CRESTOR Athero Imaging Head to Head IVUS Study

Condition(s) targeted: Coronary Atherosclerosis

Intervention: Rosuvastatin (Drug); Atorvastatin (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Stephen J Nicholls, MBBS, PhD, Principal Investigator, Affiliation: Cleveland Clinic Foundation, Cardiovascular Medicine

Overall contact:
AstraZeneca Clinical Study Information, Phone: 800-236-9933, Email: information.center@astrazeneca.com

A 104-week, randomized, double-blink, parallel group, multi-center Phase IIIb study comparing the effects of treatment with rosuvastatin 40 mg or atorvastatin 80mg on atherosclerotic disease burden as measured by intravascular ultrasound in patients with coronary artery disease.

Official title: Study of Coronary Atheroma by Intravascular Ultrasound: Effect of Rosuvastatin Versus Atorvastatin (SATURN)

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study

Primary outcome: To compare the effects of rosuvastatin with atorvastatin on the percent atheroma volume (PAV), as measured by IVUS

Secondary outcome: Regression of percent atheroma volume (PAV) , as measured by IVUS

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Clinical indication for coronary angiography

- Angiographic evidence of 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 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

AstraZeneca Clinical Study Information, Phone: 800-236-9933, Email: information.center@astrazeneca.com

