Coronary AtherosclerosisPhase 3SATURNNCT00620542

CRESTOR Athero Imaging Head to Head IVUS Study

A Phase 3 study testing Rosuvastatin and Atorvastatin in people with Coronary Atherosclerosis, run by AstraZeneca at 195 sites in 14 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Coronary Atherosclerosis
What is being tested?: Rosuvastatin and Atorvastatin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2,333 participants
Where: 195 sitesin 14 countries
Study dates: Jan 2008to Jun 2011
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

195 sites in 14 countries.

Country

City, postcode or hospital

195 sites in 14 countries

United States97 sites

Research Site
Albuquerque, New Mexico
Research Site
Ashland, Kentucky
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Atlanta, Georgia
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Augusta, Georgia
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Bay City, Michigan
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Bellevue, Washington
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Bend, Oregon
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Bethesda, Maryland
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Boulder, Colorado
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Buffalo, New York
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Charleston, South Carolina
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Charlotte, North Carolina
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Charlottesville, Virginia
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Chattanooga, Tennessee
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Cincinnati, Ohio
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Clearwater, Florida
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Cleveland, Ohio
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Columbia, Maryland
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Columbia, Missouri
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Columbus, Ohio
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Covington, Louisiana
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Dallas, Texas
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Danville, Pennsylvania
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Davenport, Iowa
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Doylestown, Pennsylvania
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Duluth, Minnesota
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Elkhart, Indiana
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Elyria, Ohio
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Eugene, Oregon
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Fargo, North Dakota
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Farmington, Connecticut
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Fort Lauderdale, Florida
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Gastonia, North Carolina
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Germantown, Tennessee
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Grand Blanc, Michigan
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Greeley, Colorado
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Greensboro, North Carolina
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Hammond, Indiana
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Hershey, Pennsylvania
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Hillsboro, Oregon
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Huntsville, Alabama
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Indianapolis, Indiana
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Iowa City, Iowa
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Jacksonville, Florida
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Johnson City, New York
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Kalamazoo, Michigan
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Kansas City, Missouri
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Kettering, Ohio
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Knoxville, Tennessee
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Lexington, Kentucky
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Lincoln, Nebraska
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Los Angeles, California
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Louisville, Kentucky
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Loveland, Colorado
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Melbourne, Florida
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Memphis, Tennessee
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Merrillville, Indiana
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Miami, Florida
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Middleburg Heights, Ohio
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Midland, Michigan
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Minneapolis, Minnesota
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Missoula, Montana
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Mountain View, California
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Muskegon, Michigan
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New Brunswick, New Jersey
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New York, New York
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Oak Ridge, Tennessee
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Oklahoma City, Oklahoma
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Omaha, Nebraska
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Orlando, Florida
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Perrysburg, Ohio
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Petoskey, Michigan
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Philadelphia, Pennsylvania
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Ridgewood, New Jersey
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Rochester, Minnesota
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Roslyn, New York
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Sacramento, California
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Saginaw, Michigan
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Saint Cloud, Minnesota
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Saint Paul, Minnesota
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San Antonio, Texas
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San Diego, California
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Santa Rosa, California
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Sarasota, Florida
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Southfield, Michigan
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Spokane, Washington
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Tacoma, Washington
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Takoma Park, Maryland
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Tampa, Florida
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Torrance, California
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Tulsa, Oklahoma
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Valparaiso, Indiana
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Washington D.C., District of Columbia
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West Des Moines, Iowa
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Williamsville, New York
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Winter Haven, Florida
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Wormleysburg, Pennsylvania

Other trials in United States

Canada17 sites

Research Site
Calgary, Alberta
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Chicoutimi, Quebec
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Edmonton, Alberta
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Halifax, Nova Scotia
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Hamilton, Ontario
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Laval, Quebec
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London, Ontario
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Montreal, Quebec
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Newmarket, Ontario
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Ottawa, Ontario
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Québec, Quebec
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Saint John, New Brunswick
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Saskatoon, Saskatchewan
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Toronto, Ontario
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Vancouver, British Columbia
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Victoria, British Columbia
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Winnipeg, Manitoba

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Netherlands10 sites

Research Site
Alkmaar
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Amsterdam
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Breda
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Eindhoven
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Enschede
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Leeuwarden
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Nieuwegein
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Nijmegen
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Rotterdam
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Zwolle

