Back to resultsThe Impact of Rosuvastatin on the Density Score of Coronary Artery Calcification in CAD Patients With Diabetes Mellitus
Primary Purpose
Coronary Artery Disease
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
rosuvastatin
Sponsored by
About this trial
This is an interventional prevention trial for Coronary Artery Disease
Eligibility Criteria
Inclusion Criteria:
- Provision of informed consent prior to any study specific procedures
- Male and female adults aged 18-70 years old
- CHD patients without stent implantation determined by coronary angiography or coronary CT examination;
- Combined with type 2 diabetes: HbA1c≥6.5%, FPG≥7.0mmol/L, 2h blood glucose≥11.1mmol/L
- Patients who confirmed CAC(Agatston score ≥50,measured by 64 row spiral CT6)
Exclusion Criteria:
- CHD Patients plan to recieve coronary stenting implantation or coronary artery bypass grafting;
- Patients combined with severe pulmonary, liver and kidney dysfunction
- Classed as III-IV grade of New York Heart Association functional
- Pregnancy test was positive，lactation woman and in women of child-bearing potential not using appropriate contraceptive measures.
- Life expectancy within 24 months or less
- Patients combined valvular heart disease and cardiomyopathy
- Patients combined cancer
- Patients with atrial fibrillation
- Patients who is allergic to statins
- Patients with myopathy
- Patients with active liver disease
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
CAD+DM
Arm Description
Using self controlled study to validate the hypothesis that the treatment of rosuvastatin could increase the score of CAC density in CAD patients with diabetes mellitus.
Outcomes
Primary Outcome Measures
the Density Score of Coronary Artery Calcification in CAD patients with Diabetes Mellitus
Secondary Outcome Measures
the level of serum sclerostin in CAD patients with diabetes mellitus
the volume score of CAC in CAD patients with diabetes mellitus
Full Information
NCT ID
NCT02418884
First Posted
March 30, 2015
Last Updated
April 13, 2015
Sponsor
Sir Run Run Shaw Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02418884
Brief Title
The Impact of Rosuvastatin on the Density Score of Coronary Artery Calcification in CAD Patients With Diabetes Mellitus
Official Title
The Impact of Rosuvastatin on the Density Score of Coronary Artery Calcification in CAD Patients With Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Unknown status
Study Start Date
April 2015 (undefined)
Primary Completion Date
March 2018 (Anticipated)
Study Completion Date
March 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sir Run Run Shaw Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is designed to validate the hypothesis that the treatment of rosuvastatin could increase the score of Calcification of Coronary artery(CAC) density in coronary artery disease(CAD) patients with diabetes mellitus.CAD patients with diabetes who confirmed CAC will receive rosuvastatin (20mg/d) therapy for 24 months.
Detailed Description
Calcification of atherosclerotic plaque is a complicated and organic active process, which is one of the main pathologic features of atherosclerosis. Widely coverage of CAC is correlated with the greater likelihood of coronary events.With the increasing density of CAC, the risk of cardiovascular disease (CVD) declines.Some studies showed that the calcified plaque in stable CHD is denser.
Statins are widely used in the treatment of atherosclerotic cardiovascular disease. Treatment of statins may increase the density score of CAC, thus, promote the unstable atherosclerotic plaque to the stable plaque.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
122 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CAD+DM
Arm Type
Other
Arm Description
Using self controlled study to validate the hypothesis that the treatment of rosuvastatin could increase the score of CAC density in CAD patients with diabetes mellitus.
Intervention Type
Drug
Intervention Name(s)
rosuvastatin
Other Intervention Name(s)
Crestor
Intervention Description
CAD patients with diabetes who confirmed CAC will receive rosuvastatin (20mg/d) therapy for 24 months.
Primary Outcome Measure Information:
Title
the Density Score of Coronary Artery Calcification in CAD patients with Diabetes Mellitus
Time Frame
24 months
Secondary Outcome Measure Information:
Title
the level of serum sclerostin in CAD patients with diabetes mellitus
Time Frame
24months
Title
the volume score of CAC in CAD patients with diabetes mellitus
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Provision of informed consent prior to any study specific procedures
Male and female adults aged 18-70 years old
CHD patients without stent implantation determined by coronary angiography or coronary CT examination;
Combined with type 2 diabetes: HbA1c≥6.5%, FPG≥7.0mmol/L, 2h blood glucose≥11.1mmol/L
Patients who confirmed CAC(Agatston score ≥50,measured by 64 row spiral CT6)
Exclusion Criteria:
CHD Patients plan to recieve coronary stenting implantation or coronary artery bypass grafting;
Patients combined with severe pulmonary, liver and kidney dysfunction
Classed as III-IV grade of New York Heart Association functional
Pregnancy test was positive，lactation woman and in women of child-bearing potential not using appropriate contraceptive measures.
Life expectancy within 24 months or less
Patients combined valvular heart disease and cardiomyopathy
Patients combined cancer
Patients with atrial fibrillation
Patients who is allergic to statins
Patients with myopathy
Patients with active liver disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guosheng Fu, MD/PhD
Email
maoyihui_007@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Wenbin Zhang
Email
dream_flash_mx@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guosheng Fu, MD/PhD
Organizational Affiliation
Sir Run Run Shaw Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
10673250
Citation
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Results Reference
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Citation
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Results Reference
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PubMed Identifier
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Citation
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Citation
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Citation
Zhang W, Luan Y, Jin C, Xu S, Bi X, Zhao Y, Qiu F, Fu G, Wang M. The Impact of Rosuvastatin on the Density Score of Coronary Artery Calcification in Coronary Artery Disease Patients with Type 2 Diabetes Mellitus: Rationale and Design of RosCal Study. Clin Drug Investig. 2016 Dec;36(12):1023-1029. doi: 10.1007/s40261-016-0445-4.
Results Reference
derived
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The Impact of Rosuvastatin on the Density Score of Coronary Artery Calcification in CAD Patients With Diabetes Mellitus
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