Research Site, BUENOS AIRES, Argentina; Recruiting

Research Site, CIUDAD DE BUENOS AIRES, Argentina; Recruiting

Research Site, CORDOBA, Argentina; Recruiting

Research Site, CORRIENTES, Argentina; Not yet recruiting

Research Site, AALST, Belgium; Not yet recruiting

Research Site, BRUGGE, Belgium; Recruiting

Research Site, BRUSSELS (ANDERLECHT), Belgium; Not yet recruiting

Research Site, BRUSSELS (WOLUWE-ST-LAMBERT), Belgium; Recruiting

Research Site, CHARLEROI, Belgium; Recruiting

Research Site, EDEGEM, Belgium; Not yet recruiting

Research Site, GENK, Belgium; Recruiting

Research Site, SAO PAULO, Brazil; Recruiting

Research Site, MONTREAL, Canada; Recruiting

Research Site, QUEBEC, Canada; Recruiting

Research Site, BESANCON, France; Recruiting

Research Site, BRON, France; Recruiting

Research Site, CRETEIL, France; Recruiting

Research Site, LE PLESSIS-ROBINSON, France; Recruiting

Research Site, MARSEILLE CEDEX 5, France; Not yet recruiting

Research Site, PESSAC CEDEX, France; Recruiting

Research Site, QUINCY SOUS SENART, France; Not yet recruiting

Research Site, STRASBOURG, France; Not yet recruiting

Research Site, TOULOUSE CEDEX, France; Recruiting

Research Site, BUDAPEST, Hungary; Not yet recruiting

Research Site, SZGED, Hungary; Not yet recruiting

Research Site, ROMA, Italy; Recruiting

Research Site, D.F, Mexico; Recruiting

Research Site, MONTERREY, Mexico; Not yet recruiting

Research Site, TIJUANA, Mexico; Recruiting

Research Site, AGUASCALIENTES, Mexico; Recruiting

Research Site, PUEBLA, Mexico; Recruiting

Research Site, ALKMAAR, Netherlands; Not yet recruiting

Research Site, AMSTERDAM, Netherlands; Recruiting

Research Site, BREDA, Netherlands; Recruiting

Research Site, EINDHOVEN, Netherlands; Not yet recruiting

Research Site, ENSCHEDE, Netherlands; Recruiting

Research Site, LEEUWARDEN, Netherlands; Recruiting

Research Site, NIEUWEGEIN, Netherlands; Not yet recruiting

Research Site, NIJMEGEN, Netherlands; Not yet recruiting

Research Site, ROTTERDAM, Netherlands; Not yet recruiting

Research Site, ZWOLLE, Netherlands; Recruiting

Research Site, LODZ, Poland; Recruiting

Research Site, 47-200 KEDZIERZYN KOZLE, Poland; Not yet recruiting

Research Site, BIALYSTOK, Poland; Recruiting

Research Site, GDANSK, Poland; Not yet recruiting

Research Site, KATOWICE, Poland; Recruiting

Research Site, KRAKOW, Poland; Recruiting

Research Site, POLANICA-ZDROJ, Poland; Not yet recruiting

Research Site, POZNAN, Poland; Recruiting

Research Site, WARSZAWA, Poland; Recruiting

Research Site, ZABRZE, Poland; Not yet recruiting

Research Site, MALAGA, ANDALUCIA, Spain; Recruiting

Research Site, AREZZO, AR, Italy; Not yet recruiting

Research Site, OVIEDO, ASTURIAS, Spain; Recruiting

Research Site, BIRMINGHAM, Alabama, United States; Not yet recruiting

Research Site, HUNTSVILLE, Alabama, United States; Not yet recruiting

Research Site, CALGARY, Alberta, Canada; Recruiting

Research Site, EDMONTON, Alberta, Canada; Recruiting

Research Site, PHOENIX, Arizona, United States; Not yet recruiting

Research Site, LITTLE ROCK, Arkansas, United States; Not yet recruiting

Research Site, VANCOUVER, British Columbia, Canada; Recruiting

Research Site, VICTORIA, British Columbia, Canada; Recruiting

Research Site, CIUDAD AUTONOMA DE BS. AS., Buenos Aires, Argentina; Not yet recruiting

Research Site, CAP. FED., Buenos Aires-Argentina, Argentina; Recruiting

Research Site, BARCELONA, CATALUNA, Spain; Recruiting

Research Site, HOSPITALET DE LLOBREGAT(BARCEL, CATALUNA, Spain; Recruiting

Research Site, LOS ANGELES, California, United States; Recruiting

Research Site, MOUNTAIN VIEW, California, United States; Not yet recruiting

Research Site, SACRAMENTO, California, United States; Recruiting

Research Site, SAN DIEGO, California, United States; Not yet recruiting

Research Site, SANTA ROSA, California, United States; Not yet recruiting

Research Site, TORRANCE, California, United States; Recruiting

Research Site, AURORA, Colorado, United States; Not yet recruiting

Research Site, BOULDER, Colorado, United States; Recruiting

Research Site, GREELEY, Colorado, United States; Not yet recruiting

Research Site, MADRID, Comunidad De Madrid, Spain; Recruiting

Research Site, ALICANTE, Comunidad Valenciana, Spain; Recruiting

Research Site, FARMINGTON, Connecticut, United States; Recruiting

Research Site, WASHINGTON, District of Columbia, United States; Not yet recruiting

