CRESTOR Athero Imaging Head to Head IVUS Study
SATURN
Study of Coronary Atheroma by Intravascular Ultrasound: Effect of Rosuvastatin Versus Atorvastatin (SATURN)
2 other identifiers
interventional
2,333
14 countries
195
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2008
Typical duration for phase_3
195 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 6, 2008
CompletedFirst Posted
Study publicly available on registry
February 21, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedResults Posted
Study results publicly available
June 25, 2012
CompletedJuly 16, 2012
July 1, 2012
3.4 years
February 6, 2008
May 22, 2012
July 11, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
End of study (Week 104)
Secondary Outcomes (15)
Numbers of Patients Showing Regression in PAV
End of study (Week 104)
Change From Baseline to End of Study (Week 104) in Total Atheroma Volume (TAV)
End of study (Week 104)
Numbers of Patients Showing Regression in TAV
End of study (Week 104)
Total Cholesterol Blood Level
104 weeks
LDL-C Blood Level
104 weeks
- +10 more secondary outcomes
Study Arms (4)
Rosuvastatin 20 mg
EXPERIMENTALRosuvastatin 20 mg distributed in 2-week run-in period
Atorvastatin 40 mg
ACTIVE COMPARATORAtorvastatin 40 mg distributed in 2-week run-in period
Rosuvastatin 40 mg
EXPERIMENTALRosuvastatin 40 mg distributed in core 2-year study
Atorvastatin 80 mg
ACTIVE COMPARATORAtorvastatin 80 mg distributed in core 2-year study
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- The Cleveland Cliniccollaborator
Study Sites (195)
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Huntsville, Alabama, United States
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Los Angeles, California, United States
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Mountain View, California, United States
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Sacramento, California, United States
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San Diego, California, United States
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Santa Rosa, California, United States
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Torrance, California, United States
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Boulder, Colorado, United States
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Greeley, Colorado, United States
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Loveland, Colorado, United States
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Farmington, Connecticut, United States
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Washington D.C., District of Columbia, United States
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Clearwater, Florida, United States
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Fort Lauderdale, Florida, United States
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Jacksonville, Florida, United States
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Melbourne, Florida, United States
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Miami, Florida, United States
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Orlando, Florida, United States
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Sarasota, Florida, United States
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Tampa, Florida, United States
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Winter Haven, Florida, United States
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Atlanta, Georgia, United States
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Augusta, Georgia, United States
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Elkhart, Indiana, United States
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Hammond, Indiana, United States
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Indianapolis, Indiana, United States
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Merrillville, Indiana, United States
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Valparaiso, Indiana, United States
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Davenport, Iowa, United States
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Iowa City, Iowa, United States
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West Des Moines, Iowa, United States
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Ashland, Kentucky, United States
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Lexington, Kentucky, United States
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Louisville, Kentucky, United States
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Covington, Louisiana, United States
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Bethesda, Maryland, United States
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Columbia, Maryland, United States
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Takoma Park, Maryland, United States
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Bay City, Michigan, United States
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Grand Blanc, Michigan, United States
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Kalamazoo, Michigan, United States
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Midland, Michigan, United States
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Muskegon, Michigan, United States
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Petoskey, Michigan, United States
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Saginaw, Michigan, United States
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Southfield, Michigan, United States
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Duluth, Minnesota, United States
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Minneapolis, Minnesota, United States
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Rochester, Minnesota, United States
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Saint Cloud, Minnesota, United States
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Saint Paul, Minnesota, United States
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Columbia, Missouri, United States
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Kansas City, Missouri, United States
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Missoula, Montana, United States
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Lincoln, Nebraska, United States
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Omaha, Nebraska, United States
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New Brunswick, New Jersey, United States
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Ridgewood, New Jersey, United States
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Albuquerque, New Mexico, United States
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Buffalo, New York, United States
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Johnson City, New York, United States
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New York, New York, United States
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Roslyn, New York, United States
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Williamsville, New York, United States
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Charlotte, North Carolina, United States
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Gastonia, North Carolina, United States
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Greensboro, North Carolina, United States
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Fargo, North Dakota, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Columbus, Ohio, United States
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Elyria, Ohio, United States
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Kettering, Ohio, United States
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Middleburg Heights, Ohio, United States
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Perrysburg, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Tulsa, Oklahoma, United States
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Bend, Oregon, United States
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Eugene, Oregon, United States
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Hillsboro, Oregon, United States
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Danville, Pennsylvania, United States
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Doylestown, Pennsylvania, United States
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Hershey, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Wormleysburg, Pennsylvania, United States
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Charleston, South Carolina, United States
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Chattanooga, Tennessee, United States
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Germantown, Tennessee, United States
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Knoxville, Tennessee, United States
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Memphis, Tennessee, United States
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Oak Ridge, Tennessee, United States
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Dallas, Texas, United States
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San Antonio, Texas, United States
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Charlottesville, Virginia, United States
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Bellevue, Washington, United States
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Spokane, Washington, United States
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Tacoma, Washington, United States
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Buenos Aires, Buenos Aires, Argentina
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Cap. Fed., Buenos Aires, Argentina
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Ciudad de Buenos Aires, Buenos Aires, Argentina
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Corrientes, Corrientes Province, Argentina
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Córdoba, Córdoba Province, Argentina
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Rosario, Santa Fe-argentina, Argentina
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Liverpool, New South Wales, Australia
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New Lambton Heights, New South Wales, Australia
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Chermside, Queensland, Australia
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Adelaide, South Australia, Australia
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Perth, Western Australia, Australia
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Aalst, Belgium, Belgium
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Bruges, Belgium, Belgium
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Brussels, Belgium, Belgium
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Charleroi, Belgium, Belgium
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Genk, Belgium, Belgium
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Leuven, Belgium, Belgium
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Cariacica, Espírito Santo, Brazil
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Vitória, Espírito Santo, Brazil
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Goiânia, Goiás, Brazil
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Cuiabá, Mato Grosso, Brazil
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Uberlândia, Minas Gerais, Brazil
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Curitiba, Paraná, Brazil
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Ribeirão Preto, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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Vancouver, British Columbia, Canada
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Victoria, British Columbia, Canada
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Winnipeg, Manitoba, Canada
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Saint John, New Brunswick, Canada
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Halifax, Nova Scotia, Canada
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Hamilton, Ontario, Canada
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London, Ontario, Canada
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Newmarket, Ontario, Canada
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Ottawa, Ontario, Canada
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Toronto, Ontario, Canada
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Chicoutimi, Quebec, Canada
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Laval, Quebec, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Saskatoon, Saskatchewan, Canada
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Besançon, France
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Bron, France
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Créteil, France
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Le Plessis-Robinson, France
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Marseille, France
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Pessac, France
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Quincy-sous-Sénart, France
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Strasbourg, France
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Toulouse, France
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Budapest, Hungary
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Szged, Hungary
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Arezzo, AR, Italy
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Sesto San Giovanni, Milano, Italy
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Milan, MI, Italy
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Rozzano, MI, Italy
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Parma, PR, Italy
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Siena, SI, Italy
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Udine, UD, Italy
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Novara, Italy
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Roma, Italy
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Aguascalientes, Aguascalientes, Mexico
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Guadalajara, Jalisco, Mexico
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D.F, Mexico, Mexico
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Puebla City, Puebla, Mexico
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Querétaro City, Querétaro, Mexico
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Monterrey, Mexico
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Tijuana, Mexico
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Alkmaar, Netherlands
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Amsterdam, Netherlands
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Breda, Netherlands
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Eindhoven, Netherlands
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Enschede, Netherlands
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Leeuwarden, Netherlands
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Nieuwegein, Netherlands
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Nijmegen, Netherlands
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Rotterdam, Netherlands
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Zwolle, Netherlands
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Bialystok, Poland
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Katowice, Poland
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Kędzierzyn-Koźle, Poland
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Krakow, Poland
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Lodz, Poland
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Poznan, Poland
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Warsaw, Poland
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Zabrze, Poland
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Krasnogorsk, Moscow Oblast, Russia
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Moscow, Russia
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Saint Petersburg, Russia
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Tomsk, Russia
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Tyumen, Russia
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Málaga, Andalusia, Spain
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Badalona, Catalonia, Spain
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Barcelona, Catalonia, Spain
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Madrid, Madrid, Spain
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Oviedo, Principality of Asturias, Spain
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Alicante, Valencia, Spain
Related Publications (4)
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.
PMID: 25240453DERIVEDPuri 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.
PMID: 24448227DERIVEDPuri 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.
PMID: 24043299DERIVEDNicholls 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.
PMID: 22085316DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gerard Lynch
- Organization
- AstraZeneca
Study Officials
- PRINCIPAL INVESTIGATOR
Stephen J Nicholls, MBBS, PhD
Cleveland Clinic Foundation, Cardiovascular Medicine
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 6, 2008
First Posted
February 21, 2008
Study Start
January 1, 2008
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
July 16, 2012
Results First Posted
June 25, 2012
Record last verified: 2012-07