A Study to Evaluate the Efficacy and Safety of Rosuvastatin in the Treatment of the Carotid Atherosclerotic Plaques

Wei Liu

Status and phase

Unknown

Phase 4

Conditions

Carotid Atherosclerosis

Treatments

Drug: Rosuvastatin (5mg，10mg，20mg)

Drug: Rosuvastatin 5mg

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02532309

CJFH-20150203-CAP

Details and patient eligibility

About

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.

Full 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.

Enrollment

308 estimated patients

Sex

All

Ages

35 to 80 years old

Volunteers

No Healthy Volunteers

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.