Rosuvastatin in the Long-term Treatment of Hypercholesterolaemic Subjects With Coronary Heart Disease

August 29, 2011 updated by: AstraZeneca

A Study to Evaluate the Efficacy and Safety of Rosuvastatin in the Long-term Treatment of Hypercholesterolaemic Subjects With Coronary Heart Disease as Measured by Intravascular Ultrasonography

The primary objective of this study is to evaluate that 76 weeks of treatment with rosuvastatin calcium 2.5-20 mg results in no progression of coronary artery atherosclerotic volume as measured by intravascular ultrasonography (IVUS) imaging in hypercholesterolaemic subjects with coronary heart disease (CHD).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

214

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 Locations

  • Japan
      • Gifu, Japan
        • Research Site
      • Hamada, Japan
        • Research Site
      • Hiroshima, Japan
        • Research Site
      • Ichinomiya, Japan
        • Research Site
      • Inba-mura, Japan
        • Research Site
      • Izumi, Japan
        • Research Site
      • Izumisano, Japan
        • Research Site
      • Izumo, Japan
        • Research Site
      • Kagoshima, Japan
        • Research Site
      • Kanazawa, Japan
        • Research Site
      • Kasuga, Japan
        • Research Site
      • Kobe, Japan
        • Research Site
      • Komaki, Japan
        • Research Site
      • Konan-cho, Japan
        • Research Site
      • Kumamoto, Japan
        • Research Site
      • Kurume, Japan
        • Research Site
      • Kyoto, Japan
        • Research Site
      • Omiya, Japan
        • Research Site
      • Osaka, Japan
        • Research Site
      • Sapporo, Japan
        • Research Site
      • Shinjo, Japan
        • Research Site
      • Shunan, Japan
        • Research Site
      • Suita, Japan
        • Research Site
      • Tokyo, Japan
        • Research Site
      • Ube, Japan
        • Research Site
      • Yamaguchi, Japan
        • Research Site
      • Yokohama, Japan
        • Research Site

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

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Signed written informed consent,
  • 20 to 75 years old,
  • Plan to undergo coronary angiography (CAG) or Percutaneous coronary intervention (PCI) and LDL-C ≥ 140 mg/dL (untreated patients) or LDL-C ≥ 100 mg/dL (treated patients)

Exclusion Criteria:

  • Acute myocardial infarction within 72 hours after the onset,
  • Heart failure of New York Heart Association (NYHA) Class III or above,
  • Serious arrhythmia,
  • Being treated with LDL-apheresis
  • History of serious reaction or hypersensitivity to other HMG-CoA reductase inhibitors.

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: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline (Before the Start of Rosuvastatin Treatment) to Week 76 in the Plaque Volume (PV)
Time Frame: Baseline and 76 weeks
Plaque volume will be assessed by volumetric analysis with the echoPlaque2 system (Indec Systems Inc). Baseline and follow-up IVUS images will be reviewed side-by-side on a display, and the target segment selected. The target segment to be monitored will be determined in a non-PCI site (>5 mm proximal or distal to the PCI site) with a reproducible index such as side branches, calcifications, or stent edges.
Baseline and 76 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline to Week 76 in Plaque Volume (PV) in the Target Lesion
Time Frame: Baseline - 76Weeks
Target Lesion indicates Coronary plaque composition of culprit lesions.
Baseline - 76Weeks
Percent Change From Baseline to Specified Measurement Time Points in Low-density Lipoprotein （LDL-C）
Time Frame: Baseline - 76Weeks
Baseline - 76Weeks
Percent Change in High-sensitivity C-reactive Protein (HS-CRP) From Baseline to Specified Measurement Time Points
Time Frame: Baseline - 76Weeks
Baseline - 76Weeks

Collaborators and Investigators

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

Sponsor

AstraZeneca

Collaborators

Shionogi

Investigators

  • Principal Investigator: Masunori Matsuzaki, MD, Yamaguchi University 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

October 1, 2005

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

May 22, 2006

First Submitted That Met QC Criteria

May 22, 2006

First Posted (Estimate)

May 24, 2006

Study Record Updates

Last Update Posted (Estimate)

August 31, 2011

Last Update Submitted That Met QC Criteria

August 29, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D3565L00002
  • 0407E1841

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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