EUCTR2007-004000-13-ES
Active, not recruiting
Phase 1
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 40mg or atorvastatin 80mg on atherosclerotic disease burden as measured by intravascular ultrasound in patients with coronary artery diseaseEstudio del ateroma coronario mediante ultrasonido intravascular: efecto de la rosuvastatina versus atorvastatina.Estudio en Fase IIIb de 104 semanas, randomizado, doble ciego, de grupos paralelos, multicéntrico que compara los efectos del tratamiento con rosuvastatina 40 mg o atorvastatina 80 mg sobre la carga de la enfermedad aterosclerótica, medida por ultrasonido intravascular en pacientes con enfermedad arterial coronaria. - SATUR
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Coronary Atheroma -- The current trial will study patients who have a clinical indication for coronary catheterization and who have coronary artery disease. Ateroma coronario - este ensayo estudiará a pacientes con una indicación clínica de cateterización coronaria y con enfermedad arterial coronaria
- Sponsor
- AstraZeneca AB
- Enrollment
- 1300
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Signed written informed consent to participate in the study.
- •2\.Men or women 18 to 75 years of age.
- •3\.Women must be non\-lactating, not of childbearing potential (1 year post\-menopausal or surgically sterilized \[total hysterectomy, bilateral tubal ligation, bilateral oophorectomy]) or using a reliable method of birth control (eg, condoms with spermicide) considered suitable by the Investigator.
- •4\.Clinical indication for coronary angiography.
- •5\.Willing to follow all study procedures including adherence to lipid\-lowering diet, study visits, fasting blood draws and compliance with study treatment regimen.
- •6\.For patients with no statin therapy in the past 4 weeks: LDL\-C levels \> 100 mg/dL (2\.6 mmol/L)
- •For patients on statin therapy in the past 4 weeks: LDL\-C levels \> 80 mg/dL (2\.08 mmol/L)
- •7\.Patients will be randomized to receive pre\-treatment with either rosuvastatin 20 mg/d or atorvastatin 40 mg/d. All patients must attain LDL\-C levels of \<116 mg/dL (3\.0 mmol/L) and triglyeride levels \<500 mg/dL (5\.65 mmol/L) at Visit 2, following 2 weeks of rosuvastatin 20 mg/d or atorvastatin 40 mg/d. This is to make it highly likely that all patients will achieve adequate LDL\-C levels when randomized to either treatment arm, thus eliminating the need for rescue medication.
- •Angiographic Inclusion Criteria:
- •1\.Entire coronary circulation: Must have angiographic evidence of CAD, as defined by at least 1 lesion in a native coronary artery that has \>20% reduction in lumen diameter by angiographic visual estimation.
Exclusion Criteria
- •1\.Patients must not have been treated with the following lipid\-lowering medications for more than 3 months in the past 12 months:
- •\-rosuvastatin, any dose
- •\-atorvastatin 40 or 80mg
- •\-simvastatin 80mg
- •\-Vytorin, any dose
- •\-ezetimibe in combination with any statin
- •\-Fibrates, any dose
- •\-Niacin/nicotinic acid 250mg or more
- •\-Omega III fatty acids 1000mg or more
- •Longer periods of treatment are not permitted because of the potential effects of such therapy on coronary atherosclerosis.
Outcomes
Primary Outcomes
Not specified
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