Back to resultsCRESTOR Athero Imaging Head to Head IVUS Study (SATURN)
Primary Purpose
Coronary Atherosclerosis
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Rosuvastatin
Atorvastatin
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Atherosclerosis focused on measuring Coronary artery disease
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
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Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Experimental
Active Comparator
Arm Label
Rosuvastatin 20 mg
Atorvastatin 40 mg
Rosuvastatin 40 mg
Atorvastatin 80 mg
Arm Description
Rosuvastatin 20 mg distributed in 2-week run-in period
Atorvastatin 40 mg distributed in 2-week run-in period
Rosuvastatin 40 mg distributed in core 2-year study
Atorvastatin 80 mg distributed in core 2-year study
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Numbers of Patients Showing Regression in PAV
Regression defined as a change from baseline in PAV < 0
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.
Numbers of Patients Showing Regression in TAV
Regression defined as a change from baseline in TAV < 0
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT00620542
First Posted
February 6, 2008
Last Updated
July 11, 2012
Sponsor
AstraZeneca
Collaborators
The Cleveland Clinic
1. Study Identification
Unique Protocol Identification Number
NCT00620542
Brief Title
CRESTOR Athero Imaging Head to Head IVUS Study
Acronym
SATURN
Official Title
Study of Coronary Atheroma by Intravascular Ultrasound: Effect of Rosuvastatin Versus Atorvastatin (SATURN)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
Collaborators
The Cleveland Clinic
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Atherosclerosis
Keywords
Coronary artery disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2333 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rosuvastatin 20 mg
Arm Type
Experimental
Arm Description
Rosuvastatin 20 mg distributed in 2-week run-in period
Arm Title
Atorvastatin 40 mg
Arm Type
Active Comparator
Arm Description
Atorvastatin 40 mg distributed in 2-week run-in period
Arm Title
Rosuvastatin 40 mg
Arm Type
Experimental
Arm Description
Rosuvastatin 40 mg distributed in core 2-year study
Arm Title
Atorvastatin 80 mg
Arm Type
Active Comparator
Arm Description
Atorvastatin 80 mg distributed in core 2-year study
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin
Other Intervention Name(s)
Crestor
Intervention Description
capsule, oral, once daily
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Other Intervention Name(s)
Lipitor
Intervention Description
capsule, oral, one daily
Primary Outcome Measure Information:
Title
Change From Baseline to End of Study (Week 104) in Percent Atheroma Volume (PAV)
Description
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.
Time Frame
End of study (Week 104)
Secondary Outcome Measure Information:
Title
Numbers of Patients Showing Regression in PAV
Description
Regression defined as a change from baseline in PAV < 0
Time Frame
End of study (Week 104)
Title
Change From Baseline to End of Study (Week 104) in Total Atheroma Volume (TAV)
Description
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.
Time Frame
End of study (Week 104)
Title
Numbers of Patients Showing Regression in TAV
Description
Regression defined as a change from baseline in TAV < 0
Time Frame
End of study (Week 104)
Title
Total Cholesterol Blood Level
Description
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.
Time Frame
104 weeks
Title
LDL-C Blood Level
Description
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.
Time Frame
104 weeks
Title
HDL-C Blood Level
Description
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.
Time Frame
104 weeks
Title
Triglycerides Blood Level
Description
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.
Time Frame
104 weeks
Title
Non-HDL-C Blood Level
Description
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.
Time Frame
104 weeks
Title
LDL-C/HDL-C Blood Level
Description
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.
Time Frame
104 weeks
Title
Total Cholesterol/HDL-C Blood Level
Description
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.
Time Frame
104 weeks
Title
Non-HDL-C/HDL-C Blood Level
Description
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.
Time Frame
104 weeks
Title
Apolipoprotein B Blood Level
Description
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.
Time Frame
104 weeks
Title
Apolipoprotein A-1 Blood Level
Description
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.
Time Frame
104 weeks
Title
Apoliprotein B/Apolipoprotein A-1 Blood Level
Description
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.
Time Frame
104 weeks
Title
VLDL-C During the 104 Week Treatment Period
Description
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.
Time Frame
104 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen J Nicholls, MBBS, PhD
Organizational Affiliation
Cleveland Clinic Foundation, Cardiovascular Medicine
Official's Role
Principal Investigator
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Huntsville
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Cap. Fed.