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France9 sites

Research Site
Besançon
Research Site
Bron
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Créteil
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Le Plessis-Robinson
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Marseille
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Pessac
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Quincy-sous-Sénart
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Strasbourg
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Toulouse

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Italy9 sites

Research Site
Arezzo, AR
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Milan, MI
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Novara
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Parma, PR
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Roma
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Rozzano, MI
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Sesto San Giovanni, Milano
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Siena, SI
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Udine, UD

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Brazil8 sites

Research Site
Cariacica, Espírito Santo
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Cuiabá, Mato Grosso
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Curitiba, Paraná
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Goiânia, Goiás
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Ribeirão Preto, São Paulo
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São Paulo, São Paulo
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Uberlândia, Minas Gerais
Research Site
Vitória, Espírito Santo

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Poland8 sites

Research Site
Bialystok
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Katowice
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Kędzierzyn-Koźle
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Krakow
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Lodz
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Poznan
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Warsaw
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Zabrze

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Mexico7 sites

Research Site
Aguascalientes, Aguascalientes
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D.F, Mexico
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Guadalajara, Jalisco
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Monterrey
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Puebla City, Puebla
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Querétaro City, Querétaro
Research Site
Tijuana

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Argentina6 sites

Research Site
Buenos Aires, Buenos Aires
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Cap. Fed., Buenos Aires
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Ciudad de Buenos Aires, Buenos Aires
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Córdoba, Córdoba Province
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Corrientes, Corrientes Province
Research Site
Rosario, Santa Fe-argentina

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Belgium6 sites

Research Site
Aalst, Belgium
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Bruges, Belgium
Research Site
Brussels, Belgium
Research Site
Charleroi, Belgium
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Genk, Belgium
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Leuven, Belgium

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Spain6 sites

Research Site
Alicante, Valencia
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Badalona, Catalonia
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Barcelona, Catalonia
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Madrid, Madrid
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Málaga, Andalusia
Research Site
Oviedo, Principality of Asturias

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Australia5 sites

Research Site
Adelaide, South Australia
Research Site
Chermside, Queensland
Research Site
Liverpool, New South Wales
Research Site
New Lambton Heights, New South Wales
Research Site
Perth, Western Australia

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Russia5 sites

Research Site
Krasnogorsk, Moscow Oblast
Research Site
Moscow
Research Site
Saint Petersburg
Research Site
Tomsk
Research Site
Tyumen

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Hungary2 sites

Research Site
Budapest
Research Site
Szged

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About this study

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

Conditions: Coronary Atherosclerosis
Being tested: Rosuvastatin, Atorvastatin
Keywords: Coronary artery disease
Medical subject headings: Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RosuvastatinDrug
Also called Crestor
capsule, oral, once daily
AtorvastatinDrug
Also called Lipitor
capsule, oral, one daily

Study groups in NCT00620542
Study group	Role	What they receive
Rosuvastatin 20 mg	Experimental	Rosuvastatin 20 mg distributed in 2-week run-in period Receives: Drug: Rosuvastatin
Atorvastatin 40 mg	Active comparator	Atorvastatin 40 mg distributed in 2-week run-in period Receives: Drug: Atorvastatin
Rosuvastatin 40 mg	Experimental	Rosuvastatin 40 mg distributed in core 2-year study Receives: Drug: Rosuvastatin
Atorvastatin 80 mg	Active comparator	Atorvastatin 80 mg distributed in core 2-year study Receives: Drug: Atorvastatin

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: End of study (Week 104)

Secondary outcomes (15)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2008Jun 2011

First posted21 Feb 2008 (estimated)
Study startJan 2008
Primary completionJun 2011
Study completionJun 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Coronary AtherosclerosisStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 2,333 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00620542
Sponsor's protocol ID: D356IC00001
Other IDs: 2007-004000-13
Acronym: SATURN
Status last verified: Jul 2012
First submitted: 6 Feb 2008
Last updated: 16 Jul 2012
Results posted: Yes, on ClinicalTrials.gov

Publications

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.
PubMed 25240453
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.
PubMed 24448227
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.
PubMed 24043299
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.
PubMed 22085316

