CRESTOR Athero Imaging Head to Head IVUS Study (SATURN)

July 11, 2012 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2333

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Research Site
      • Cordoba, Argentina
        • Research Site
      • Corrientes, Argentina
        • Research Site
    • Buenos Aires
      • Cap. Fed., Buenos Aires, Argentina
        • Research Site
      • Ciudad de Buenos Aires, Buenos Aires, Argentina
        • Research Site
    • Santa Fe-argentina
      • Rosario, Santa Fe-argentina, Argentina
        • Research Site
  • Australia
    • New South Wales
      • Liverpool, New South Wales, Australia
        • Research Site
      • New Lambton Heights, New South Wales, Australia
        • Research Site
    • Queensland
      • Chermside, Queensland, Australia
        • Research Site
    • South Australia
      • Adelaide, South Australia, Australia
        • Research Site
    • Western Australia
      • Perth, Western Australia, Australia
        • Research Site
  • Belgium
      • Aalst, Belgium
        • Research Site
      • Brugge, Belgium
        • Research Site
      • Brussels, Belgium
        • Research Site
      • Charleroi, Belgium
        • Research Site
      • Genk, Belgium
        • Research Site
      • Leuven, Belgium
        • Research Site
  • Brazil
    • ES
      • Cariacica, ES, Brazil
        • Research Site
      • Vitoria, ES, Brazil
        • Research Site
    • GO
      • Goiania, GO, Brazil
        • Research Site
    • MG
      • Uberlandia, MG, Brazil
        • Research Site
    • MT
      • Cuiaba, MT, Brazil
        • Research Site
    • PR
      • Curitiba, PR, Brazil
        • Research Site
    • SP
      • Ribeirao Preto, SP, Brazil
        • Research Site
      • Sao Paulo, SP, Brazil
        • Research Site
  • Canada
      • Quebec, Canada
        • Research Site
    • Alberta
      • Calgary, Alberta, Canada
        • Research Site
      • Edmonton, Alberta, Canada
        • Research Site
    • British Columbia
      • Vancouver, British Columbia, Canada
        • Research Site
      • Victoria, British Columbia, Canada
        • Research Site
    • Manitoba
      • Winnipeg, Manitoba, Canada
        • Research Site
    • New Brunswick
      • Saint John, New Brunswick, Canada
        • Research Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
        • Research Site
    • Ontario
      • Hamilton, Ontario, Canada
        • Research Site
      • London, Ontario, Canada
        • Research Site
      • Newmarket, Ontario, Canada
        • Research Site
      • Ottawa, Ontario, Canada
        • Research Site
      • Toronto, Ontario, Canada
        • Research Site
    • Quebec
      • Chicoutimi, Quebec, Canada
        • Research Site
      • Laval, Quebec, Canada
        • Research Site
      • Montreal, Quebec, Canada
        • Research Site
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada
        • Research Site
  • France
      • Besancon, France
        • Research Site
      • Bron, France
        • Research Site
      • Creteil, France
        • Research Site
      • Le Plessis-robinson, France
        • Research Site
      • Marseille, France
        • Research Site
      • Pessac, France
        • Research Site
      • Quincy Sous Senart, France
        • Research Site
      • Strasbourg, France
        • Research Site
      • Toulouse, France
        • Research Site
  • Hungary
      • Budapest, Hungary
        • Research Site
      • Szged, Hungary
        • Research Site
  • Italy
      • Novara, Italy
        • Research Site
      • Roma, Italy
        • Research Site
    • AR
      • Arezzo, AR, Italy
        • Research Site
    • MI
      • Milano, MI, Italy
        • Research Site
      • Rozzano, MI, Italy
        • Research Site
    • Milano
      • Sesto San Giovanni, Milano, Italy
        • Research Site
    • PR
      • Parma, PR, Italy
        • Research Site
    • SI
      • Siena, SI, Italy
        • Research Site
    • UD
      • Udine, UD, Italy
        • Research Site
  • Mexico
      • Aguascalientes, Mexico
        • Research Site
      • D.F, Mexico
        • Research Site
      • Monterrey, Mexico
        • Research Site
      • Puebla, Mexico
        • Research Site
      • Queretaro, Mexico
        • Research Site
      • Tijuana, Mexico
        • Research Site
    • Jalisco
      • Guadalajara, Jalisco, Mexico
        • Research Site
  • Netherlands
      • Alkmaar, Netherlands
        • Research Site
      • Amsterdam, Netherlands
        • Research Site
      • Breda, Netherlands
        • Research Site
      • Eindhoven, Netherlands
        • Research Site
      • Enschede, Netherlands
        • Research Site
      • Leeuwarden, Netherlands
        • Research Site
      • Nieuwegein, Netherlands
        • Research Site
      • Nijmegen, Netherlands
        • Research Site
      • Rotterdam, Netherlands
        • Research Site
      • Zwolle, Netherlands
        • Research Site
  • Poland
      • Bialystok, Poland
        • Research Site
      • Katowice, Poland
        • Research Site
      • Kedzierzyn Kozle, Poland
        • Research Site
      • Krakow, Poland
        • Research Site
      • Lodz, Poland
        • Research Site
      • Poznan, Poland
        • Research Site
      • Warszawa, Poland
        • Research Site
      • Zabrze, Poland
        • Research Site
  • Russian Federation
      • Moscow, Russian Federation
        • Research Site
      • Saint Petersburg, Russian Federation
        • Research Site
      • Tomsk, Russian Federation
        • Research Site
      • Tumen, Russian Federation
        • Research Site
    • Moscow Region
      • Krasnogorsk, Moscow Region, Russian Federation
        • Research Site
  • Spain
    • Andalucia
      • Malaga, Andalucia, Spain
        • Research Site
    • Asturias
      • Oviedo, Asturias, Spain
        • Research Site
    • Cataluna
      • Badalona, Cataluna, Spain
        • Research Site
      • Barcelona, Cataluna, Spain
        • Research Site
    • Comunidad Valenciana
      • Alicante, Comunidad Valenciana, Spain
        • Research Site
    • Comunidad de Madrid
      • Madrid, Comunidad de Madrid, Spain
        • Research Site
  • United States
    • Alabama
      • Huntsville, Alabama, United States
        • Research Site
    • California
      • Los Angeles, California, United States
        • Research Site
      • Mountain View, California, United States
        • Research Site
      • Sacramento, California, United States
        • Research Site
      • San Diego, California, United States
        • Research Site
      • Santa Rosa, California, United States
        • Research Site
      • Torrance, California, United States
        • Research Site
    • Colorado
      • Boulder, Colorado, United States
        • Research Site
      • Greeley, Colorado, United States
        • Research Site
      • Loveland, Colorado, United States
        • Research Site
    • Connecticut
