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CRESTOR Athero Imaging Head to Head IVUS Study (SATURN)

11. juli 2012 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

2333

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Rosuvastatin 20 mg
Rosuvastatin 20 mg distributed in 2-week run-in period
Medicin: Rosuvastatin
capsule, oral, once daily
Andre navne:
  • Crestor
Aktiv komparator: Atorvastatin 40 mg
Atorvastatin 40 mg distributed in 2-week run-in period
Medicin: Atorvastatin
capsule, oral, one daily
Andre navne:
  • Lipitor
Eksperimentel: Rosuvastatin 40 mg
Rosuvastatin 40 mg distributed in core 2-year study
Medicin: Rosuvastatin
capsule, oral, once daily
Andre navne:
  • Crestor
Aktiv komparator: Atorvastatin 80 mg
Atorvastatin 80 mg distributed in core 2-year study
Medicin: Atorvastatin
capsule, oral, one daily
Andre navne:
  • Lipitor

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

AstraZeneca

Samarbejdspartnere

The Cleveland Clinic

Efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. januar 2008

Primær færdiggørelse (Faktiske)

1. juni 2011

Studieafslutning (Faktiske)

1. juni 2011

Datoer for studieregistrering

Først indsendt

6. februar 2008

Først indsendt, der opfyldte QC-kriterier

20. februar 2008

Først opslået (Skøn)

21. februar 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

16. juli 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. juli 2012

Sidst verificeret

1. juli 2012

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • D356IC00001
  • 2007-004000-13

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Koronar aterosklerose

  • IRCCS Policlinico S. Donato
    Rekruttering
    Anomal aorta-oprindelse af koronararterie (AAOCA)
    Anomalous aorta origin of the coronary artery (AAOCA)
    Italien
  • IRCCS Policlinico S. Donato
    University of Pavia; University of Naples; The Mediterranean Institute for...
    Rekruttering
    Fremskynd diagnosticering og evaluering af anomaløs kranspulsåre fra aorta (SMART)
    Myokardieiskæmi | Pludselig hjertedød | Anomal koronararterieoprindelse | Anomal koronararterie, der opstår fra den modsatte sinus | Anomal koronararterie med aorta-oprindelse og forløb mellem de store arterier | Anomalous aorta origin of the coronary artery (AAOCA) | Myokardieiskæmi, Angina Pectoris og andre forhold
    Italien

Kliniske forsøg med Rosuvastatin

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Ghana

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner