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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

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Abstract

Introduction

More and more evidence suggests that the density of calcification plays an important role in the plaque stability. However, few studies have investigated the statin treatment on the density of plaque calcification in patients with both coronary artery disease (CAD) and type 2 diabetes mellitus.

Methods

One hundred and twenty-two CAD patients with type 2 diabetes with confirmed coronary artery calcification (CAC) will be recruited consecutively in a 12-month period. These patients will receive rosuvastatin (20 mg/day) therapy in the next 24 months. Blood tests and adverse events will be collected at routine follow-up of 1, 3, 6, 12, 18 and 24 months. The primary endpoint will be the change of CAC density score measured by coronary CT angiography after 24 months’ treatment of rosuvastatin (20 mg/day) compared with baseline. The secondary endpoints will be the change of serum sclerostin and the effect on the volume score of CAC in those patients.

Results

We expect that rosuvastatin could both increase the density of CAC to improve plaque stability and up-regulate serum sclerostin, which would suggest the underlying mechanism of the plaque stabilization by a statin.

Conclusion

This study would be the first to demonstrate the impact of rosuvastatin on the density score of coronary artery calcification in CAD patients with type 2 diabetes.

This study has been registered in ClinicalTrials.gov (NCT02418884).

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Acknowledgments

This study was supported by Natural Science Foundation of Zhejiang Province (No. LQ14H020002), Health Department Foundation of Zhejiang Province (No. 201466184), Natural Science Foundation of Zhejiang Province (No. LQ16H020002), National Natural Science Foundation of China (No. 81500212) and AstraZeneca (No. ESR-14-10098).

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Author notes

    Authors and Affiliations

    1. Department of Cardiology, Biomedical Research (Therapy) Center, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, 310016, Zhejiang, China

      Wenbin Zhang, Yi Luan, Chongying Jin, Shengjie Xu, Xukun Bi, Yanbo Zhao, Fuyu Qiu, Guosheng Fu & Min Wang

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    1. Wenbin Zhang
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    2. Yi Luan
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    Correspondence to Guosheng Fu or Min Wang.

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    Conflict of interest

    Wenbin Zhang, Yi Luan, Chongying Jin, Shengjie Xu, Xukun Bi, Yanbo Zhao, Fuyu Qiu, Guosheng Fu and Min Wang have no conflict of interest.

    Ethical approval

    Approval of the protocols and informed consent forms were obtained from the institutional ethics committee of Sir Run Run Shaw Hospital of Zhejiang University and Zhejiang Hospital, and written informed consents were obtained from all patients. This study has been registered in ClinicalTrials.gov (NCT02418884).

    Additional information

    W. Zhang and Y. Luan contributed equally to this work.

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    Zhang, W., Luan, Y., Jin, C. et al. 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 36, 1023–1029 (2016). https://doi.org/10.1007/s40261-016-0445-4

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    • DOI: https://doi.org/10.1007/s40261-016-0445-4

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