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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Scientific title
Study of Coronary Atheroma by Intravascular Ultrasound: Effect of Rosuvastatin Versus Atorvastatin (SATURN)
Secondary ID [1] 0 0
2007-004000-13
Secondary ID [2] 0 0
D356IC00001
Universal Trial Number (UTN)
Trial acronym
SATURN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Atherosclerosis 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
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

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline to End of Study (Week 104) in Percent Atheroma Volume (PAV)
Timepoint [1] 0 0
End of study (Week 104)
Secondary outcome [1] 0 0
Numbers of Patients Showing Regression in PAV
Timepoint [1] 0 0
End of study (Week 104)
Secondary outcome [2] 0 0
Change From Baseline to End of Study (Week 104) in Total Atheroma Volume (TAV)
Timepoint [2] 0 0
End of study (Week 104)
Secondary outcome [3] 0 0
Numbers of Patients Showing Regression in TAV
Timepoint [3] 0 0
End of study (Week 104)
Secondary outcome [4] 0 0
Total Cholesterol Blood Level
Timepoint [4] 0 0
104 weeks
Secondary outcome [5] 0 0
LDL-C Blood Level
Timepoint [5] 0 0
104 weeks
Secondary outcome [6] 0 0
HDL-C Blood Level
Timepoint [6] 0 0
104 weeks
Secondary outcome [7] 0 0
Triglycerides Blood Level
Timepoint [7] 0 0
104 weeks
Secondary outcome [8] 0 0
Non-HDL-C Blood Level
Timepoint [8] 0 0
104 weeks
Secondary outcome [9] 0 0
LDL-C/HDL-C Blood Level
Timepoint [9] 0 0
104 weeks
Secondary outcome [10] 0 0
Total Cholesterol/HDL-C Blood Level
Timepoint [10] 0 0
104 weeks
Secondary outcome [11] 0 0
Non-HDL-C/HDL-C Blood Level
Timepoint [11] 0 0
104 weeks
Secondary outcome [12] 0 0
Apolipoprotein B Blood Level
Timepoint [12] 0 0
104 weeks
Secondary outcome [13] 0 0
Apolipoprotein A-1 Blood Level
Timepoint [13] 0 0
104 weeks
Secondary outcome [14] 0 0
Apoliprotein B/Apolipoprotein A-1 Blood Level
Timepoint [14] 0 0
104 weeks
Secondary outcome [15] 0 0
VLDL-C During the 104 Week Treatment Period
Timepoint [15] 0 0
104 weeks

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
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA
Recruitment hospital [1] 0 0
Research Site - Liverpool
Recruitment hospital [2] 0 0
Research Site - New Lambton Heights
Recruitment hospital [3] 0 0
Research Site - Chermside
Recruitment hospital [4] 0 0
Research Site - Adelaide
Recruitment hospital [5] 0 0
Research Site - Perth
Recruitment postcode(s) [1] 0 0
- Liverpool
Recruitment postcode(s) [2] 0 0
- New Lambton Heights
Recruitment postcode(s) [3] 0 0
- Chermside
Recruitment postcode(s) [4] 0 0
- Adelaide
Recruitment postcode(s) [5] 0 0
- Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
District of Columbia
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
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United States of America
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Iowa
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United States of America
State/province [10] 0 0
Kentucky
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United States of America
State/province [11] 0 0
Louisiana
Country [12] 0 0
United States of America
State/province [12] 0 0
Maryland
Country [13] 0 0
United States of America
State/province [13] 0 0
Michigan
Country [14] 0 0
United States of America
State/province [14] 0 0
Minnesota
Country [15] 0 0
United States of America
State/province [15] 0 0
Missouri
Country [16] 0 0
United States of America
State/province [16] 0 0
Montana
Country [17] 0 0
United States of America
State/province [17] 0 0
Nebraska
Country [18] 0 0
United States of America
State/province [18] 0 0
New Jersey
Country [19] 0 0
United States of America
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New Mexico
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United States of America
State/province [20] 0 0
New York
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North Carolina
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State/province [22] 0 0
North Dakota
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Ohio
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Oklahoma
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Oregon
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Pennsylvania
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South Carolina
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State/province [28] 0 0
Tennessee
Country [29] 0 0
United States of America
State/province [29] 0 0
Texas
Country [30] 0 0
United States of America
State/province [30] 0 0
Virginia
Country [31] 0 0
United States of America
State/province [31] 0 0
Washington
Country [32] 0 0
Argentina
State/province [32] 0 0
Buenos Aires
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Argentina
State/province [33] 0 0
Santa Fe-argentina
Country [34] 0 0
Argentina
State/province [34] 0 0
Cordoba
Country [35] 0 0
Argentina
State/province [35] 0 0
Corrientes
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Belgium
State/province [36] 0 0
Aalst
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Belgium
State/province [37] 0 0
Brugge
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Belgium
State/province [38] 0 0
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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Canada
State/province [48] 0 0
Alberta
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Canada
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British Columbia
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Canada
State/province [50] 0 0
Manitoba
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Canada
State/province [51] 0 0
New Brunswick
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Canada
State/province [52] 0 0
Nova Scotia
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Canada
State/province [53] 0 0
Ontario
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Canada
State/province [54] 0 0
Quebec
Country [55] 0 0
Canada
State/province [55] 0 0
Saskatchewan
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France
State/province [56] 0 0
Besancon
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France
State/province [57] 0 0
Bron
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France
State/province [58] 0 0
Creteil
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France
State/province [59] 0 0
Le Plessis-robinson
Country [60] 0 0
France
State/province [60] 0 0
Marseille
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France
State/province [61] 0 0
Pessac
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France
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Quincy Sous Senart
Country [63] 0 0
France
State/province [63] 0 0
Strasbourg
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France
State/province [64] 0 0
Toulouse
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Hungary
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Budapest
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Hungary
State/province [66] 0 0
Szged
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Italy
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AR
Country [68] 0 0
Italy
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Milano
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Italy
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MI
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Italy
State/province [70] 0 0
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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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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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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Netherlands
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Leeuwarden
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Netherlands
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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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Krakow
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Lodz
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Poznan
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Poland
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Warszawa
Country [99] 0 0
Poland
State/province [99] 0 0
Zabrze
Country [100] 0 0
Russian Federation
State/province [100] 0 0
Moscow Region
Country [101] 0 0
Russian Federation
State/province [101] 0 0
Moscow
Country [102] 0 0
Russian Federation
State/province [102] 0 0
Saint Petersburg
Country [103] 0 0
Russian Federation
State/province [103] 0 0
Tomsk
Country [104] 0 0
Russian Federation
State/province [104] 0 0
Tumen
Country [105] 0 0
Spain
State/province [105] 0 0
Andalucia
Country [106] 0 0
Spain
State/province [106] 0 0
Asturias
Country [107] 0 0
Spain
State/province [107] 0 0
Cataluna
Country [108] 0 0
Spain
State/province [108] 0 0
Comunidad de Madrid
Country [109] 0 0
Spain
State/province [109] 0 0
Comunidad Valenciana

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The Cleveland Clinic
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Stephen J Nicholls, MBBS, PhD
Address 0 0
Cleveland Clinic Foundation, Cardiovascular Medicine
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.