Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000394943
Ethics application status
Not yet submitted
Date submitted
10/04/2011
Date registered
14/04/2011
Date last updated
14/04/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of combination of rosuvastatin and fenofibrate and metoprolol on the coronary atheroma plaque progression detected by multi-detector spiral computed tomography
Scientific title
The combination of rosuvastatin and fenofibrate and metoprolol can impede coronary atheroma plaque progression detected by multi-detector spiral computed tomography
Secondary ID [1] 259883 0
Nil
Universal Trial Number (UTN)
U1111-1120-6615
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
coronary artery disease 265476 0
hyperlipidemia 265641 0
Condition category
Condition code
Cardiovascular 265629 265629 0 0
Coronary heart disease
Metabolic and Endocrine 265772 265772 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There are 3 intervention arms in this study.
rosuvastatin 10 mg/day plus fenofibrate 80 mg/day plus metoprolol 50mg /day for 6 months
rosuvastatin 10 mg/day plus fenofibrate 80 mg/day for 6 months
rosuvastatin 10 mg/day plus metoprolol 50mg/day for 6 months.
All of the drugs are taken as oral capsules or tablets.
Intervention code [1] 264306 0
Treatment: Drugs
Comparator / control treatment
Lipid lowering agents are not given. They are only give some health advice such as nutrition advices through the consulation with physicians and through health information booklet distributed monthly, this procedure will be continue for 6 months.
Control group
Active

Outcomes
Primary outcome [1] 262415 0
the change of atheroma plaque volume is assessed by coronary computed tomography angiography
Timepoint [1] 262415 0
6 month
Primary outcome [2] 262416 0
the change of CT attenuation value is assessed by coronary computed tomography angiography
Timepoint [2] 262416 0
6 month
Primary outcome [3] 262423 0
major cardiovascular events(death, myocardial infarction, coronary revascularization, rehospitalization driven by symptom)
Timepoint [3] 262423 0
6 month
Secondary outcome [1] 273746 0
the change of percent atheroma volume( PAV) is assessed by coronary computed tomography angiography
Timepoint [1] 273746 0
6 month
Secondary outcome [2] 273747 0
the change of coronary artery calcification score is assessed by multidetector computed tomography (MDCT) without contrast enhancement
Timepoint [2] 273747 0
6 month
Secondary outcome [3] 273761 0
the change of coronary artery remodling index is assessed by coronary computed tomography angiography
Timepoint [3] 273761 0
6 month
Secondary outcome [4] 273762 0
the change of coronary artery area stenosis is assessed by coronary computed tomography angiography
Timepoint [4] 273762 0
6 month
Secondary outcome [5] 273763 0
the change of coronary artery minimal lumen area( MLA) is assessed by coronary computed tomography angiography
Timepoint [5] 273763 0
6 month
Secondary outcome [6] 273764 0
the change of low-density lipoprotein cholesterol (LDL-C) is measured by standard enzymatic methods.
Timepoint [6] 273764 0
1 month, 3month, 6 month
Secondary outcome [7] 273765 0
the change of high-density lipoprotein cholesterol (HDL-C) is measured by standard enzymatic methods.
Timepoint [7] 273765 0
1 month, 3month, 6 month
Secondary outcome [8] 273766 0
the change of triglyceride (TG) is measured by standard enzymatic methods.
Timepoint [8] 273766 0
1 month, 3month, 6 month
Secondary outcome [9] 273767 0
the change of hs-CRP is assessed by ELISA method.
Timepoint [9] 273767 0
1 month, 3month, 6 month
Secondary outcome [10] 273768 0
the change of lipoprotein-associated phospholipase A2(Lp-PLA2) is assessed by ELISA method.
Timepoint [10] 273768 0
1 month, 3month, 6 month
Secondary outcome [11] 273769 0
the change of liver function is assessed by blood serum assay.
Timepoint [11] 273769 0
1 month, 3month, 6 month
Secondary outcome [12] 273770 0
the change of creatine kinase is assessed by blood serum assay.
Timepoint [12] 273770 0
1 month, 3month, 6 month

Eligibility
Key inclusion criteria
1.no chest pain or atypical chest pain
2.mild to moderate coronary atheroma plaque by multidetector computed tomography (MDCT)
3. diameter narrowing is less than 50%
4. low-density lipoprotein cholesterol(LDL-C)>100mg/dl, triglyceride(TG)>150 mg/dL
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
known coronary artery disease; previous coronary revascularization; signs or symptoms suggesting ischemia and coronary revascularization needed in a short time; current lipid-lowering pharmacotherapy; known genetic form of dyslipidemia; creatinine > 1.5 mg/dL; ALT or AST>40u/L; fasting serum TG> 500 mg/dL; inability to perform MDCT; uncontrolled hypertension; decompensated heart failure (class IV); known pregnancy; combined condition decreasing life expectancy; heart rate<60 beats/min; sick sinus syndrome; atrioventricular block over 2 degree type 2

