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CRESTOR Athero Imaging Head to Head IVUS Study (SATURN)

11. juli 2012 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

2333

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • 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
  • Belgia
      • Aalst, Belgia
        • Research Site
      • Brugge, Belgia
        • Research Site
      • Brussels, Belgia
        • Research Site
      • Charleroi, Belgia
        • Research Site
      • Genk, Belgia
        • Research Site
      • Leuven, Belgia
        • Research Site
  • Brasil
    • ES
      • Cariacica, ES, Brasil
        • Research Site
      • Vitoria, ES, Brasil
        • Research Site
    • GO
      • Goiania, GO, Brasil
        • Research Site
    • MG
      • Uberlandia, MG, Brasil
        • Research Site
    • MT
      • Cuiaba, MT, Brasil
        • Research Site
    • PR
      • Curitiba, PR, Brasil
        • Research Site
    • SP
      • Ribeirao Preto, SP, Brasil
        • Research Site
      • Sao Paulo, SP, Brasil
        • 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
  • Den russiske føderasjonen
      • Moscow, Den russiske føderasjonen
        • Research Site
      • Saint Petersburg, Den russiske føderasjonen
        • Research Site
      • Tomsk, Den russiske føderasjonen
        • Research Site
      • Tumen, Den russiske føderasjonen
        • Research Site
    • Moscow Region
      • Krasnogorsk, Moscow Region, Den russiske føderasjonen
        • Research Site
  • Forente stater
    • Alabama
      • Huntsville, Alabama, Forente stater
        • Research Site
    • California
      • Los Angeles, California, Forente stater
        • Research Site
      • Mountain View, California, Forente stater
        • Research Site
      • Sacramento, California, Forente stater
        • Research Site
      • San Diego, California, Forente stater
        • Research Site
      • Santa Rosa, California, Forente stater
        • Research Site
      • Torrance, California, Forente stater
        • Research Site
    • Colorado
      • Boulder, Colorado, Forente stater
        • Research Site
      • Greeley, Colorado, Forente stater
        • Research Site
      • Loveland, Colorado, Forente stater
        • Research Site
    • Connecticut
      • Farmington, Connecticut, Forente stater
        • Research Site
    • District of Columbia
      • Washington, District of Columbia, Forente stater
        • Research Site
    • Florida
      • Clearwater, Florida, Forente stater
        • Research Site
      • Ft Lauderdale, Florida, Forente stater
        • Research Site
      • Jacksonville, Florida, Forente stater
        • Research Site
      • Melbourne, Florida, Forente stater
        • Research Site
      • Miami, Florida, Forente stater
        • Research Site
      • Orlando, Florida, Forente stater
        • Research Site
      • Sarasota, Florida, Forente stater
        • Research Site
      • Tampa, Florida, Forente stater
        • Research Site
      • Winter Haven, Florida, Forente stater
        • Research Site
    • Georgia
      • Atlanta, Georgia, Forente stater
        • Research Site
      • Augusta, Georgia, Forente stater
        • Research Site
    • Indiana
      • Elkhart, Indiana, Forente stater
        • Research Site
      • Hammond, Indiana, Forente stater
        • Research Site
      • Indianapolis, Indiana, Forente stater
        • Research Site
      • Merrillville, Indiana, Forente stater
        • Research Site
      • Valparaiso, Indiana, Forente stater
        • Research Site
    • Iowa
      • Davenport, Iowa, Forente stater
        • Research Site
      • Iowa City, Iowa, Forente stater
        • Research Site
      • West Des Moines, Iowa, Forente stater
        • Research Site
    • Kentucky
      • Ashland, Kentucky, Forente stater
        • Research Site
      • Lexington, Kentucky, Forente stater
        • Research Site
      • Louisville, Kentucky, Forente stater
        • Research Site
    • Louisiana
      • Covington, Louisiana, Forente stater
        • Research Site
    • Maryland
      • Bethesda, Maryland, Forente stater
        • Research Site
      • Columbia, Maryland, Forente stater
        • Research Site
      • Takoma Park, Maryland, Forente stater
        • Research Site
    • Michigan
      • Bay City, Michigan, Forente stater
        • Research Site
      • Grand Blanc, Michigan, Forente stater
        • Research Site
      • Kalamazoo, Michigan, Forente stater
        • Research Site
      • Midland, Michigan, Forente stater
        • Research Site
      • Muskegon, Michigan, Forente stater
        • Research Site
      • Petoskey, Michigan, Forente stater
        • Research Site
      • Saginaw, Michigan, Forente stater
        • Research Site
      • Southfield, Michigan, Forente stater
        • Research Site
    • Minnesota
      • Duluth, Minnesota, Forente stater
        • Research Site
      • Minneapolis, Minnesota, Forente stater
        • Research Site
      • Rochester, Minnesota, Forente stater
        • Research Site
      • St Cloud, Minnesota, Forente stater
        • Research Site
      • St. Paul, Minnesota, Forente stater
        • Research Site
    • Missouri
      • Columbia, Missouri, Forente stater
        • Research Site
      • Kansas City, Missouri, Forente stater
        • Research Site
    • Montana
      • Missoula, Montana, Forente stater
        • Research Site
    • Nebraska
      • Lincoln, Nebraska, Forente stater
        • Research Site
      • Omaha, Nebraska, Forente stater
        • Research Site
