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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02532309
Recruitment Status : Unknown
Verified August 2015 by Wei Liu, China-Japan Friendship Hospital.
Recruitment status was:  Recruiting
First Posted : August 25, 2015
Last Update Posted : August 28, 2015
Sponsor:
Collaborators:
University of Washington
AstraZeneca
Beijing Clinstech-med consulting Co., Ltd
Information provided by (Responsible Party):
Wei Liu, China-Japan Friendship Hospital

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : April 2015
Estimated Primary Completion Date : April 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Atherosclerosis

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




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Carotid Intima-Media Thickness(IMT) [ Time Frame: Up to 24 months ]
    Analysis of the corrlation between IMT and TPA in each treatment group.

  6. Incidence of Adverse Events [ Time Frame: Baseline to 24 months ]
    The categories and incidences of Adverse Events from the two treatment groups.

  7. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02532309


Contacts
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Contact: Cao Fei 86-10-56259183 frank.cao@clinstech-med.com

Locations
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China, Beijing
China-Japan Friendship Hospital Recruiting
Beijing, Beijing, China
Contact: Liu Wei, Ph.D       63483495@qq.com   
Contact: Jiao Jinsong, Professor       jiaojinsong@aliyun.com   
Principal Investigator: Liu Wei, Ph.D         
Sponsors and Collaborators
Wei Liu
University of Washington
AstraZeneca
Beijing Clinstech-med consulting Co., Ltd
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Responsible Party: Wei Liu, Attending Doctor, China-Japan Friendship Hospital
ClinicalTrials.gov Identifier: NCT02532309    
Other Study ID Numbers: CJFH-20150203-CAP
First Posted: August 25, 2015    Key Record Dates
Last Update Posted: August 28, 2015
Last Verified: August 2015
Keywords provided by Wei Liu, China-Japan Friendship Hospital:
Rosuvastatin
Carotid Atherosclerosis plaque
Crestor
Rosuvastatin calcium
Additional relevant MeSH terms:
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Carotid Artery Diseases
Atherosclerosis
Plaque, Atherosclerotic
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors