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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00620542
Registration number
NCT00620542
Ethics application status
Date submitted
6/02/2008
Date registered
21/02/2008
Date last updated
16/07/2012
Titles & IDs
Public title
CRESTOR Athero Imaging Head to Head IVUS Study
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Scientific title
Study of Coronary Atheroma by Intravascular Ultrasound: Effect of Rosuvastatin Versus Atorvastatin (SATURN)
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Secondary ID [1]
0
0
2007-004000-13
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Secondary ID [2]
0
0
D356IC00001
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Universal Trial Number (UTN)
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Trial acronym
SATURN
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Coronary Atherosclerosis
0
0
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Condition category
Condition code
Cardiovascular
0
0
0
0
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Diseases of the vasculature and circulation including the lymphatic system
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Cardiovascular
0
0
0
0
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Coronary heart disease
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Cardiovascular
0
0
0
0
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Rosuvastatin
Treatment: Drugs - Atorvastatin
Experimental: Rosuvastatin 20 mg - Rosuvastatin 20 mg distributed in 2-week run-in period
Active Comparator: Atorvastatin 40 mg - Atorvastatin 40 mg distributed in 2-week run-in period
Experimental: Rosuvastatin 40 mg - Rosuvastatin 40 mg distributed in core 2-year study
Active Comparator: Atorvastatin 80 mg - Atorvastatin 80 mg distributed in core 2-year study
Treatment: Drugs: Rosuvastatin
capsule, oral, once daily
Treatment: Drugs: Atorvastatin
capsule, oral, one daily
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Intervention code [1]
0
0
Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change From Baseline to End of Study (Week 104) in Percent Atheroma Volume (PAV)
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Assessment method [1]
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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.
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Timepoint [1]
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End of study (Week 104)
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Secondary outcome [1]
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0
Numbers of Patients Showing Regression in PAV
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Assessment method [1]
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Regression defined as a change from baseline in PAV < 0
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Timepoint [1]
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0
End of study (Week 104)
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Secondary outcome [2]
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0
Change From Baseline to End of Study (Week 104) in Total Atheroma Volume (TAV)
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Assessment method [2]
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0
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.
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Timepoint [2]
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0
End of study (Week 104)
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Secondary outcome [3]
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0
Numbers of Patients Showing Regression in TAV
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Assessment method [3]
0
0
Regression defined as a change from baseline in TAV < 0
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Timepoint [3]
0
0
End of study (Week 104)
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Secondary outcome [4]
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0
Total Cholesterol Blood Level
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Assessment method [4]
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0
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.
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Timepoint [4]
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0
104 weeks
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Secondary outcome [5]
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LDL-C Blood Level
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Assessment method [5]
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0
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.
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Timepoint [5]
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0
104 weeks
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Secondary outcome [6]
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0
HDL-C Blood Level
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Assessment method [6]
0
0
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.
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Timepoint [6]
0
0
104 weeks
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Secondary outcome [7]
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0
Triglycerides Blood Level
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Assessment method [7]
0
0
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.
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Timepoint [7]
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0
104 weeks
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Secondary outcome [8]
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0
Non-HDL-C Blood Level
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Assessment method [8]
0
0
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.
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Timepoint [8]
0
0
104 weeks
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Secondary outcome [9]
0
0
LDL-C/HDL-C Blood Level
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Assessment method [9]
0
0
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.
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Timepoint [9]
0
0
104 weeks
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Secondary outcome [10]
0
0
Total Cholesterol/HDL-C Blood Level
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Assessment method [10]
0
0
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.
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Timepoint [10]
0
0
104 weeks
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Secondary outcome [11]
0
0
Non-HDL-C/HDL-C Blood Level
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Assessment method [11]
0
0
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.
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Timepoint [11]
0
0
104 weeks
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Secondary outcome [12]
0
0
Apolipoprotein B Blood Level
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Assessment method [12]
0
0
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.
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Timepoint [12]
0
0
104 weeks
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Secondary outcome [13]
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0
Apolipoprotein A-1 Blood Level
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Assessment method [13]
0
0
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.
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Timepoint [13]
0
0
104 weeks
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Secondary outcome [14]
0
0
Apoliprotein B/Apolipoprotein A-1 Blood Level
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Assessment method [14]
0
0
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.
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Timepoint [14]
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0
104 weeks
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Secondary outcome [15]
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0
VLDL-C During the 104 Week Treatment Period
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Assessment method [15]
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0
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.
