Clinical Trials/NCT00620542

NCT00620542

Completed

Phase 3

Study of Coronary Atheroma by Intravascular Ultrasound: Effect of Rosuvastatin Versus Atorvastatin (SATURN)

AstraZeneca1 site in 1 country2,333 target enrollmentJanuary 2008

ConditionsCoronary Atherosclerosis

InterventionsRosuvastatin Atorvastatin

DrugsRosuvastatin Atorvastatin

Overview

Phase: Phase 3
Intervention: Rosuvastatin
Conditions: Coronary Atherosclerosis
Sponsor: AstraZeneca
Enrollment: 2333
Locations: 1
Primary Endpoint: Change From Baseline to End of Study (Week 104) in Percent Atheroma Volume (PAV)
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

January 2008

End Date

June 2011

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

AstraZeneca

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

Rosuvastatin 20 mg

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

Intervention: Rosuvastatin

Atorvastatin 40 mg

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

Intervention: Atorvastatin

Rosuvastatin 40 mg

Rosuvastatin 40 mg distributed in core 2-year study

Intervention: Rosuvastatin

Atorvastatin 80 mg

Atorvastatin 80 mg distributed in core 2-year study

Intervention: Atorvastatin

Outcomes

Primary Outcomes

Change From Baseline to End of Study (Week 104) in Percent Atheroma Volume (PAV)

Time Frame: End of study (Week 104)

Change in PAV computed as PAV(Week 104)-PAV(baseline) where PAV is calculated as: \[sum(EEMcsa-LUMENcsa)/sum EEMcsa\]\*100 where EEMcsa is the cross-sectional area of the external elastic membrane and LUMENcsa is the cross-sectional area of the lumen, as measured by intravascular ultrasound IVUS of a coronary artery in patients with CAD.

Secondary Outcomes

Numbers of Patients Showing Regression in PAV(End of study (Week 104))
Change From Baseline to End of Study (Week 104) in Total Atheroma Volume (TAV)(End of study (Week 104))
Numbers of Patients Showing Regression in TAV(End of study (Week 104))
Total Cholesterol Blood Level(104 weeks)
LDL-C Blood Level(104 weeks)
HDL-C Blood Level(104 weeks)
Triglycerides Blood Level(104 weeks)
Non-HDL-C Blood Level(104 weeks)
LDL-C/HDL-C Blood Level(104 weeks)
Total Cholesterol/HDL-C Blood Level(104 weeks)
Non-HDL-C/HDL-C Blood Level(104 weeks)
Apolipoprotein B Blood Level(104 weeks)
Apolipoprotein A-1 Blood Level(104 weeks)
Apoliprotein B/Apolipoprotein A-1 Blood Level(104 weeks)
VLDL-C During the 104 Week Treatment Period(104 weeks)