Clinical trial NCT02418884: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Coronary Artery Disease
Lead sponsor: Sir Run Run Shaw Hospital
Sponsor class: OTHER
First posted: 2015-04-16
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: the Density Score of Coronary Artery Calcification in CAD patients with Diabetes Mellitus
timeFrame: 24 months
Secondary outcomes:
measure: the level of serum sclerostin in CAD patients with diabetes mellitus
timeFrame: 24months
measure: the volume score of CAC in CAD patients with diabetes mellitus
timeFrame: 24 months
Other outcomes:
Locations:
Study officials:
affiliation: Sir Run Run Shaw Hospital
name: Guosheng Fu, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Criqui MH, Denenberg JO, Ix JH, McClelland RL, Wassel CL, Rifkin DE, Carr JJ, Budoff MJ, Allison MA. Calcium density of coronary artery plaque and risk of incident cardiovascular events. JAMA. 2014 Jan 15;311(3):271-8. doi: 10.1001/jama.2013.282535.
citation: Koos R, Brandenburg V, Mahnken AH, Schneider R, Dohmen G, Autschbach R, Marx N, Kramann R. Sclerostin as a potential novel biomarker for aortic valve calcification: an in-vivo and ex-vivo study. J Heart Valve Dis. 2013 May;22(3):317-25.
citation: Brandenburg VM, Kramann R, Koos R, Kruger T, Schurgers L, Muhlenbruch G, Hubner S, Gladziwa U, Drechsler C, Ketteler M. Relationship between sclerostin and cardiovascular calcification in hemodialysis patients: a cross-sectional study. BMC Nephrol. 2013 Oct 10;14:219. doi: 10.1186/1471-2369-14-219.
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.