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 disease - SATUR

AstraZeneca AB0 sites1,300 target enrollmentNovember 26, 2007

DrugsCrestor 10mg Lipitor 40mg

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: AstraZeneca AB
Enrollment: 1300
Status: Active, not recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

November 26, 2007

End Date

June 1, 2011

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

AstraZeneca AB

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.
•Are the trial subjects under 18? no
•Number of subjects for this age range:

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.
•2\. Moderate or greater severity of congestive heart failure (CHF), or whose most recent determination of left ventricular ejection fraction (LVEF) is \<0\.35, by contrast left ventriculography, radionuclide ventriculography or echocardiography.
•3\. Clinically significant heart disease which, in the opinion of the Principal Investigator (or designee), is likely to require coronary bypass surgery, PCI, cardiac transplantation, surgical repair and/or replacement during the course of the study.
•4\. Uncontrolled hypertension at Visit 2, defined as either a resting diastolic blood pressure of ³100 mmHg or a resting systolic blood pressure of ³200 mmHg.
•5\. Known serious or hypersensitivity reactions to HMG\-CoA reductase inhibitors.
•6\. Triglyceride (TG) level ³500 mg/dL (5\.65 mmol/L) at screening.
•7\. Creatine kinase (CK) \>3 times the upper limit of the normal (ULN) range at screening.
•8\. Known major hematologic, neoplastic, metabolic, gastrointestinal or endocrine dysfunction which, in the judgment of the Investigator, may affect the patient’s ability to complete the study.
•9\. History of malignancy, except in patients who have been disease\-free \>5 years or whose only malignancy has been basal or squamous cell skin carcinoma.
•10\. Life\-threatening illness indicating the patient is not expected to survive for 104 weeks.