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Argentina
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Ciudad de Buenos Aires
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Argentina
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Rosario
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Argentina
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Buenos Aires
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Argentina
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Cordoba
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Argentina
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Corrientes
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Argentina
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Liverpool
State/Province
New South Wales
Country
Australia
Facility Name
Research Site
City
New Lambton Heights
State/Province
New South Wales
Country
Australia
Facility Name
Research Site
City
Chermside
State/Province
Queensland
Country
Australia
Facility Name
Research Site
City
Adelaide
State/Province
South Australia
Country
Australia
Facility Name
Research Site
City
Perth
State/Province
Western Australia
Country
Australia
Facility Name
Research Site
City
Aalst
Country
Belgium
Facility Name
Research Site
City
Brugge
Country
Belgium
Facility Name
Research Site
City
Brussels
Country
Belgium
Facility Name
Research Site
City
Charleroi
Country
Belgium
Facility Name
Research Site
City
Genk
Country
Belgium
Facility Name
Research Site
City
Leuven
Country
Belgium
Facility Name
Research Site
City
Cariacica
State/Province
ES
Country
Brazil
Facility Name
Research Site
City
Vitoria
State/Province
ES
Country
Brazil
Facility Name
Research Site
City
Goiania
State/Province
GO
Country
Brazil
Facility Name
Research Site
City
Uberlandia
State/Province
MG
Country
Brazil
Facility Name
Research Site
City
Cuiaba
State/Province
MT
Country
Brazil
Facility Name
Research Site
City
Curitiba
State/Province
PR
Country
Brazil
Facility Name
Research Site
City
Ribeirao Preto
State/Province
SP
Country
Brazil
Facility Name
Research Site
City
Sao Paulo
State/Province
SP
Country
Brazil
Facility Name
Research Site
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
Research Site
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
Research Site
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
Research Site
City
Victoria
State/Province
British Columbia
Country
Canada
Facility Name
Research Site
City
Winnipeg
State/Province
Manitoba
Country
Canada
Facility Name
Research Site
City
Saint John
State/Province
New Brunswick
Country
Canada
Facility Name
Research Site
City
Halifax
State/Province
Nova Scotia
Country
Canada
Facility Name
Research Site
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
London
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Newmarket
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Chicoutimi
State/Province
Quebec
Country
Canada
Facility Name
Research Site
City
Laval
State/Province
Quebec
Country
Canada
Facility Name
Research Site
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Research Site
City
Saskatoon
State/Province
Saskatchewan
Country
Canada
Facility Name
Research Site
City
Quebec
Country
Canada
Facility Name
Research Site
City
Besancon
Country
France
Facility Name
Research Site
City
Bron
Country
France
Facility Name
Research Site
City
Creteil
Country
France
Facility Name
Research Site
City
Le Plessis-robinson
Country
France
Facility Name
Research Site
City
Marseille
Country
France
Facility Name
Research Site
City
Pessac
Country
France
Facility Name
Research Site
City
Quincy Sous Senart
Country
France
Facility Name
Research Site
City
Strasbourg
Country
France
Facility Name
Research Site
City
Toulouse
Country
France
Facility Name
Research Site
City
Budapest
Country
Hungary
Facility Name
Research Site
City
Szged
Country
Hungary
Facility Name
Research Site
City
Arezzo
State/Province
AR
Country
Italy
Facility Name
Research Site
City
Sesto San Giovanni
State/Province
Milano
Country
Italy
Facility Name
Research Site
City
Milano
State/Province
MI
Country
Italy
Facility Name
Research Site
City
Rozzano
State/Province
MI
Country
Italy
Facility Name
Research Site
City
Parma
State/Province
PR
Country
Italy
Facility Name
Research Site
City
Siena
State/Province
SI
Country
Italy
Facility Name
Research Site
City
Udine