    • New Jersey
      • New Brunswick, New Jersey, Forente stater
        • Research Site
      • Ridgewood, New Jersey, Forente stater
        • Research Site
    • New Mexico
      • Albuquerque, New Mexico, Forente stater
        • Research Site
    • New York
      • Buffalo, New York, Forente stater
        • Research Site
      • Johnson City, New York, Forente stater
        • Research Site
      • New York, New York, Forente stater
        • Research Site
      • Roslyn, New York, Forente stater
        • Research Site
      • Williamsville, New York, Forente stater
        • Research Site
    • North Carolina
      • Charlotte, North Carolina, Forente stater
        • Research Site
      • Gastonia, North Carolina, Forente stater
        • Research Site
      • Greensboro, North Carolina, Forente stater
        • Research Site
    • North Dakota
      • Fargo, North Dakota, Forente stater
        • Research Site
    • Ohio
      • Cincinnati, Ohio, Forente stater
        • Research Site
      • Cleveland, Ohio, Forente stater
        • Research Site
      • Columbus, Ohio, Forente stater
        • Research Site
      • Elyria, Ohio, Forente stater
        • Research Site
      • Kettering, Ohio, Forente stater
        • Research Site
      • Middleburg Heights, Ohio, Forente stater
        • Research Site
      • Perrysburg, Ohio, Forente stater
        • Research Site
    • Oklahoma
      • Oklahoma City, Oklahoma, Forente stater
        • Research Site
      • Tulsa, Oklahoma, Forente stater
        • Research Site
    • Oregon
      • Bend, Oregon, Forente stater
        • Research Site
      • Eugene, Oregon, Forente stater
        • Research Site
      • Hillsboro, Oregon, Forente stater
        • Research Site
    • Pennsylvania
      • Danville, Pennsylvania, Forente stater
        • Research Site
      • Doylestown, Pennsylvania, Forente stater
        • Research Site
      • Hershey, Pennsylvania, Forente stater
        • Research Site
      • Philadelphia, Pennsylvania, Forente stater
        • Research Site
      • Wormleysburg, Pennsylvania, Forente stater
        • Research Site
    • South Carolina
      • Charleston, South Carolina, Forente stater
        • Research Site
    • Tennessee
      • Chattanooga, Tennessee, Forente stater
        • Research Site
      • Germantown, Tennessee, Forente stater
        • Research Site
      • Knoxville, Tennessee, Forente stater
        • Research Site
      • Memphis, Tennessee, Forente stater
        • Research Site
      • Oak Ridge, Tennessee, Forente stater
        • Research Site
    • Texas
      • Dallas, Texas, Forente stater
        • Research Site
      • San Antonio, Texas, Forente stater
        • Research Site
    • Virginia
      • Charlottesville, Virginia, Forente stater
        • Research Site
    • Washington
      • Bellevue, Washington, Forente stater
        • Research Site
      • Spokane, Washington, Forente stater
        • Research Site
      • Tacoma, Washington, Forente stater
        • Research Site
  • Frankrike
      • Besancon, Frankrike
        • Research Site
      • Bron, Frankrike
        • Research Site
      • Creteil, Frankrike
        • Research Site
      • Le Plessis-robinson, Frankrike
        • Research Site
      • Marseille, Frankrike
        • Research Site
      • Pessac, Frankrike
        • Research Site
      • Quincy Sous Senart, Frankrike
        • Research Site
      • Strasbourg, Frankrike
        • Research Site
      • Toulouse, Frankrike
        • Research Site
  • Italia
      • Novara, Italia
        • Research Site
      • Roma, Italia
        • Research Site
    • AR
      • Arezzo, AR, Italia
        • Research Site
    • MI
      • Milano, MI, Italia
        • Research Site
      • Rozzano, MI, Italia
        • Research Site
    • Milano
      • Sesto San Giovanni, Milano, Italia
        • Research Site
    • PR
      • Parma, PR, Italia
        • Research Site
    • SI
      • Siena, SI, Italia
        • Research Site
    • UD
      • Udine, UD, Italia
        • 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
  • Nederland
      • Alkmaar, Nederland
        • Research Site
      • Amsterdam, Nederland
        • Research Site
      • Breda, Nederland
        • Research Site
      • Eindhoven, Nederland
        • Research Site
      • Enschede, Nederland
        • Research Site
      • Leeuwarden, Nederland
        • Research Site
      • Nieuwegein, Nederland
        • Research Site
      • Nijmegen, Nederland
        • Research Site
      • Rotterdam, Nederland
        • Research Site
      • Zwolle, Nederland
        • Research Site
  • Polen
      • Bialystok, Polen
        • Research Site
      • Katowice, Polen
        • Research Site
      • Kedzierzyn Kozle, Polen
        • Research Site
      • Krakow, Polen
        • Research Site
      • Lodz, Polen
        • Research Site
      • Poznan, Polen
        • Research Site
      • Warszawa, Polen
        • Research Site
      • Zabrze, Polen
        • Research Site
  • Spania
    • Andalucia
      • Malaga, Andalucia, Spania
        • Research Site
    • Asturias
      • Oviedo, Asturias, Spania
        • Research Site
    • Cataluna
      • Badalona, Cataluna, Spania
        • Research Site
      • Barcelona, Cataluna, Spania
        • Research Site
    • Comunidad Valenciana
      • Alicante, Comunidad Valenciana, Spania
        • Research Site
    • Comunidad de Madrid
      • Madrid, Comunidad de Madrid, Spania
        • Research Site
  • Ungarn
      • Budapest, Ungarn
        • Research Site
      • Szged, Ungarn
        • Research Site

