CRESTOR Athero Imaging Head to Head IVUS Study (SATURN)

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Coronary Atherosclerosis

Treatments: Drug: Rosuvastatin; Drug: Atorvastatin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00620542

2007-004000-13

D356IC00001

Details and patient eligibility

About

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.

Enrollment: 2,333 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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2,333 participants in 4 patient groups

Rosuvastatin 20 mg

Experimental group

Description:

Rosuvastatin 20 mg distributed in 2-week run-in period

Treatment:

Drug: Rosuvastatin

Atorvastatin 40 mg

Active Comparator group

Description:

Atorvastatin 40 mg distributed in 2-week run-in period

Treatment:

Drug: Atorvastatin

Rosuvastatin 40 mg

Experimental group

Description:

Rosuvastatin 40 mg distributed in core 2-year study

Treatment:

Drug: Rosuvastatin

Atorvastatin 80 mg

Active Comparator group

Description:

Atorvastatin 80 mg distributed in core 2-year study

Treatment:

Drug: Atorvastatin