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

CompletadoFase 3ClinicalTrials.gov

ID: NCT00620542Tipo: INTERVENTIONALInicio: 1 de ene de 2008Fin estimado: 1 de jun de 2011

Traducción no disponible, mostrando original

Resumen

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.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 75 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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

Intervenciones

drug

Rosuvastatin

capsule, oral, once daily

drug

Atorvastatin

capsule, oral, one daily

Ubicaciones

Research Site

Buenos Aires, Buenos Aires, Argentina

Research Site

Cap. Fed., Buenos Aires, Argentina

Research Site

Ciudad de Buenos Aires, Buenos Aires, Argentina

Research Site

Corrientes, Corrientes Province, Argentina

Research Site

Córdoba, Córdoba Province, Argentina

Research Site

Rosario, Santa Fe-argentina, Argentina

Patrocinadores

PrincipalAstraZeneca

ColaboradorThe Cleveland Clinic

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