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 75 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Rosuvastatin 20 mg
Rosuvastatin 20 mg distributed in 2-week run-in period
Legemiddel: Rosuvastatin
capsule, oral, once daily
Andre navn:
  • Crestor
Aktiv komparator: Atorvastatin 40 mg
Atorvastatin 40 mg distributed in 2-week run-in period
Legemiddel: Atorvastatin
capsule, oral, one daily
Andre navn:
  • Lipitor
Eksperimentell: Rosuvastatin 40 mg
Rosuvastatin 40 mg distributed in core 2-year study
Legemiddel: Rosuvastatin
capsule, oral, once daily
Andre navn:
  • Crestor
Aktiv komparator: Atorvastatin 80 mg
Atorvastatin 80 mg distributed in core 2-year study
Legemiddel: Atorvastatin
capsule, oral, one daily
Andre navn:
  • Lipitor

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change From Baseline to End of Study (Week 104) in Percent Atheroma Volume (PAV)
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Numbers of Patients Showing Regression in PAV
Tidsramme: 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)
Tidsramme: 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
Tidsramme: End of study (Week 104)
Regression defined as a change from baseline in TAV < 0
End of study (Week 104)
Total Cholesterol Blood Level
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

AstraZeneca

Samarbeidspartnere

The Cleveland Clinic

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. januar 2008

Primær fullføring (Faktiske)

1. juni 2011

Studiet fullført (Faktiske)

1. juni 2011

Datoer for studieregistrering

Først innsendt

6. februar 2008

Først innsendt som oppfylte QC-kriteriene

20. februar 2008

Først lagt ut (Anslag)

21. februar 2008

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

16. juli 2012

Siste oppdatering sendt inn som oppfylte QC-kriteriene

11. juli 2012

Sist bekreftet

1. juli 2012

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • D356IC00001
  • 2007-004000-13

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere