washington
name: AstraZeneca
name: Beijing Clinstech-med consulting Co., Ltd
First posted: 2015-08-25
Enrollment: 308
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Total Carotid Plaque Area
timeFrame: Up to 24 months
measure: Total Carotid Plaque Area
timeFrame: Up to 12 months
Secondary outcomes:
measure: Total Carotid Plaque Area
timeFrame: Baseline to 12 months and 24 months
measure: Carotid Intima-Media Thickness(IMT)
timeFrame: Baseline to 12 months and 24 months
measure: The level of Blood lipid
timeFrame: baseline and 1, 2, 3, 6, 12, 18, 24 months post-dose
measure: Low density lipoprotein-cholesterol (LDL-c)
timeFrame: Baseline to 12 months and 24 months
measure: Carotid Intima-Media Thickness(IMT)
timeFrame: Up to 24 months
measure: Incidence of Adverse Events
timeFrame: Baseline to 24 months
measure: Incidences of Major Adverse Cardiovascular and Cerebrovascular Events（MACCE）
timeFrame: Baseline to 24 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
Study officials:
References: