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

August 26, 2015 updated by: Wei Liu

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

308

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China
        • Recruiting
        • China-Japan Friendship Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Liu Wei, Ph.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wei Liu

Collaborators

AstraZeneca
University of Washington
Beijing Clinstech-med consulting Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Anticipated)

April 1, 2018

Study Registration Dates

First Submitted

July 30, 2015

First Submitted That Met QC Criteria

August 21, 2015

First Posted (Estimate)

August 25, 2015

Study Record Updates

Last Update Posted (Estimate)

August 28, 2015

Last Update Submitted That Met QC Criteria

August 26, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CJFH-20150203-CAP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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