The Impact of Rosuvastatin on the Density Score of Coronary Artery Calcification in CAD Patients With Diabetes Mellitus
NCT ID: NCT02418884
Last Updated: 2015-04-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
122 participants
INTERVENTIONAL
2015-04-30
2018-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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CAD+DM
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.
rosuvastatin
CAD patients with diabetes who confirmed CAC will receive rosuvastatin (20mg/d) therapy for 24 months.
Interventions
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rosuvastatin
CAD patients with diabetes who confirmed CAC will receive rosuvastatin (20mg/d) therapy for 24 months.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
70 Years
ALL
No
Sponsors
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Sir Run Run Shaw Hospital
OTHER
Responsible Party
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Guo Sheng Fu
MD/PhD
Principal Investigators
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Guosheng Fu, MD/PhD
Role: PRINCIPAL_INVESTIGATOR
Sir Run Run Shaw Hospital
Central Contacts
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References
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Schoenhagen P, Ziada KM, Kapadia SR, Crowe TD, Nissen SE, Tuzcu EM. Extent and direction of arterial remodeling in stable versus unstable coronary syndromes : an intravascular ultrasound study. Circulation. 2000 Feb 15;101(6):598-603. doi: 10.1161/01.cir.101.6.598.
Leber AW, Knez A, White CW, Becker A, von Ziegler F, Muehling O, Becker C, Reiser M, Steinbeck G, Boekstegers P. Composition of coronary atherosclerotic plaques in patients with acute myocardial infarction and stable angina pectoris determined by contrast-enhanced multislice computed tomography. Am J Cardiol. 2003 Mar 15;91(6):714-8. doi: 10.1016/s0002-9149(02)03411-2. No abstract available.
Shemesh J, Apter S, Itzchak Y, Motro M. Coronary calcification compared in patients with acute versus in those with chronic coronary events by using dual-sector spiral CT. Radiology. 2003 Feb;226(2):483-8. doi: 10.1148/radiol.2262011903.
Ehara S, Kobayashi Y, Yoshiyama M, Shimada K, Shimada Y, Fukuda D, Nakamura Y, Yamashita H, Yamagishi H, Takeuchi K, Naruko T, Haze K, Becker AE, Yoshikawa J, Ueda M. Spotty calcification typifies the culprit plaque in patients with acute myocardial infarction: an intravascular ultrasound study. Circulation. 2004 Nov 30;110(22):3424-9. doi: 10.1161/01.CIR.0000148131.41425.E9. Epub 2004 Nov 22.
Houslay ES, Cowell SJ, Prescott RJ, Reid J, Burton J, Northridge DB, Boon NA, Newby DE; Scottish Aortic Stenosis and Lipid Lowering Therapy, Impact on Regression trial Investigators. Progressive coronary calcification despite intensive lipid-lowering treatment: a randomised controlled trial. Heart. 2006 Sep;92(9):1207-12. doi: 10.1136/hrt.2005.080929. Epub 2006 Jan 31.
Terry JG, Carr JJ, Kouba EO, Davis DH, Menon L, Bender K, Chandler ET, Morgan T, Crouse JR 3rd. Effect of simvastatin (80 mg) on coronary and abdominal aortic arterial calcium (from the coronary artery calcification treatment with zocor [CATZ] study). Am J Cardiol. 2007 Jun 15;99(12):1714-7. doi: 10.1016/j.amjcard.2007.01.060. Epub 2007 Apr 26.
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.
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.
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.
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.
Other Identifiers
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ESR-14-10098
Identifier Type: -
Identifier Source: org_study_id
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