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CRESTOR Athero Imaging Head to Head IVUS Study (SATURN)

11 luglio 2012 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

2333

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 75 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Rosuvastatin 20 mg
Rosuvastatin 20 mg distributed in 2-week run-in period
Droga: Rosuvastatin
capsule, oral, once daily
Altri nomi:
  • Crestor
Comparatore attivo: Atorvastatin 40 mg
Atorvastatin 40 mg distributed in 2-week run-in period
Droga: Atorvastatin
capsule, oral, one daily
Altri nomi:
  • Lipitore
Sperimentale: Rosuvastatin 40 mg
Rosuvastatin 40 mg distributed in core 2-year study
Droga: Rosuvastatin
capsule, oral, once daily
Altri nomi:
  • Crestor
Comparatore attivo: Atorvastatin 80 mg
Atorvastatin 80 mg distributed in core 2-year study
Droga: Atorvastatin
capsule, oral, one daily
Altri nomi:
  • Lipitore

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change From Baseline to End of Study (Week 104) in Percent Atheroma Volume (PAV)
Lasso di tempo: 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)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Numbers of Patients Showing Regression in PAV
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: End of study (Week 104)
Regression defined as a change from baseline in TAV < 0
End of study (Week 104)
Total Cholesterol Blood Level
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

AstraZeneca

Collaboratori

The Cleveland Clinic

Investigatori

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

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 gennaio 2008

Completamento primario (Effettivo)

1 giugno 2011

Completamento dello studio (Effettivo)

1 giugno 2011

Date di iscrizione allo studio

Primo inviato

6 febbraio 2008

Primo inviato che soddisfa i criteri di controllo qualità

20 febbraio 2008

Primo Inserito (Stima)

21 febbraio 2008

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

16 luglio 2012

Ultimo aggiornamento inviato che soddisfa i criteri QC

11 luglio 2012

Ultimo verificato

1 luglio 2012

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • D356IC00001
  • 2007-004000-13

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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