CRESTOR Athero Imaging Head to Head IVUS Study

Completed · Phase 3

Conditions studied: Coronary Atherosclerosis

In brief

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 as measured by intravascular ultrasound in patients with coronary artery disease.

Key facts

Study ID

NCT00620542

Run by

AstraZeneca

People needed

2333

Starts

2008-01-01

Expected to finish

2011-06-01

Last updated by the study team

2012-07-16

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Research Site — Los Angeles, California, United States
• Research Site — Mountain View, California, United States
• Research Site — Sacramento, California, United States
• Research Site — San Diego, California, United States
• Research Site — Santa Rosa, California, United States
• Research Site — Torrance, California, United States
• Research Site — Boulder, Colorado, United States
• Research Site — Greeley, Colorado, United States
• Research Site — Loveland, Colorado, United States
• Research Site — Farmington, Connecticut, United States
• Research Site — Washington D.C., District of Columbia, United States
• Research Site — Clearwater, Florida, United States
• Research Site — Fort Lauderdale, Florida, United States
• Research Site — Jacksonville, Florida, United States
• Research Site — Melbourne, Florida, United States
• Research Site — Miami, Florida, United States
• Research Site — Orlando, Florida, United States
• Research Site — Sarasota, Florida, United States
• Research Site — Tampa, Florida, United States
• Research Site — Winter Haven, Florida, United States
• Research Site — Atlanta, Georgia, United States
• Research Site — Augusta, Georgia, United States
• Research Site — Elkhart, Indiana, United States
• Research Site — Hammond, Indiana, United States
• Research Site — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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