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

Primary Purpose

Carotid Atherosclerosis

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Rosuvastatin (5mg，10mg，20mg)
Rosuvastatin 5mg
Sponsored by
Wei Liu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carotid Atherosclerosis focused on measuring Rosuvastatin, Carotid Atherosclerosis plaque, Crestor, Rosuvastatin calcium

Eligibility Criteria

35 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • China-Japan Friendship HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Rosuvastatin dose adjustment

Rosuvastatin fixed dose

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Total Carotid Plaque Area
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)
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
Changes from baseline in the level of Blood lipid from the two rosuvastatin treatment groups.
Low density lipoprotein-cholesterol (LDL-c)
Analysis of the corrlation between LDL-c and TPA from the two rosuvastatin treatment groups.
Carotid Intima-Media Thickness(IMT)
Analysis of the corrlation between IMT and TPA in each treatment group.
Incidence of Adverse Events
The categories and incidences of Adverse Events from the two treatment groups.
Incidences of Major Adverse Cardiovascular and Cerebrovascular Events（MACCE）
Incidences of Major adverse cardiovascular and cerebrovascular events from the two rosuvastatin treatment groups.

Full Information

First Posted
July 30, 2015
Last Updated
August 26, 2015
Sponsor
Wei Liu
Collaborators
University of Washington, AstraZeneca, Beijing Clinstech-med consulting Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT02532309
Brief Title
A Study to Evaluate the Efficacy and Safety of Rosuvastatin in the Treatment of the Carotid Atherosclerotic Plaques
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 Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Unknown status
Study Start Date
April 2015 (undefined)
Primary Completion Date
April 2018 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Wei Liu
Collaborators
University of Washington, AstraZeneca, Beijing Clinstech-med consulting Co., Ltd

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carotid Atherosclerosis
Keywords
Rosuvastatin, Carotid Atherosclerosis plaque, Crestor, Rosuvastatin calcium

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
308 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Rosuvastatin dose adjustment
Arm Type
Experimental
Arm Title
Rosuvastatin fixed dose
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin (5mg，10mg，20mg)
Intervention Description
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
Intervention Name(s)
Rosuvastatin 5mg
Intervention Description
Rosuvastatin 5mg/day
Primary Outcome Measure Information:
Title
Total Carotid Plaque Area
Description
A comparison of the change in total Carotid Plaques area from the two treatment groups examined by color Doppler ultrasound.
Time Frame
Up to 24 months
Title
Total Carotid Plaque Area
Description
Reversal of total Carotid Atherosclerosis Plaques in the two rosuvastatin dose group at 12 months.
Time Frame
Up to 12 months
Secondary Outcome Measure Information:
Title
Total Carotid Plaque Area
Description
Changes from baseline in total Carotid Atherosclerosis Plaques (TPA) from the two rosuvastatin treatment groups from baseline at 12 months and 24 months.
Time Frame
Baseline to 12 months and 24 months
Title
Carotid Intima-Media Thickness(IMT)
Description
Changes of Carotid Intima-Media Thickness (IMT) in the two rosuvastatin treatment groups from baseline to 12 months and to 24 months.
Time Frame
Baseline to 12 months and 24 months
Title
The level of Blood lipid
Description
Changes from baseline in the level of Blood lipid from the two rosuvastatin treatment groups.
Time Frame
baseline and 1, 2, 3, 6, 12, 18, 24 months post-dose
Title
Low density lipoprotein-cholesterol (LDL-c)
Description
Analysis of the corrlation between LDL-c and TPA from the two rosuvastatin treatment groups.
Time Frame
Baseline to 12 months and 24 months
Title
Carotid Intima-Media Thickness(IMT)
Description
Analysis of the corrlation between IMT and TPA in each treatment group.
Time Frame
Up to 24 months
Title
Incidence of Adverse Events
Description
The categories and incidences of Adverse Events from the two treatment groups.
Time Frame
Baseline to 24 months
Title
Incidences of Major Adverse Cardiovascular and Cerebrovascular Events（MACCE）
Description
Incidences of Major adverse cardiovascular and cerebrovascular events from the two rosuvastatin treatment groups.
Time Frame
Baseline to 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cao Fei
Phone
86-10-56259183
Email
frank.cao@clinstech-med.com
Facility Information:
Facility Name
China-Japan Friendship Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liu Wei, Ph.D
Email
63483495@qq.com
First Name & Middle Initial & Last Name & Degree
Jiao Jinsong, Professor
Email
jiaojinsong@aliyun.com
First Name & Middle Initial & Last Name & Degree
Liu Wei, Ph.D

12. IPD Sharing Statement

Learn more about this trial

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

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