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

Condition(s) targeted: Coronary Arteriosclerosis

Intervention: Rosuvastatin calcium (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
AstraZeneca Crestor Medical Sciences Director, MD, Study Director, Affiliation: AstraZeneca

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

Official title: 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

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Primary outcome: 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:

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

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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, 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, Genova, Italy

Research Site, Milan, Italy

Research Site, Pavia, Italy

Research Site, Pisa, Italy

Research Site, Rome, 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

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, Rozzano, Milan, Italy

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, Halifax, Nova Scotia, Canada

Research Site, Toledo, Ohio, United States

Research Site, Danville, Pennsylvania, United States

Research Site, Montreal, Quebec, Canada

Research Site, Ste-Foy, Quebec, Canada

Research Site, Houston, Texas, United States

Research Site, Mirano, Venezia, Italy

Research Site, Milwaukee, Wisconsin, United States

Starting date: November 2002
Last updated: May 2, 2006