The Impact of Rosuvastatin on the Density Score of Coronary Artery Calcification in CAD Patients With Diabetes Mellitus

Phase 4

• Conditions: Coronary Artery Disease
• Interventions: Drug: rosuvastatin

• Registration Number: NCT02418884
• Lead Sponsor: Sir Run Run Shaw Hospital

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.

Study Timeline

• Study First Submitted: 2015-03-30
• Status Verified: 2015-04
• Study Start: 2015-04
• Study First Submitted QC: 2015-04-13
• Last Update Submitted: 2015-04-13
• Study First Posted: 2015-04-16
• Last Update Posted: 2015-04-16
• Primary Completion: 2018-03
• Study Completion: 2018-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 122

Inclusion Criteria

1. Provision of informed consent prior to any study specific procedures
2. Male and female adults aged 18-70 years old
3. CHD patients without stent implantation determined by coronary angiography or coronary CT examination;
4. Combined with type 2 diabetes: HbA1c≥6.5%, FPG≥7.0mmol/L, 2h blood glucose≥11.1mmol/L
5. Patients who confirmed CAC(Agatston score ≥50,measured by 64 row spiral CT6)

Exclusion Criteria

1. CHD Patients plan to recieve coronary stenting implantation or coronary artery bypass grafting;
2. Patients combined with severe pulmonary, liver and kidney dysfunction
3. Classed as III-IV grade of New York Heart Association functional
4. Pregnancy test was positive，lactation woman and in women of child-bearing potential not using appropriate contraceptive measures.
5. Life expectancy within 24 months or less
6. Patients combined valvular heart disease and cardiomyopathy
7. Patients combined cancer
8. Patients with atrial fibrillation
9. Patients who is allergic to statins
10. Patients with myopathy
11. Patients with active liver disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CAD+DM	rosuvastatin	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.

Primary Outcome Measures

Name	Time	Method
the Density Score of Coronary Artery Calcification in CAD patients with Diabetes Mellitus	24 months

Secondary Outcome Measures

Name	Time	Method
the level of serum sclerostin in CAD patients with diabetes mellitus	24months
the volume score of CAC in CAD patients with diabetes mellitus	24 months