A Study To Evaluate the Effect of Rosuvastatin On Intravascular Ultrasound-Derived Coronary Atheroma Burden (ASTEROID)
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
1 other identifier
interventional
450
8 countries
61
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Nov 2002
Typical duration for phase_3
61 active sites
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
Study Start
First participant enrolled
November 1, 2002
CompletedFirst Submitted
Initial submission to the registry
October 16, 2005
CompletedFirst Posted
Study publicly available on registry
October 18, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2005
CompletedNovember 19, 2010
November 1, 2010
3 years
October 16, 2005
November 18, 2010
Conditions
Keywords
Outcome Measures
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 (5)
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
Interventions
Eligibility Criteria
You may qualify if:
- 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%.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (61)
Research Site
Birmingham, Alabama, United States
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Los Angeles, California, United States
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San Francisco, California, United States
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Santa Rosa, California, United States
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Stockton, California, United States
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Denver, Colorado, United States
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Hartford, Connecticut, United States
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Atlantis, Florida, United States
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Chicago, Illinois, United States
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Maywood, Illinois, United States
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Auburn, Maine, United States
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Baltimore, Maryland, United States
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Ann Arbor, Michigan, United States
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Petoskey, Michigan, United States
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Minneapolis, Minnesota, United States
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Saint Paul, Minnesota, United States
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Buffalo, New York, United States
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Valhalla, New York, United States
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Williamsville, New York, United States
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Chapel Hill, North Carolina, United States
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Toledo, Ohio, United States
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Danville, Pennsylvania, United States
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Houston, Texas, United States
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Milwaukee, Wisconsin, United States
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Auchenflower, Australia
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Clayton, Australia
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Heidelberg, Australia
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New Lambton, Australia
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Aalst, Belgium
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Brussels, Belgium
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Edegem, Belgium
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Liège, Belgium
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Halifax, Nova Scotia, Canada
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Montreal, Quebec, Canada
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Ste-Foy, Quebec, Canada
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Créteil, France
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Limoges, France
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Lyon, France
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Massy, France
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Melun, France
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Paris, France
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Pessac, France
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Toulouse, France
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Rozzano, Milan, Italy
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Mirano, Venezia, Italy
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Genova, Italy
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Milan, Italy
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Pavia, Italy
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Pisa, Italy
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Rome, Italy
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Siena, Italy
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Udine, Italy
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Amsterdam, Netherlands
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Maastricht, Netherlands
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Nieuwegein, Netherlands
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Zwolle, Netherlands
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Barcelona, Spain
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Madrid, Spain
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Málaga, Spain
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Murias, Spain
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Valladolid, Spain
Related Publications (1)
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.
PMID: 16533939RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
AstraZeneca Crestor Medical Sciences Director, MD
AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 16, 2005
First Posted
October 18, 2005
Study Start
November 1, 2002
Primary Completion
November 1, 2005
Study Completion
November 1, 2005
Last Updated
November 19, 2010
Record last verified: 2010-11