Status:
COMPLETED
A Study To Evaluate the Effect of Rosuvastatin On Intravascular Ultrasound-Derived Coronary Atheroma Burden (ASTEROID)
Lead Sponsor:
AstraZeneca
Conditions:
Coronary Arteriosclerosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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
Eligibility Criteria
Inclusion
- 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
- 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.
- \-
Key Trial Info
Start Date :
November 1 2002
Trial Type :
INTERVENTIONAL
End Date :
November 1 2005
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT00240318
Start Date
November 1 2002
End Date
November 1 2005
Last Update
November 19 2010
Active Locations (61)
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1
Research Site
Birmingham, Alabama, United States
2
Research Site
Los Angeles, California, United States
3
Research Site
San Francisco, California, United States
4
Research Site
Santa Rosa, California, United States