Research Site, CARIACICA, ES, Brazil; Recruiting

Research Site, VITORIA, ES, Brazil; Not yet recruiting

Research Site, FT LAUDERDALE, Florida, United States; Recruiting

Research Site, JACKSONVILLE, Florida, United States; Not yet recruiting

Research Site, MIAMI, Florida, United States; Not yet recruiting

Research Site, ORLANDO, Florida, United States; Recruiting

Research Site, SAFETY HARBOR, Florida, United States; Recruiting

Research Site, SARASOTA, Florida, United States; Recruiting

Research Site, TAMPA, Florida, United States; Recruiting

Research Site, WINTER HAVEN, Florida, United States; Not yet recruiting

Research Site, GOIANIA, GO, Brazil; Recruiting

Research Site, ATLANTA, Georgia, United States; Not yet recruiting

Research Site, AUGUSTA, Georgia, United States; Not yet recruiting

Research Site, AURORA, Illinois, United States; Not yet recruiting

Research Site, MAYWOOD, Illinois, United States; Not yet recruiting

Research Site, MERIONETTE PARK, Illinois, United States; Not yet recruiting

Research Site, SPRINGFIELD, Illinois, United States; Not yet recruiting

Research Site, ELKHART, Indiana, United States; Recruiting

Research Site, INDIANAPOLIS, Indiana, United States; Not yet recruiting

Research Site, MERRILLVILLE, Indiana, United States; Not yet recruiting

Research Site, VALPARAISO, Indiana, United States; Not yet recruiting

Research Site, DAVENPORT, Iowa, United States; Recruiting

Research Site, IOWA CITY, Iowa, United States; Not yet recruiting

Research Site, WEST DES MOINES, Iowa, United States; Not yet recruiting

Research Site, PALMA DE MALLORCA, Islas Baleares, Spain; Not yet recruiting

Research Site, GUADALAJARA, JALISCO, Mexico; Recruiting

Research Site, ASHLAND, Kentucky, United States; Not yet recruiting

Research Site, LEXINGTON, Kentucky, United States; Recruiting

Research Site, LOUISVILLE, Kentucky, United States; Recruiting

Research Site, COVINGTON, Louisiana, United States; Recruiting

Research Site, MILANO, MI, Italy; Recruiting

Research Site, ROZZANO, MI, Italy; Recruiting

Research Site, CUIABA, MT, Brazil; Not yet recruiting

Research Site, WINNIPEG, Manitoba, Canada; Recruiting

Research Site, COLUMBIA, Maryland, United States; Recruiting

Research Site, TAKOMA PARK, Maryland, United States; Not yet recruiting

Research Site, BAY CITY, Michigan, United States; Recruiting

Research Site, KALAMAZOO, Michigan, United States; Recruiting

Research Site, MIDLAND, Michigan, United States; Recruiting

Research Site, MUSKEGON, Michigan, United States; Not yet recruiting

Research Site, PETOSKEY, Michigan, United States; Recruiting

Research Site, SAGINAW, Michigan, United States; Recruiting

Research Site, SOUTHFIELD, Michigan, United States; Not yet recruiting

Research Site, DULUTH, Minnesota, United States; Recruiting

Research Site, MINNEAPOLIS, Minnesota, United States; Recruiting

Research Site, ROCHESTER, Minnesota, United States; Not yet recruiting

Research Site, ST CLOUD, Minnesota, United States; Recruiting

Research Site, ST. PAUL, Minnesota, United States; Recruiting

Research Site, COLUMBIA, Missouri, United States; Recruiting

Research Site, KANSAS CITY, Missouri, United States; Not yet recruiting

Research Site, SPRINGFIELD, Missouri, United States; Not yet recruiting

Research Site, MISSOULA, Montana, United States; Not yet recruiting

Research Site, NOVARA, NO, Italy; Recruiting

Research Site, LINCOLN, Nebraska, United States; Not yet recruiting

Research Site, SAINT JOHN, New Brunswick, Canada; Recruiting

Research Site, NEW BRUNSWICK, New Jersey, United States; Not yet recruiting

Research Site, RIDGEWOOD, New Jersey, United States; Recruiting

Research Site, ALBUQUERQUE, New Mexico, United States; Not yet recruiting

Research Site, LIVERPOOL, New South Wales, Australia; Not yet recruiting

Research Site, NEW LAMBTON HEIGHTS, New South Wales, Australia; Not yet recruiting

