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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

308 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Carotid Atherosclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Rosuvastatin dose adjustment

Group Type EXPERIMENTAL

Rosuvastatin (5mg，10mg，20mg)

Intervention Type DRUG

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.

Rosuvastatin fixed dose

Group Type EXPERIMENTAL

Rosuvastatin 5mg

Intervention Type DRUG

Rosuvastatin 5mg/day

Interventions

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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.

Intervention Type DRUG

Rosuvastatin 5mg

Rosuvastatin 5mg/day

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

35 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No