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

Sponsor

Wei Liu (Other)

Overall Status

Unknown status

CT.gov ID

NCT02532309

Collaborator

University of Washington (Other), AstraZeneca (Industry), Beijing Clinstech-med consulting Co., Ltd (Other)

308

Enrollment

Location

Arms

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Carotid Atherosclerosis	Drug: Rosuvastatin (5mg，10mg，20mg) Drug: Rosuvastatin 5mg	Phase 4

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

308 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Apr 1, 2015

Anticipated Primary Completion Date :

Apr 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Rosuvastatin dose adjustment	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.
Experimental: Rosuvastatin fixed dose	Drug: Rosuvastatin 5mg Rosuvastatin 5mg/day

Arm

Intervention/Treatment

Experimental: Rosuvastatin dose adjustment

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.

Experimental: Rosuvastatin fixed dose

Drug: Rosuvastatin 5mg

Rosuvastatin 5mg/day

Outcome Measures

Primary Outcome Measures

Total Carotid Plaque Area [Up to 24 months]
A comparison of the change in total Carotid Plaques area from the two treatment groups examined by color Doppler ultrasound.
Total Carotid Plaque Area [Up to 12 months]
Reversal of total Carotid Atherosclerosis Plaques in the two rosuvastatin dose group at 12 months.

Secondary Outcome Measures

Total Carotid Plaque Area [Baseline to 12 months and 24 months]
Changes from baseline in total Carotid Atherosclerosis Plaques (TPA) from the two rosuvastatin treatment groups from baseline at 12 months and 24 months.
Carotid Intima-Media Thickness(IMT) [Baseline to 12 months and 24 months]
Changes of Carotid Intima-Media Thickness (IMT) in the two rosuvastatin treatment groups from baseline to 12 months and to 24 months.
The level of Blood lipid [baseline and 1, 2, 3, 6, 12, 18, 24 months post-dose]
Changes from baseline in the level of Blood lipid from the two rosuvastatin treatment groups.
Low density lipoprotein-cholesterol (LDL-c) [Baseline to 12 months and 24 months]
Analysis of the corrlation between LDL-c and TPA from the two rosuvastatin treatment groups.
Carotid Intima-Media Thickness(IMT) [Up to 24 months]
Analysis of the corrlation between IMT and TPA in each treatment group.
Incidence of Adverse Events [Baseline to 24 months]
The categories and incidences of Adverse Events from the two treatment groups.
Incidences of Major Adverse Cardiovascular and Cerebrovascular Events（MACCE） [Baseline to 24 months]
Incidences of Major adverse cardiovascular and cerebrovascular events from the two rosuvastatin treatment groups.

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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.