NCT02418884

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
122

participants targeted

Target at P25-P50 for phase_4 coronary-artery-disease

Timeline
Completed

Started Apr 2015

Typical duration for phase_4 coronary-artery-disease

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2015

Completed
2 days until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 16, 2015

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

April 16, 2015

Status Verified

April 1, 2015

Enrollment Period

2.9 years

First QC Date

March 30, 2015

Last Update Submit

April 13, 2015

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • the Density Score of Coronary Artery Calcification in CAD patients with Diabetes Mellitus

    24 months

Secondary Outcomes (2)

  • 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

Study Arms (1)

CAD+DM

OTHER

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.

Drug: rosuvastatin

Interventions

rosuvastatinDRUG

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

Also known as: Crestor
CAD+DM

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (10)

  • 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.

    PMID: 10673250BACKGROUND

  • 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.

    PMID: 12633805BACKGROUND

  • 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.

    PMID: 12563143BACKGROUND

  • 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.

    PMID: 15557374BACKGROUND

  • 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.

    PMID: 16449511BACKGROUND

  • 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.

    PMID: 17560880BACKGROUND

  • 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.

    PMID: 24247483BACKGROUND

  • 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.

    PMID: 24151757BACKGROUND

  • 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.

    PMID: 24112318BACKGROUND

  • 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.

    PMID: 27541380DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Guosheng Fu, MD/PhD

    Sir Run Run Shaw Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Guosheng Fu, MD/PhD

CONTACT

maoyihui_007@163.com

Wenbin Zhang

CONTACT

dream_flash_mx@126.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD/PhD

Study Record Dates

First Submitted

March 30, 2015

First Posted

April 16, 2015

Study Start

April 1, 2015

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

April 16, 2015

Record last verified: 2015-04