Trial | NCT02532309  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    rosuvastatin ...

  • Study Participants

    308
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 Started
Apr 30
2015
Primary Completion
Apr 30
2018
Anticipated
Last Update
Aug 28
2015
Estimate

Drug Rosuvastatin (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.

Drug Rosuvastatin 5mg

Rosuvastatin 5mg/day

Rosuvastatin dose adjustment Experimental

Rosuvastatin fixed dose Experimental

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.
No Results Posted