Research Site, BUFFALO, New York, United States; Recruiting

Research Site, JOHNSON CITY, New York, United States; Recruiting

Research Site, NEW YORK, New York, United States; Recruiting

Research Site, ROSLYN, New York, United States; Not yet recruiting

Research Site, WILLIAMSVILLE, New York, United States; Recruiting

Research Site, CHARLOTTE, North Carolina, United States; Recruiting

Research Site, GASTONIA, North Carolina, United States; Not yet recruiting

Research Site, GREENSBORO, North Carolina, United States; Recruiting

Research Site, RALEIGH, North Carolina, United States; Not yet recruiting

Research Site, WILMINGTON, North Carolina, United States; Not yet recruiting

Research Site, FARGO, North Dakota, United States; Recruiting

Research Site, HALIFAX, Nova Scotia, Canada; Recruiting

Research Site, CANTON, Ohio, United States; Not yet recruiting

Research Site, CINCINNATI, Ohio, United States; Recruiting

Research Site, CLEVELAND, Ohio, United States; Recruiting

Research Site, COLUMBUS, Ohio, United States; Recruiting

Research Site, ELYRIA, Ohio, United States; Not yet recruiting

Research Site, KETTERING, Ohio, United States; Not yet recruiting

Research Site, MIDDLEBURG HEIGHTS, Ohio, United States; Not yet recruiting

Research Site, PERRYSBURG, Ohio, United States; Recruiting

Research Site, OKLAHOMA CITY, Oklahoma, United States; Recruiting

Research Site, TULSA, Oklahoma, United States; Recruiting

Research Site, HAMILTON, Ontario, Canada; Recruiting

Research Site, LONDON, Ontario, Canada; Recruiting

Research Site, NEWMARKET, Ontario, Canada; Not yet recruiting

Research Site, OTTAWA, Ontario, Canada; Recruiting

Research Site, TORONTO, Ontario, Canada; Recruiting

Research Site, BEND, Oregon, United States; Not yet recruiting

Research Site, EUGENE, Oregon, United States; Recruiting

Research Site, HILLSBORO, Oregon, United States; Recruiting

Research Site, CURITIBA, PR, Brazil; Recruiting

Research Site, PARMA, PR, Italy; Not yet recruiting

Research Site, DANVILLE, Pennsylvania, United States; Recruiting

Research Site, DOYLESTOWN, Pennsylvania, United States; Recruiting

Research Site, HERSHEY, Pennsylvania, United States; Recruiting

Research Site, PHILADELPHIA, Pennsylvania, United States; Recruiting

Research Site, PITTSBURGH, Pennsylvania, United States; Not yet recruiting

Research Site, WORMLEYSBURG, Pennsylvania, United States; Recruiting

Research Site, SANTIAGO DE QUERETARO, QUERETARO, Mexico; Recruiting

Research Site, CHICOUTIMI, Quebec, Canada; Recruiting

Research Site, LAVAL, Quebec, Canada; Recruiting

Research Site, MONTREAL, Quebec, Canada; Recruiting

Research Site, CHERMSIDE, Queensland, Australia; Recruiting

Research Site, PORTO ALEGRE, RS, Brazil; Not yet recruiting

Research Site, ROSARIO, SANTA FE, Argentina; Recruiting

Research Site, SIENA, SI, Italy; Recruiting

Research Site, RIBEIRAO PRETO, SP, Brazil; Recruiting

Research Site, SASKATOON, Saskatchewan, Canada; Recruiting

Research Site, ADELAIDE, South Australia, Australia; Recruiting

Research Site, BEDFORD PARK, South Australia, Australia; Not yet recruiting

Research Site, CHARLESTON, South Carolina, United States; Not yet recruiting

Research Site, GREENVILLE, South Carolina, United States; Not yet recruiting

Research Site, CHATTANOOGA, Tennessee, United States; Not yet recruiting

Research Site, GERMANTOWN, Tennessee, United States; Not yet recruiting

Research Site, KNOXVILLE, Tennessee, United States; Recruiting

Research Site, MEMPHIS, Tennessee, United States; Not yet recruiting

Research Site, NASHVILLE, Tennessee, United States; Not yet recruiting

Research Site, OAK RIDGE, Tennessee, United States; Recruiting

Research Site, AMARILLO, Texas, United States; Not yet recruiting

Research Site, DALLAS, Texas, United States; Not yet recruiting

Research Site, SAN ANTONIO, Texas, United States; Not yet recruiting

Research Site, UDINE, UD, Italy; Recruiting

Research Site, MURRAY, Utah, United States; Not yet recruiting

Research Site, MIRANO, VE, Italy; Not yet recruiting

Research Site, CHARLOTTESVILLE, Virginia, United States; Recruiting

Research Site, BELLEVUE, Washington, United States; Not yet recruiting

Research Site, SPOKANE, Washington, United States; Not yet recruiting

Research Site, TACOMA, Washington, United States; Not yet recruiting

Research Site, CHARLESTON, West Virginia, United States; Not yet recruiting

Research Site, PERTH, Western Australia, Australia; Not yet recruiting

Research Site, UBERLANDIA, mg, Brazil; Recruiting

Starting date: January 2008
Ending date: March 2011
Last updated: December 1, 2008