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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wei Liu
• Collaborators: AstraZeneca; Beijing Clinstech-med consulting Co., Ltd; University of Washington
• Treatments: Rosuvastatin Calcium

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.