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Eligible subjects who agree to participate will undergo baseline laboratory evaluation, measurements of serum lipoproteins, fast serum glucose, hs-CRP, lipoprotein-associated phospholipase A2(Lp-PLA2), liver and kidney function tests, creatine kinase, and a baseline CT study, including coronary artery calcium (CAC) measurements and a contrast- enhanced coronary computed tomography angiography (CCTA) examination. Subjects then will be randomly assigned in a 1:1:1:1 ratio either to a combination of rosuvastatin 10 mg plus fenofibrate 80 mg plus metoprolol 50mg or rosuvastatin 10 mg plus fenofibrate 80 mg or rosuvastatin 10 mg plus metoprolol 50mg or blank control group. Allocation is randomised by computer. Treatment assignment and patients check result will be blind to the CCTA operator and data analyst, and the whole survey will continue for 6 months.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Using statistical software(SPSS 13.0) to generate a series randomized number and allocate the eligible subjects to the four groups respectively.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
520
Accrual to date
Final
Recruitment outside Australia
Country [1] 3321 0
China
State/province [1] 3321 0
Beijing

Funding & Sponsors
Funding source category [1] 264832 0
Government body
Name [1] 264832 0
Ministry of Science and Technology of the Peoples Republic of China
Country [1] 264832 0
China
Primary sponsor type
University
Name
Peking University Health Science Center
Address
Xueyuan Road, Haidian district, Beijing, 100083
Country
China
Secondary sponsor category [1] 263938 0
Hospital
Name [1] 263938 0
Chinese PLA General Hospital
Address [1] 263938 0
No.28, Fuxing road, Beijing, 100853
Country [1] 263938 0
China
Other collaborator category [1] 251913 0
Individual
Name [1] 251913 0
Huaiyu Qiao
Address [1] 251913 0
Department of cardiology
Chinese PLA general hospital
No.28, Fuxing Road
Beijing
100853
Country [1] 251913 0
China
Other collaborator category [2] 251914 0
Individual
Name [2] 251914 0
Bin He
Address [2] 251914 0
Department of cardiology
Chinese PLA general hospital
No.28, Fuxing Road
Beijing
100853
Country [2] 251914 0
China
Other collaborator category [3] 251915 0
Individual
Name [3] 251915 0
Suyang Zhang
Address [3] 251915 0
Department of cardiology
Chinese PLA general hospital
No.28, Fuxing Road
Beijing
100853
Country [3] 251915 0
China
Other collaborator category [4] 251916 0
Individual
Name [4] 251916 0
Qinhua Jin
Address [4] 251916 0
Department of cardiology
Chinese PLA general hospital
No.28, Fuxing Road
Beijing
100853
Country [4] 251916 0
China
Other collaborator category [5] 251917 0
Individual
Name [5] 251917 0
Zhenghong Fu
Address [5] 251917 0
Department of cardiology
Chinese PLA general hospital
No.28, Fuxing Road
Beijing
100853
Country [5] 251917 0
China

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 266751 0
Chinese PLA General Hospital Ethics Committee
Ethics committee address [1] 266751 0
Ethics committee country [1] 266751 0
China
Date submitted for ethics approval [1] 266751 0
12/04/2011
Approval date [1] 266751 0
Ethics approval number [1] 266751 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32410 0
Address 32410 0
Country 32410 0
Phone 32410 0
Fax 32410 0
Email 32410 0
Contact person for public queries
Name 15657 0
Luyue Gai
Address 15657 0
the Cardiology Department
Chinese PLA general hospital
No.28, Fuxing Road
100853
Beijing
Country 15657 0
China
Phone 15657 0
086-010-55499011
Fax 15657 0
Email 15657 0
[email protected]
Contact person for scientific queries
Name 6585 0
Luyue Gai
Address 6585 0
the Cardiology Department
Chinese PLA general hospital
No.28, Fuxing Road
100853
Beijing
Country 6585 0
China
Phone 6585 0
086-010-55499011
Fax 6585 0
Email 6585 0
[email protected]

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No Supporting Document Provided



Results publications and other study-related documents

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