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Timepoint [15]
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0
104 weeks
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
75
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/01/2008
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/06/2011
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Sample size
Target
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Accrual to date
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Final
2333
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA
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Recruitment hospital [1]
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0
Research Site - Liverpool
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Recruitment hospital [2]
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Research Site - New Lambton Heights
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Recruitment hospital [3]
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Research Site - Chermside
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Recruitment hospital [4]
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Research Site - Adelaide
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Recruitment hospital [5]
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Research Site - Perth
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Recruitment postcode(s) [1]
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0
- Liverpool
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Recruitment postcode(s) [2]
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- New Lambton Heights
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Recruitment postcode(s) [3]
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- Chermside
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Recruitment postcode(s) [4]
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- Adelaide
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Recruitment postcode(s) [5]
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- Perth
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
Alabama
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0
0
United States of America
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State/province [2]
0
0
California
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Country [3]
0
0
United States of America
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State/province [3]
0
0
Colorado
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0
0
United States of America
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State/province [4]
0
0
Connecticut
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0
0
United States of America
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0
District of Columbia
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0
0
United States of America
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State/province [6]
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Florida
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Country [7]
0
0
United States of America
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State/province [7]
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0
Georgia
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Country [8]
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0
United States of America
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State/province [8]
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0
Indiana
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United States of America
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State/province [9]
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Iowa
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United States of America
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State/province [10]
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Kentucky
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United States of America
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Louisiana
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United States of America
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Maryland
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United States of America
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Michigan
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United States of America
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Minnesota
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United States of America
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Missouri
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United States of America
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Montana
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United States of America
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Nebraska
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United States of America
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New Jersey
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United States of America
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New Mexico
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United States of America
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New York
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United States of America
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North Carolina
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North Dakota
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Ohio
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Oklahoma
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Oregon
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Argentina
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Buenos Aires
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Argentina
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Brussels
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Belgium
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Charleroi
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Belgium
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Genk
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Belgium
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Leuven
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Brazil
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ES
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Brazil
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GO
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Brazil
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MG
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Brazil
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MT
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Brazil
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PR
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Brazil
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SP
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Alberta
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Canada
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British Columbia
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Canada
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Manitoba
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Canada
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New Brunswick
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Canada
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Nova Scotia
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Canada
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Canada
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Saskatchewan
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France
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Besancon
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France
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Bron
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France
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Creteil
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France
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Le Plessis-robinson
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France
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Marseille
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France
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Pessac
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France
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Quincy Sous Senart
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France
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Strasbourg
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France
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Toulouse
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Hungary
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Budapest
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Hungary
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Szged
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Italy
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AR
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Italy
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Milano
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Italy
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MI
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Italy
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PR
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Italy
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SI
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Italy
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UD
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0
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Italy
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Novara
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Italy
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Roma
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Mexico
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Jalisco
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Mexico
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Aguascalientes
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Mexico
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D.F
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Mexico
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Monterrey
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Mexico
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Puebla
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Mexico
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Queretaro
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Mexico
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Tijuana
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Netherlands
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Alkmaar
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Netherlands
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Amsterdam
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Netherlands
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Breda
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Netherlands
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Eindhoven
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Netherlands
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Enschede
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Leeuwarden
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Nieuwegein
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Netherlands
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Nijmegen
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Netherlands
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Rotterdam
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Netherlands
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Zwolle
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Poland
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Bialystok
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Poland
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Katowice
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Poland
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Kedzierzyn Kozle
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Poland
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Krakow
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Poland
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Lodz
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Poland
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Poznan
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Poland
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Warszawa
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Poland
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Zabrze
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0
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Russian Federation
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Moscow Region
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Russian Federation
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Moscow
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Russian Federation
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Saint Petersburg
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Russian Federation
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State/province [103]
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Tomsk
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Country [104]
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Russian Federation
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State/province [104]
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Tumen
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Country [105]
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Spain
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State/province [105]
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Andalucia
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Country [106]
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Spain
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State/province [106]
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Asturias
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Country [107]
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Spain
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State/province [107]
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Cataluna
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Country [108]
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Spain
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State/province [108]
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Comunidad de Madrid
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Country [109]
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Spain
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State/province [109]
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Comunidad Valenciana
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
AstraZeneca
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Other collaborator category [1]
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Other
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Name [1]
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The Cleveland Clinic
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00620542
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Public notes
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Contacts
Principal investigator
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Stephen J Nicholls, MBBS, PhD
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Cleveland Clinic Foundation, Cardiovascular Medicine
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00620542
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