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

April 13, 2015 updated by: Guo Sheng Fu, Sir Run Run Shaw Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

122

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.
Drug: rosuvastatin
CAD patients with diabetes who confirmed CAC will receive rosuvastatin (20mg/d) therapy for 24 months.
Other Names:
  • Crestor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the Density Score of Coronary Artery Calcification in CAD patients with Diabetes Mellitus
Time Frame: 24 months
24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
the level of serum sclerostin in CAD patients with diabetes mellitus
Time Frame: 24months
24months
the volume score of CAC in CAD patients with diabetes mellitus
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sir Run Run Shaw Hospital

Investigators

  • Principal Investigator: Guosheng Fu, MD/PhD, Sir Run Run Shaw Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Anticipated)

March 1, 2018

Study Completion (Anticipated)

March 1, 2018

Study Registration Dates

First Submitted

March 30, 2015

First Submitted That Met QC Criteria

April 13, 2015

First Posted (Estimate)

April 16, 2015

Study Record Updates

Last Update Posted (Estimate)

April 16, 2015

Last Update Submitted That Met QC Criteria

April 13, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ESR-14-10098

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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