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 16 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study of Coronary Atheroma by Intravascular Ultrasound: Effect of Rosuvastatin Versus Atorvastatin (SATURN)
ClinicalTrials.gov ID: NCT00620542
Acronym / sponsor ID: SATURN / D356IC00001
Conditions: Coronary Atherosclerosis
Keywords: Coronary artery disease
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 2,333 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Collaborators: The Cleveland Clinic
Study start: Jan 2008
Primary completion: Jun 2011 (actual)
Study completion: Jun 2011 (actual)
First posted: 21 Feb 2008 (estimated)
Results: Posted 25 Jun 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Rosuvastatin 20 mg	Experimental	Drug: RosuvastatinRosuvastatin 20 mg distributed in 2-week run-in period
Atorvastatin 40 mg	Active comparator	Drug: AtorvastatinAtorvastatin 40 mg distributed in 2-week run-in period
Rosuvastatin 40 mg	Experimental	Drug: RosuvastatinRosuvastatin 40 mg distributed in core 2-year study
Atorvastatin 80 mg	Active comparator	Drug: AtorvastatinAtorvastatin 80 mg distributed in core 2-year study

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RosuvastatinAlso: Crestorcapsule, oral, once daily	Drug	Rosuvastatin 20 mg, Rosuvastatin 40 mg
AtorvastatinAlso: Lipitorcapsule, oral, one daily	Drug	Atorvastatin 40 mg, Atorvastatin 80 mg

Primary outcome

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.

15 secondary outcomes

Numbers of Patients Showing Regression in PAV
Time frame: 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)
Numbers of Patients Showing Regression in TAV
Time frame: End of study (Week 104)
Total Cholesterol Blood Level
Time frame: 104 weeks
LDL-C Blood Level
Time frame: 104 weeks
HDL-C Blood Level
Time frame: 104 weeks
Triglycerides Blood Level
Time frame: 104 weeks
Non-HDL-C Blood Level
Time frame: 104 weeks
LDL-C/HDL-C Blood Level
Time frame: 104 weeks
Total Cholesterol/HDL-C Blood Level
Time frame: 104 weeks
Non-HDL-C/HDL-C Blood Level
Time frame: 104 weeks
Apolipoprotein B Blood Level
Time frame: 104 weeks
Apolipoprotein A-1 Blood Level
Time frame: 104 weeks
Apoliprotein B/Apolipoprotein A-1 Blood Level
Time frame: 104 weeks
VLDL-C During the 104 Week Treatment Period
Time frame: 104 weeks

Results and safety

Results posted to the registry on 25 Jun 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Rosuvastatin 20 mg	1,167	695
Atorvastatin 40 mg	1,166	690
Rosuvastatin 40 mg	0	0
Atorvastatin 80 mg	0	0

Primary outcome: Change From Baseline to End of Study (Week 104) in Percent Atheroma Volume (PAV)

Time frame: End of study (Week 104). Median (95% Confidence Interval). Unit: Percent change

Measure	Rosuvastatin 40 mg n = 520	Atorvastatin 80 mg n = 519
Value	-1.22 (-1.52 to -0.90)	-0.99 (-1.19 to -0.63)

Population analysed: Intent-to-Treat population (patients received at least one dose of study drug and had pre-study and post-study IVUS).

15 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Rosuvastatin 20 mg	21 of 783 (2.7%)	0 of 783 (0%)	Not reported
Atorvastatin 40 mg	25 of 795 (3.1%)	0 of 795 (0%)	Not reported
Rosuvastatin 40 mg	194 of 691 (28.1%)	210 of 691 (30.4%)	Not reported
Atorvastatin 80 mg	168 of 689 (24.4%)	213 of 689 (30.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25240453Puri 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.
Derived from this study: PubMed 24448227Puri 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.
Derived from this study: PubMed 24043299Puri 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.
Derived from this study: PubMed 22085316Nicholls 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.

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Coronary Artery Disease
Recruiting
A Prospective, Multicenter, Randomized Controlled Trial to Investigate the Value of Coronary CT Angiography in the Understanding and Management of Coronary Calcium (The Optimal Trial)
Cardiovascular Diseases, Myocardial Ischemia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Stephen J Nicholls, MBBS, PhD principal investigator

Cleveland Clinic Foundation, Cardiovascular Medicine

195 sites in 14 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rosuvastatin and Atorvastatin in people with Coronary Atherosclerosis, run by AstraZeneca at 195 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 195 sites in United States, Canada, Netherlands, France, Italy and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Jun 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline to End of Study (Week 104) in Percent Atheroma Volume (PAV) (time frame: End of study (Week 104)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00620542, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2012.