Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
2333 participants
INTERVENTIONAL
2008-01-31
2011-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Rosuvastatin 20 mg
Rosuvastatin 20 mg distributed in 2-week run-in period
Rosuvastatin
capsule, oral, once daily
Atorvastatin 40 mg
Atorvastatin 40 mg distributed in 2-week run-in period
Atorvastatin
capsule, oral, one daily
Rosuvastatin 40 mg
Rosuvastatin 40 mg distributed in core 2-year study
Rosuvastatin
capsule, oral, once daily
Atorvastatin 80 mg
Atorvastatin 80 mg distributed in core 2-year study
Atorvastatin
capsule, oral, one daily
Interventions
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Rosuvastatin
capsule, oral, once daily
Atorvastatin
capsule, oral, one daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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The Cleveland Clinic
OTHER
AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Stephen J Nicholls, MBBS, PhD
Role: PRINCIPAL_INVESTIGATOR
Cleveland Clinic Foundation, Cardiovascular Medicine
Locations
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Research Site
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
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Monterrey, , Mexico
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Tijuana, , Mexico
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Alkmaar, , Netherlands
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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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Amsterdam, , Netherlands
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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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Breda, , Netherlands
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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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Eindhoven, , Netherlands
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Enschede, , Netherlands
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Leeuwarden, , Netherlands
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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
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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2007-004000-13
Identifier Type: -
Identifier Source: secondary_id
D356IC00001
Identifier Type: -
Identifier Source: org_study_id