Clinical trial NCT00620542: CRESTOR Athero Imaging Head to Head IVUS Study
Official title: Study of Coronary Atheroma by Intravascular Ultrasound: Effect of Rosuvastatin Versus Atorvastatin (SATURN)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Coronary Atherosclerosis
Keywords: Coronary artery disease
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: The Cleveland Clinic
First posted: 2008-02-21
Enrollment: 2333
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change From Baseline to End of Study (Week 104) in Percent Atheroma Volume (PAV)
timeFrame: End of study (Week 104)
Secondary outcomes:
measure: Numbers of Patients Showing Regression in PAV
timeFrame: End of study (Week 104)
measure: Change From Baseline to End of Study (Week 104) in Total Atheroma Volume (TAV)
timeFrame: End of study (Week 104)
measure: Numbers of Patients Showing Regression in TAV
timeFrame: End of study (Week 104)
measure: Total Cholesterol Blood Level
timeFrame: 104 weeks
measure: LDL-C Blood Level
timeFrame: 104 weeks
measure: HDL-C Blood Level
timeFrame: 104 weeks
measure: Triglycerides Blood Level
timeFrame: 104 weeks
measure: Non-HDL-C Blood Level
timeFrame: 104 weeks
measure: LDL-C/HDL-C Blood Level
timeFrame: 104 weeks
measure: Total Cholesterol/HDL-C Blood Level
timeFrame: 104 weeks
measure: Non-HDL-C/HDL-C Blood Level
timeFrame: 104 weeks
measure: Apolipoprotein B Blood Level
timeFrame: 104 weeks
measure: Apolipoprotein A-1 Blood Level
timeFrame: 104 weeks
measure: Apoliprotein B/Apolipoprotein A-1 Blood Level
timeFrame: 104 weeks
measure: VLDL-C During the 104 Week Treatment Period
timeFrame: 104 weeks
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Research Site
state: Alabama
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Mountain View
country: United States
facility: Research Site
state: California
city: Sacramento
country: United States
facility: Research Site
state: California
city: San Diego
country: United States
facility: Research Site
state: California
city: Santa Rosa
country: United States
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state: California
city: Torrance
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state: California
city: Boulder
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facility: Research Site
state: Colorado
city: Greeley
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city: Loveland
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city: Farmington
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state: Connecticut
city: Washington
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state: District of Columbia
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city: Ft Lauderdale
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city: Jacksonville
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city: Melbourne
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city: Miami
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city: Orlando
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city: Sarasota
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city: Tampa
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city: Hammond
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city: Petoskey
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city: Minneapolis
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city: Rochester
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city: St Cloud
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state: Minnesota
city: St. Paul
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city: Kansas City
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city: Lincoln
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city: Omaha
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city: Johnson City
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city: New York
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city: Roslyn
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city: Williamsville
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city: Charlotte
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state: North Carolina
city: Gastonia
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city: Greensboro
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city: Fargo
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city: Cincinnati
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city: Cleveland
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city: Columbus
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city: Elyria
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city: Kettering
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city: Middleburg Heights
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city: Perrysburg
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city: Oklahoma City
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city: Tulsa
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city: Bend
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city: Eugene
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city: Doylestown
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city: Chermside
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state: Queensland
city: Adelaide
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state: South Australia
city: Perth
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city: Aalst
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country: Brazil
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state: ES
city: Vitoria
country: Brazil
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city: Uberlandia
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state: MG
city: Cuiaba
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city: Curitiba
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city: Ribeirao Preto
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state: SP
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country: Canada
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city: Edmonton
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state: Alberta
city: Vancouver
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state: British Columbia
city: Victoria
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city: Winnipeg
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state: Manitoba
city: Saint John
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state: New Brunswick
city: Halifax
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state: Nova Scotia
city: Hamilton
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state: Ontario
city: London
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state: Ontario
city: Newmarket
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state: Ontario
city: Ottawa
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state: Ontario
city: Toronto
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state: Ontario
city: Chicoutimi
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state: Quebec
city: Laval
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state: Quebec
city: Montreal
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state: Quebec
city: Saskatoon
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state: Saskatchewan
city: Quebec
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city: Besancon
country: France
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city: Bron
country: France
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city: Creteil
country: France
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city: Le Plessis-robinson
country: France
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city: Marseille
country: France
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city: Pessac
country: France
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city: Quincy Sous Senart
country: France
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city: Strasbourg
country: France
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city: Toulouse
country: France
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city: Budapest
country: Hungary
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city: Szged
country: Hungary
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city: Arezzo
country: Italy
facility: Research Site
state: AR
city: Sesto San Giovanni
country: Italy
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state: Milano
city: Milano
country: Italy
facility: Research Site
state: MI
city: Rozzano
country: Italy
facility: Research Site
state: MI
city: Parma
country: Italy
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state: PR
city: Siena
country: Italy
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state: SI
city: Udine
country: Italy
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state: UD
city: Novara
country: Italy
facility: Research Site
city: Roma
country: Italy
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city: Guadalajara
country: Mexico
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state: Jalisco
city: Aguascalientes
country: Mexico
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city: D.F
country: Mexico
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city: Monterrey
country: Mexico
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city: Puebla
country: Mexico
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city: Queretaro
country: Mexico
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city: Tijuana
country: Mexico
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city: Alkmaar
country: Netherlands
facility: Research Site
city: Amsterdam
country: Netherlands
facility: Research Site
city: Breda
country: Netherlands
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city: Eindhoven
country: Netherlands
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city: Enschede
country: Netherlands
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city: Leeuwarden
country: Netherlands
facility: Research Site
city: Nieuwegein
country: Netherlands
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city: Nijmegen
country: Netherlands
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city: Rotterdam
country: Netherlands
facility: Research Site
city: Zwolle
country: Netherlands
facility: Research Site
city: Bialystok
country: Poland
facility: Research Site
city: Katowice
country: Poland
facility: Research Site
city: Kedzierzyn Kozle
country: Poland
facility: Research Site
city: Krakow
country: Poland
facility: Research Site
city: Lodz
country: Poland
facility: Research Site
city: Poznan
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Zabrze
country: Poland
facility: Research Site
city: Krasnogorsk
country: Russian Federation
facility: Research Site
state: Moscow Region
city: Moscow
country: Russian Federation
facility: Research Site
city: Saint Petersburg
country: Russian Federation
facility: Research Site
city: Tomsk
country: Russian Federation
facility: Research Site
city: Tumen
country: Russian Federation
facility: Research Site
city: Malaga
country: Spain
facility: Research Site
state: Andalucia
city: Oviedo
country: Spain
facility: Research Site
state: Asturias
city: Badalona
country: Spain
facility: Research Site
state: Cataluna
city: Barcelona
country: Spain
facility: Research Site
state: Cataluna
city: Madrid
country: Spain
facility: Research Site
state: Comunidad de Madrid
city: Alicante
country: Spain
facility: Research Site
state: Comunidad Valenciana
Study officials:
affiliation: Cleveland Clinic Foundation, Cardiovascular Medicine
name: Stephen J Nicholls, MBBS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.