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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02418884
• Other study ID #: ESR-14-10098
• Status: Not yet recruiting
• Phase: Phase 4
• First received: March 30, 2015
• Last updated: April 13, 2015
• Start date: April 2015
• Est. completion date: March 2018

Study information

• Verified date: April 2015
• Source: Sir Run Run Shaw Hospital
• Contact: Guosheng Fu, MD/PhD
• Email: maoyihui_007[@]163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 122
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Arteriosclerosis
• Calcinosis
• Coronary Artery Disease
• Coronary Disease
• Diabetes Mellitus
• Myocardial Ischemia

Intervention

Drug:
• rosuvastatin
CAD patients with diabetes who confirmed CAC will receive rosuvastatin (20mg/d) therapy for 24 months.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sir Run Run Shaw Hospital

References & Publications (9)

Brandenburg VM, Kramann R, Koos R, Krüger T, Schurgers L, Mühlenbruch G, Hübner 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. — View 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. Erratum in: JAMA. 2015 Apr 7;313(13):1374. — View Citation

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. Epub 2004 Nov 22. — View Citation

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. Epub 2006 Jan 31. — View 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2007 Apr 26. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the Density Score of Coronary Artery Calcification in CAD patients with Diabetes Mellitus		24 months	No
Secondary	the level of serum sclerostin in CAD patients with diabetes mellitus		24months	No
Secondary	the volume score of CAC in CAD patients with diabetes mellitus		24 months	No