      • Farmington, Connecticut, United States
        • Research Site
    • District of Columbia
      • Washington, District of Columbia, United States
        • Research Site
    • Florida
      • Clearwater, Florida, United States
        • Research Site
      • Ft Lauderdale, Florida, United States
        • Research Site
      • Jacksonville, Florida, United States
        • Research Site
      • Melbourne, Florida, United States
        • Research Site
      • Miami, Florida, United States
        • Research Site
      • Orlando, Florida, United States
        • Research Site
      • Sarasota, Florida, United States
        • Research Site
      • Tampa, Florida, United States
        • Research Site
      • Winter Haven, Florida, United States
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States
        • Research Site
      • Augusta, Georgia, United States
        • Research Site
    • Indiana
      • Elkhart, Indiana, United States
        • Research Site
      • Hammond, Indiana, United States
        • Research Site
      • Indianapolis, Indiana, United States
        • Research Site
      • Merrillville, Indiana, United States
        • Research Site
      • Valparaiso, Indiana, United States
        • Research Site
    • Iowa
      • Davenport, Iowa, United States
        • Research Site
      • Iowa City, Iowa, United States
        • Research Site
      • West Des Moines, Iowa, United States
        • Research Site
    • Kentucky
      • Ashland, Kentucky, United States
        • Research Site
      • Lexington, Kentucky, United States
        • Research Site
      • Louisville, Kentucky, United States
        • Research Site
    • Louisiana
      • Covington, Louisiana, United States
        • Research Site
    • Maryland
      • Bethesda, Maryland, United States
        • Research Site
      • Columbia, Maryland, United States
        • Research Site
      • Takoma Park, Maryland, United States
        • Research Site
    • Michigan
      • Bay City, Michigan, United States
        • Research Site
      • Grand Blanc, Michigan, United States
        • Research Site
      • Kalamazoo, Michigan, United States
        • Research Site
      • Midland, Michigan, United States
        • Research Site
      • Muskegon, Michigan, United States
        • Research Site
      • Petoskey, Michigan, United States
        • Research Site
      • Saginaw, Michigan, United States
        • Research Site
      • Southfield, Michigan, United States
        • Research Site
    • Minnesota
      • Duluth, Minnesota, United States
        • Research Site
      • Minneapolis, Minnesota, United States
        • Research Site
      • Rochester, Minnesota, United States
        • Research Site
      • St Cloud, Minnesota, United States
        • Research Site
      • St. Paul, Minnesota, United States
        • Research Site
    • Missouri
      • Columbia, Missouri, United States
        • Research Site
      • Kansas City, Missouri, United States
        • Research Site
    • Montana
      • Missoula, Montana, United States
        • Research Site
    • Nebraska
      • Lincoln, Nebraska, United States
        • Research Site
      • Omaha, Nebraska, United States
        • Research Site
    • New Jersey
      • New Brunswick, New Jersey, United States
        • Research Site
      • Ridgewood, New Jersey, United States
        • Research Site
    • New Mexico
      • Albuquerque, New Mexico, United States
        • Research Site
    • New York
      • Buffalo, New York, United States
        • Research Site
      • Johnson City, New York, United States
        • Research Site
      • New York, New York, United States
        • Research Site
      • Roslyn, New York, United States
        • Research Site
      • Williamsville, New York, United States
        • Research Site
    • North Carolina
      • Charlotte, North Carolina, United States
        • Research Site
      • Gastonia, North Carolina, United States
        • Research Site
      • Greensboro, North Carolina, United States
        • Research Site
    • North Dakota
      • Fargo, North Dakota, United States
        • Research Site
    • Ohio
      • Cincinnati, Ohio, United States
        • Research Site
      • Cleveland, Ohio, United States
        • Research Site
      • Columbus, Ohio, United States
        • Research Site
      • Elyria, Ohio, United States
        • Research Site
      • Kettering, Ohio, United States
        • Research Site
      • Middleburg Heights, Ohio, United States
        • Research Site
      • Perrysburg, Ohio, United States
        • Research Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • Research Site
      • Tulsa, Oklahoma, United States
        • Research Site
    • Oregon
      • Bend, Oregon, United States
        • Research Site
      • Eugene, Oregon, United States
        • Research Site
      • Hillsboro, Oregon, United States
        • Research Site
    • Pennsylvania
      • Danville, Pennsylvania, United States
        • Research Site
      • Doylestown, Pennsylvania, United States
        • Research Site
      • Hershey, Pennsylvania, United States
        • Research Site
      • Philadelphia, Pennsylvania, United States
        • Research Site
      • Wormleysburg, Pennsylvania, United States
        • Research Site
    • South Carolina
      • Charleston, South Carolina, United States
        • Research Site
    • Tennessee
      • Chattanooga, Tennessee, United States
        • Research Site
      • Germantown, Tennessee, United States
        • Research Site
      • Knoxville, Tennessee, United States
        • Research Site
      • Memphis, Tennessee, United States
        • Research Site
      • Oak Ridge, Tennessee, United States
        • Research Site
    • Texas
      • Dallas, Texas, United States
        • Research Site
      • San Antonio, Texas, United States
        • Research Site
    • Virginia
      • Charlottesville, Virginia, United States
        • Research Site
    • Washington
      • Bellevue, Washington, United States
        • Research Site
      • Spokane, Washington, United States
        • Research Site
      • Tacoma, Washington, United States
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rosuvastatin 20 mg
Rosuvastatin 20 mg distributed in 2-week run-in period
Drug: Rosuvastatin
capsule, oral, once daily
Other Names:
  • Crestor
Active Comparator: Atorvastatin 40 mg
Atorvastatin 40 mg distributed in 2-week run-in period
Drug: Atorvastatin
capsule, oral, one daily
Other Names:
  • Lipitor
Experimental: Rosuvastatin 40 mg
Rosuvastatin 40 mg distributed in core 2-year study
Drug: Rosuvastatin
capsule, oral, once daily
Other Names:
  • Crestor
Active Comparator: Atorvastatin 80 mg
Atorvastatin 80 mg distributed in core 2-year study
Drug: Atorvastatin
capsule, oral, one daily
Other Names:
  • Lipitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline to End of Study (Week 104) in Percent Atheroma Volume (PAV)
Time Frame: End of study (Week 104)

