CRESTOR Athero Imaging Head to Head IVUS Study

Coronary Atherosclerosis Clinical Trial

— SATURN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00620542
• Other study ID #: D356IC00001
• Secondary ID: 2007-004000-13
• Status: Completed
• Phase: Phase 3
• First received: February 6, 2008
• Last updated: July 11, 2012
• Start date: January 2008
• Est. completion date: June 2011

Study information

• Verified date: July 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods AdministrationArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaBelgium: Ministry of Social Affairs, Public Health and the EnvironmentCanada: Health CanadaFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Italy: Ministry of HealthMexico: Ministry of HealthNetherlands: Medicines Evaluation Board (MEB)Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsSpain: Spanish Agency of MedicinesUnited States: Food and Drug Administration
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2333
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atherosclerosis
• Coronary Artery Disease
• Coronary Atherosclerosis
• Myocardial Ischemia

Intervention

Drug:
• Rosuvastatin
capsule, oral, once daily
• Atorvastatin
capsule, oral, one daily

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	The Cleveland Clinic

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Brazil,  Canada,  France,  Hungary,  Italy,  Mexico,  Netherlands,  Poland,  Russian Federation,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline to End of Study (Week 104) in Percent Atheroma Volume (PAV)	Change in PAV computed as PAV(Week 104)-PAV(baseline) where PAV is calculated as: [sum(EEMcsa-LUMENcsa)/sum EEMcsa]*100 where EEMcsa is the cross-sectional area of the external elastic membrane and LUMENcsa is the cross-sectional area of the lumen, as measured by intravascular ultrasound IVUS of a coronary artery in patients with CAD.	End of study (Week 104)	No
Secondary	Numbers of Patients Showing Regression in PAV	Regression defined as a change from baseline in PAV < 0	End of study (Week 104)	No
Secondary	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.	End of study (Week 104)	No
Secondary	Numbers of Patients Showing Regression in TAV	Regression defined as a change from baseline in TAV < 0	End of study (Week 104)	No
Secondary	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.	104 weeks	No
Secondary	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.	104 weeks	No
Secondary	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.	104 weeks	No
Secondary	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.	104 weeks	No
Secondary	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.	104 weeks	No
Secondary	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.	104 weeks	No
Secondary	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.	104 weeks	No
Secondary	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.	104 weeks	No
Secondary	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.	104 weeks	No
Secondary	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.	104 weeks	No
Secondary	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.	104 weeks	No
Secondary	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.	104 weeks	No