CClinicalTrials.gg
CompletedNCT00240318Updated Nov 19, 2010

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

A Phase 3 interventional study of Rosuvastatin calcium in Coronary Arteriosclerosis, sponsored by AstraZeneca. Completed at 61 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-11-19.

Sponsored by AstraZeneca · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
450
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Coronary Arteriosclerosis

Keywords

  • Coronary Artery Disease
03

In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's enrollment of 450 is above the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.

-

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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
450 participants

Interventions

  • DrugRosuvastatin calcium

    Also known as: Crestor

06

What researchers measure

Primary outcomes

  1. 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 outcomes

  1. to evaluate whether treatment with rosuvastatin results in:

  2. Regression of coronary artery atheroma burden, as assessed by TAV

  3. Regression of coronary artery disease as measured by quantitative coronary angiography (QCA).

  4. To evaluate the change in lipid and lipoprotein levels as assessed by percentage change from baseline.

  5. To evaluate the safety of rosuvastatin

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Study locations

61 sites
  • Research Site
    Birmingham, Alabama, United States
  • Research Site
    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
    Denver, Colorado, United States
  • Research Site
    Hartford, Connecticut, United States
  • Research Site
    Atlantis, Florida, United States
  • Research Site
    Chicago, Illinois, United States
  • Research Site
    Maywood, Illinois, United States
  • Research Site
    Auburn, Maine, United States
  • Research Site
    Baltimore, Maryland, United States
  • Research Site
    Ann Arbor, Michigan, United States
  • Research Site
    Petoskey, Michigan, United States
  • Research Site
    Minneapolis, Minnesota, United States
  • Research Site
    St. Paul, Minnesota, United States
  • Research Site
    Buffalo, New York, United States
  • Research Site
    Valhalla, New York, United States
  • Research Site
    Williamsville, New York, United States
  • Research Site
    Chapel Hill, North Carolina, United States
  • Research Site
    Toledo, Ohio, United States
  • Research Site
    Danville, Pennsylvania, United States
  • Research Site
    Houston, Texas, United States
  • Research Site
    Milwaukee, Wisconsin, United States
  • Research Site
    Auchenflower, Australia
  • Research Site
    Clayton, Australia
  • Research Site
    Heidelberg, Australia
  • Research Site
    New Lambton, Australia
  • Research Site
    Aalst, Belgium
  • Research Site
    Bruxelles, Belgium
  • Research Site
    Edegem, Belgium
  • Research Site
    Liege, Belgium
  • Research Site
    Halifax, Nova Scotia, Canada
  • Research Site
    Montreal, Quebec, Canada
  • Research Site
    Ste-Foy, Quebec, Canada
  • Research Site
    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
    Rozzano, Milan, Italy
  • Research Site
    Mirano, Venezia, Italy
  • Research Site
    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
    Amsterdam, Netherlands
  • Research Site
    Maastricht, Netherlands
  • Research Site
    Nieuwegein, Netherlands
  • Research Site
    Zwolle, Netherlands
  • Research Site
    Barcelona, Spain
  • Research Site
    Madrid, Spain
  • Research Site
    Malaga, Spain
  • Research Site
    Murias, Spain
  • Research Site
    Valladolid, Spain
08

References and documents

Publications

  • Nissen SE, Nicholls SJ, Sipahi I, Libby P, Raichlen JS, Ballantyne CM, Davignon J, Erbel R, Fruchart JC, Tardif JC, Schoenhagen P, Crowe T, Cain V, Wolski K, Goormastic M, Tuzcu EM; ASTEROID Investigators. Effect of very high-intensity statin therapy on regression of coronary atherosclerosis: the ASTEROID trial. JAMA. 2006 Apr 5;295(13):1556-65. doi: 10.1001/jama.295.13.jpc60002. Epub 2006 Mar 13. PubMed 16533939 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 19, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00240318
Lead sponsor
AstraZeneca
First posted
Oct 18, 2005
Start date
Nov 2002
Primary completion
Nov 2005
Completion
Nov 2005
Last update
Nov 19, 2010

Study contacts

AstraZeneca Crestor Medical Sciences Director, MD
study director · AstraZeneca
View the source record on ClinicalTrials.gov ↗

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