Official Title: “Study of Coronary Atheroma by Intravascular Ultrasound: Effect of Rosuvastatin Versus Atorvastatin (SATURN)”

A 104-week, randomized, double-blink, parallel group, multi-center Phase IIIb study comparing the effects of treatment with rosuvastatin 40 mg or atorvastatin 80mg on atherosclerotic disease burden as measured by intravascular ultrasound in patients with coronary artery disease.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study

Study Primary Completion Date: December 2010

Intervention(s) in this Clinical Trial

• Drug: Rosuvastatin
  • capsule, oral, once daily
• Drug: Atorvastatin
  • capsule, oral, one daily

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Active Comparator: 2

Primary Measures

• To compare the effects of rosuvastatin with atorvastatin on the percent atheroma volume (PAV), as measured by IVUS
  • Time Frame: pre and post treatment
    Safety Issue?: No

Secondary Measures

• Regression of percent atheroma volume (PAV) , as measured by IVUS
  • Time Frame: pre and post treatment
    Safety Issue?: No

Inclusion Criteria:

• Clinical indication for coronary angiography
• Angiographic evidence of 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 Criteria:

• 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: AstraZeneca

Overall Clinical Trial Officials and Contacts

Stephen J Nicholls, MBBS, PhD Principal Investigator Cleveland Clinic Foundation, Cardiovascular Medicine  

Overall Contact: AstraZeneca Clinical Study Information 800-236-9933 information.center@astrazeneca.com

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00620542

Study ID Number: D356IC00001

ClinicalTrials.gov Identifier: NCT00620542

Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration