Status:
COMPLETED
CRESTOR Athero Imaging Head to Head IVUS Study
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
The Cleveland Clinic
Conditions:
Coronary Atherosclerosis
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
A 104-week, randomized, double-blind, parallel group, multi-center Phase IIIb study comparing the effects of treatment with rosuvastatin 40 mg or atorvastatin 80 mg on atherosclerotic disease burden a...
Eligibility Criteria
Inclusion
- Clinical indication for coronary angiography
- Angiographic evidence of Coronary Artery Disease (CAD), as defined by at least 1 lesion in a native coronary artery that has \>20% reduction in lumen diameter by visual estimation
- Left main coronary artery must have \<=50% reduction in lumen diameter by visual estimation
- LDL-C \>100 mg/dL (2.6 mmol/L) for patients with no statin therapy in the past 4 weeks; LDL-C \>80mg/dL (2.08mmol/L) for patients on therapy in the past 4 weeks
Exclusion
- Use of certain 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.
- Patients who have symptoms consistent with moderate or greater severity of Congestive Heart Failure (CHF).
- 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 :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
2333 Patients enrolled
Trial Details
Trial ID
NCT00620542
Start Date
January 1 2008
End Date
June 1 2011
Last Update
July 16 2012
Active Locations (195)
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1
Research Site
Huntsville, Alabama, United States
2
Research Site
Los Angeles, California, United States
3
Research Site
Mountain View, California, United States
4
Research Site
Sacramento, California, United States