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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
1/01/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2011
Sample size
Target
Accrual to date
Final
2333
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
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United States of America
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Georgia
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Indiana
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Iowa
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Kentucky
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Louisiana
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Maryland
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Michigan
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Minnesota
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Missouri
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Montana
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Nebraska
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New Jersey
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New Mexico
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New York
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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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Pennsylvania
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South Carolina
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Tennessee
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Texas
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Virginia
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United States of America
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Washington
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Argentina
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Buenos Aires
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Argentina
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Santa Fe-argentina
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Argentina
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Cordoba
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Argentina
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Corrientes
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Belgium
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Aalst
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Belgium
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Brugge
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Brussels
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Charleroi
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Genk
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Leuven
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ES
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GO
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MG
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Bron
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Creteil
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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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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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AR
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Italy
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Milano
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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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Novara
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Roma
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Jalisco
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D.F
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Monterrey
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Puebla
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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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Amsterdam
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Breda
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Eindhoven
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Enschede
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Leeuwarden
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Nieuwegein
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Nijmegen
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Rotterdam
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Zwolle
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Poland
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Bialystok
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Katowice
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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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Warszawa
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Zabrze
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Russian Federation
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Moscow Region
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Moscow
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Saint Petersburg
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Russian Federation
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Tomsk
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Russian Federation
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Tumen
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Spain
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Andalucia
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Spain
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Asturias
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Spain
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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.

Results are available at https://clinicaltrials.gov/study/NCT00620542