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numbers of Patients Showing Regression in PAV
Time Frame: End of study (Week 104)
Regression defined as a change from baseline in PAV < 0
End of study (Week 104)
Change From Baseline to End of Study (Week 104) in Total Atheroma Volume (TAV)
Time Frame: End of study (Week 104)
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.
End of study (Week 104)
Numbers of Patients Showing Regression in TAV
Time Frame: End of study (Week 104)
Regression defined as a change from baseline in TAV < 0
End of study (Week 104)
Total Cholesterol Blood Level
Time Frame: 104 weeks
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.
104 weeks
LDL-C Blood Level
Time Frame: 104 weeks
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.
104 weeks
HDL-C Blood Level
Time Frame: 104 weeks
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.
104 weeks
Triglycerides Blood Level
Time Frame: 104 weeks
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.
104 weeks
Non-HDL-C Blood Level
Time Frame: 104 weeks
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.
104 weeks
LDL-C/HDL-C Blood Level
Time Frame: 104 weeks
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.
104 weeks
Total Cholesterol/HDL-C Blood Level
Time Frame: 104 weeks
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.
104 weeks
Non-HDL-C/HDL-C Blood Level
Time Frame: 104 weeks
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.
104 weeks
Apolipoprotein B Blood Level
Time Frame: 104 weeks
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.
104 weeks
Apolipoprotein A-1 Blood Level
Time Frame: 104 weeks
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.
104 weeks
Apoliprotein B/Apolipoprotein A-1 Blood Level
Time Frame: 104 weeks
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.
104 weeks
VLDL-C During the 104 Week Treatment Period
Time Frame: 104 weeks
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.
104 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Collaborators

The Cleveland Clinic

Investigators

  • Principal Investigator: Stephen J Nicholls, MBBS, PhD, Cleveland Clinic Foundation, Cardiovascular Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

February 6, 2008

First Submitted That Met QC Criteria

February 20, 2008

First Posted (Estimate)

February 21, 2008

Study Record Updates

Last Update Posted (Estimate)

July 16, 2012

Last Update Submitted That Met QC Criteria

July 11, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D356IC00001
  • 2007-004000-13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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