A Study To Evaluate the Effect of Rosuvastatin On Intravascular Ultrasound-Derived Coronary Atheroma Burden (ASTEROID)

November 18, 2010 updated by: AstraZeneca

A 104-Week, Open-label, Multi-centre, Phase IIIb Study Evaluating the Effect of Treatment With Rosuvastatin 40 mg on Atherosclerotic Disease as Measured by Intravascular Ultrasound and Quantitative Coronary Angiography in Subjects Undergoing Coronary Angiography Who Have Coronary Artery Disease

The purpose of this study is to see if 40 mg of rosuvastatin taken daily will reduce the atherosclerosis (fatty deposits) in your arteries

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

450

Phase

  • Phase 3

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

  • Australia
      • Auchenflower, Australia
        • Research Site
      • Clayton, Australia
        • Research Site
      • Heidelberg, Australia
        • Research Site
      • New Lambton, Australia
        • Research Site
  • Belgium
      • Aalst, Belgium
        • Research Site
      • Bruxelles, Belgium
        • Research Site
      • Edegem, Belgium
        • Research Site
      • Liege, Belgium
        • Research Site
  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
        • Research Site
    • Quebec
      • Montreal, Quebec, Canada
        • Research Site
      • Ste-Foy, Quebec, Canada
        • Research Site
  • France
      • Creteil, France
        • Research Site
      • Limoges, France
        • Research Site
      • Lyon, France
        • Research Site
      • Massy, France
        • Research Site
      • Melun, France
        • Research Site
      • Paris, France
        • Research Site
      • Pessac, France
        • Research Site
      • Toulouse, France
        • Research Site
  • Italy
      • Genova, Italy
        • Research Site
      • Milan, Italy
        • Research Site
      • Pavia, Italy
        • Research Site
      • Pisa, Italy
        • Research Site
      • Rome, Italy
        • Research Site
      • Siena, Italy
        • Research Site
      • Udine, Italy
        • Research Site
    • Milan
      • Rozzano, Milan, Italy
        • Research Site
    • Venezia
      • Mirano, Venezia, Italy
        • Research Site
  • Netherlands
      • Amsterdam, Netherlands
        • Research Site
      • Maastricht, Netherlands
        • Research Site
      • Nieuwegein, Netherlands
        • Research Site
      • Zwolle, Netherlands
        • Research Site
  • Spain
      • Barcelona, Spain
        • Research Site
      • Madrid, Spain
        • Research Site
      • Malaga, Spain
        • Research Site
      • Murias, Spain
        • Research Site
      • Valladolid, Spain
        • Research Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States
        • Research Site
    • California
      • Los Angeles, California, United States
        • Research Site
      • San Francisco, California, United States
        • Research Site
      • Santa Rosa, California, United States
        • Research Site
      • Stockton, California, United States
        • Research Site
    • Colorado
      • Denver, Colorado, United States
        • Research Site
    • Connecticut
      • Hartford, Connecticut, United States
        • Research Site
    • Florida
      • Atlantis, Florida, United States
        • Research Site
    • Illinois
      • Chicago, Illinois, United States
        • Research Site
      • Maywood, Illinois, United States
        • Research Site
    • Maine
      • Auburn, Maine, United States
        • Research Site
    • Maryland
      • Baltimore, Maryland, United States
        • Research Site
    • Michigan
      • Ann Arbor, Michigan, United States
        • Research Site
      • Petoskey, Michigan, United States
        • Research Site
    • Minnesota
      • Minneapolis, Minnesota, United States
        • Research Site
      • St. Paul, Minnesota, United States
        • Research Site
    • New York
      • Buffalo, New York, United States
        • Research Site
      • Valhalla, New York, United States
        • Research Site
      • Williamsville, New York, United States
        • Research Site
    • North Carolina
      • Chapel Hill, North Carolina, United States
        • Research Site
    • Ohio
      • Toledo, Ohio, United States
        • Research Site
    • Pennsylvania
      • Danville, Pennsylvania, United States
        • Research Site
    • Texas
      • Houston, Texas, United States
        • Research Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States
        • 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical indication for coronary catheterization. Target Coronary Artery: The target vessel must have .50% reduction in lumen diameter by angiographic visual estimation throughout a segment of at least 40 mm in length (the target segment) and the vessel must be large enough to accommodate the IVUS catheter. A lesion of up to 60% is permitted distal to the target segment. Side branches of the target (imaged) vessel may be narrowed up to 70% by visual estimation, provided the target segment contains no lesion greater than 50%.

Exclusion Criteria:

Use of lipid-lowering medication for more than 3 months within the previous 12 months. Longer periods of treatment are not permitted because of the potential effects of such therapy on coronary atherosclerosis. Subjects receiving treatment with a lipid-lowering medication within the past 4 weeks require a 4-week wash-out period following which a baseline lipid profile will be taken at visit 2.

Clinically significant heart disease which, in the opinion of the Principal Investigator (or designee), is likely to require coronary bypass surgery, cardiac transplantation, surgical repair and/or replacement during the course of the study.

-

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
to evaluate whether 2 years of treatment with 40 mg rosuvastatin results in regression of coronary artery atheroma burden via the total atheroma volume in the most diseased segment or the percent atheroma volume, as measured by IVUS

Secondary Outcome Measures

Outcome Measure
to evaluate whether treatment with rosuvastatin results in:
Regression of coronary artery atheroma burden, as assessed by TAV
Regression of coronary artery disease as measured by quantitative coronary angiography (QCA).
To evaluate the change in lipid and lipoprotein levels as assessed by percentage change from baseline.
To evaluate the safety of rosuvastatin

Collaborators and Investigators

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

Sponsor

AstraZeneca

Investigators

  • Study Director: AstraZeneca Crestor Medical Sciences Director, MD, AstraZeneca

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

November 1, 2002

Primary Completion (Actual)

November 1, 2005

Study Completion (Actual)

November 1, 2005

Study Registration Dates

First Submitted

October 16, 2005

First Submitted That Met QC Criteria

October 16, 2005

First Posted (Estimate)

October 18, 2005

Study Record Updates

Last Update Posted (Estimate)

November 19, 2010

Last Update Submitted That Met QC Criteria

November 18, 2010

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D3562C00076

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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