CRESTOR Athero Imaging Head to Head IVUS Study

Study Overview
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Brief Summary
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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.

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

Conditions
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Coronary Atherosclerosis

Intervention / Treatment
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* Drug: Rosuvastatin
* Drug: Atorvastatin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rosuvastatin 20 mg<br>Rosuvastatin 20 mg distributed in 2-week run-in period | Drug: Rosuvastatin<br>* capsule, oral, once daily<br>* Other names: Crestor;|
| Active Comparator: Atorvastatin 40 mg<br>Atorvastatin 40 mg distributed in 2-week run-in period | Drug: Atorvastatin<br>* capsule, oral, one daily<br>* Other names: Lipitor;|
| Experimental: Rosuvastatin 40 mg<br>Rosuvastatin 40 mg distributed in core 2-year study | Drug: Rosuvastatin<br>* capsule, oral, once daily<br>* Other names: Crestor;|
| Active Comparator: Atorvastatin 80 mg<br>Atorvastatin 80 mg distributed in core 2-year study | Drug: Atorvastatin<br>* capsule, oral, one daily<br>* Other names: Lipitor;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline to End of Study (Week 104) in Percent Atheroma Volume (PAV) | 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. | End of study (Week 104) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numbers of Patients Showing Regression in PAV | Regression defined as a change from baseline in PAV < 0 | End of study (Week 104) | 
| Change From Baseline to End of Study (Week 104) in Total Atheroma Volume (TAV) | Change in TAV, as measured by IVUS, computed as TAV(Week 104)-TAV(baseline) where TAV is the sum(EEMcsa-LUMENcsa)/n. n is the number of cross-sections measured. TAV for each patient is calculated as the average area of atheroma per cross-section multiplied by the median number of cross-sections measured for all patients in the analysis population. | End of study (Week 104) | 
| Numbers of Patients Showing Regression in TAV | Regression defined as a change from baseline in TAV < 0 | End of study (Week 104) | 
| Total Cholesterol Blood Level | Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation. | 104 weeks | 
| LDL-C Blood Level | Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation. | 104 weeks | 
| HDL-C Blood Level | Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation. | 104 weeks | 
| Triglycerides Blood Level | Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation. | 104 weeks | 
| Non-HDL-C Blood Level | Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation. | 104 weeks | 
| LDL-C/HDL-C Blood Level | Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation. | 104 weeks | 
| Total Cholesterol/HDL-C Blood Level | Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation. | 104 weeks | 
| Non-HDL-C/HDL-C Blood Level | Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation. | 104 weeks | 
| Apolipoprotein B Blood Level | Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation. | 104 weeks | 
| Apolipoprotein A-1 Blood Level | Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation. | 104 weeks | 
| Apoliprotein B/Apolipoprotein A-1 Blood Level | Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation. | 104 weeks | 
| VLDL-C During the 104 Week Treatment Period | Time-weighted average is calculated as the lipid value times the number of days since last lipid assessment, summed for all and divided by the number of days from Part B randomization to date of the last lipid evaluation. | 104 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary artery disease