State/Province
UD
Country
Italy
Facility Name
Research Site
City
Novara
Country
Italy
Facility Name
Research Site
City
Roma
Country
Italy
Facility Name
Research Site
City
Guadalajara
State/Province
Jalisco
Country
Mexico
Facility Name
Research Site
City
Aguascalientes
Country
Mexico
Facility Name
Research Site
City
D.F
Country
Mexico
Facility Name
Research Site
City
Monterrey
Country
Mexico
Facility Name
Research Site
City
Puebla
Country
Mexico
Facility Name
Research Site
City
Queretaro
Country
Mexico
Facility Name
Research Site
City
Tijuana
Country
Mexico
Facility Name
Research Site
City
Alkmaar
Country
Netherlands
Facility Name
Research Site
City
Amsterdam
Country
Netherlands
Facility Name
Research Site
City
Breda
Country
Netherlands
Facility Name
Research Site
City
Eindhoven
Country
Netherlands
Facility Name
Research Site
City
Enschede
Country
Netherlands
Facility Name
Research Site
City
Leeuwarden
Country
Netherlands
Facility Name
Research Site
City
Nieuwegein
Country
Netherlands
Facility Name
Research Site
City
Nijmegen
Country
Netherlands
Facility Name
Research Site
City
Rotterdam
Country
Netherlands
Facility Name
Research Site
City
Zwolle
Country
Netherlands
Facility Name
Research Site
City
Bialystok
Country
Poland
Facility Name
Research Site
City
Katowice
Country
Poland
Facility Name
Research Site
City
Kedzierzyn Kozle
Country
Poland
Facility Name
Research Site
City
Krakow
Country
Poland
Facility Name
Research Site
City
Lodz
Country
Poland
Facility Name
Research Site
City
Poznan
Country
Poland
Facility Name
Research Site
City
Warszawa
Country
Poland
Facility Name
Research Site
City
Zabrze
Country
Poland
Facility Name
Research Site
City
Krasnogorsk
State/Province
Moscow Region
Country
Russian Federation
Facility Name
Research Site
City
Moscow
Country
Russian Federation
Facility Name
Research Site
City
Saint Petersburg
Country
Russian Federation
Facility Name
Research Site
City
Tomsk
Country
Russian Federation
Facility Name
Research Site
City
Tumen
Country
Russian Federation
Facility Name
Research Site
City
Malaga
State/Province
Andalucia
Country
Spain
Facility Name
Research Site
City
Oviedo
State/Province
Asturias
Country
Spain
Facility Name
Research Site
City
Badalona
State/Province
Cataluna
Country
Spain
Facility Name
Research Site
City
Barcelona
State/Province
Cataluna
Country
Spain
Facility Name
Research Site
City
Madrid
State/Province
Comunidad de Madrid
Country
Spain
Facility Name
Research Site
City
Alicante
State/Province
Comunidad Valenciana
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
25240453
Citation
Puri R, Nissen SE, Shao M, Ballantyne CM, Barter PJ, Chapman MJ, Erbel R, Libby P, Raichlen JS, Uno K, Kataoka Y, Nicholls SJ. Sex-related differences of coronary atherosclerosis regression following maximally intensive statin therapy: insights from SATURN. JACC Cardiovasc Imaging. 2014 Oct;7(10):1013-22. doi: 10.1016/j.jcmg.2014.04.019. Epub 2014 Sep 17.
Results Reference
derived
PubMed Identifier
24448227
Citation
Puri R, Libby P, Nissen SE, Wolski K, Ballantyne CM, Barter PJ, Chapman MJ, Erbel R, Raichlen JS, Uno K, Kataoka Y, Tuzcu EM, Nicholls SJ. Long-term effects of maximally intensive statin therapy on changes in coronary atheroma composition: insights from SATURN. Eur Heart J Cardiovasc Imaging. 2014 Apr;15(4):380-8. doi: 10.1093/ehjci/jet251. Epub 2014 Jan 20.
Results Reference
derived
PubMed Identifier
24043299
Citation
Puri R, Nissen SE, Libby P, Shao M, Ballantyne CM, Barter PJ, Chapman MJ, Erbel R, Raichlen JS, Uno K, Kataoka Y, Nicholls SJ. C-reactive protein, but not low-density lipoprotein cholesterol levels, associate with coronary atheroma regression and cardiovascular events after maximally intensive statin therapy. Circulation. 2013 Nov 26;128(22):2395-403. doi: 10.1161/CIRCULATIONAHA.113.004243. Epub 2013 Sep 16.
Results Reference
derived
PubMed Identifier
22085316
Citation
Nicholls SJ, Ballantyne CM, Barter PJ, Chapman MJ, Erbel RM, Libby P, Raichlen JS, Uno K, Borgman M, Wolski K, Nissen SE. Effect of two intensive statin regimens on progression of coronary disease. N Engl J Med. 2011 Dec 1;365(22):2078-87. doi: 10.1056/NEJMoa1110874. Epub 2011 Nov 15.
Results Reference
derived
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CRESTOR Athero Imaging Head to Head IVUS Study
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