Coronary Atheroma -- The current trial will study patients who have a clinical indication for coronary catheterization and who have coronary artery disease.
Conditions
Interventions
Trade Name: Crestor 20mg
Product Name: Rosuvastatin capsules 20mg
Pharmaceutical Form: Capsule*
INN or Proposed INN: rosuvastatin calcium
CAS Number: 147098-20-2
Current Sponsor code: AZD4522
Concentr
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion 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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 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. 11. Unreliability as a study participant based on the Investigator’s knowledge of the patient, such as drug or alcohol abuse. 12. Participation in any investigational drug or device study within 30 days prior to study entry or expectation to participate in any other investigational drug or device study during the course of this study. Patients who withdraw from this study for any reason cannot re-enter the study. 13. Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the study site). 14. Anticipated requirement of the use during the study of any medication listed in the Prohibited Medications Section (Table 3). 15. Uncontrolled diabetes, defined as glycosylated hemoglobin (HbA1C) >10% at screening. 16. Active liver disease or hepatic dysfunction, as determined by aspartate aminotransferase (AST [SGOT]), alanine aminotransferase (ALT [SGPT]) or bilirubin levels ³1.5 x ULN at screening. 17. Secondary causes of hyperlipoproteinemia, such as uncontrolled primary hypothyroidism (defined as thyroid stimulating hormone [TSH] ³1.5 x ULN), nephrotic syndrome, and/or renal dysfunction (serum creatinine ³2.0 mg/dL [177 mmol/L]) at screening. 18. Coronary artery bypass surgery <6 weeks prior to the qualifying IVUS. 19. Significant medical or psychological condition that, in the opinion of the Investigator, would compromise the patient’s safety or successful participation in the study. 20. Baseline IVUS study determined to be of unacceptable quality by the IVUS core laboratory.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to compare the effects of rosuvastatin 40mg with atorvastatin 80mg on the percent atheroma volume (PAV) of a coronary artery as measured by intravascular ultrasound (IVUS) imaging following 104 weeks of treatment in patients with coronary artery disease (CAD).;Secondary Objective: Following 104 weeks of treatment in patients with CAD, the secondary efficacy objectives of the study are: · to determine whether rosuvastatin 40mg or atorvastatin 80mg shows regression of PAV in the targeted coronary artery as measured by IVUS. · to compare the effects of rosuvastatin 40mg with atorvastatin 80mg on the total atheroma volume (TAV) of the targeted coronary artery as measured by IVUS. · to compare the effects of rosuvastatin 40mg with atorvastatin 80mg on lipid and lipoprotein metabolism. The safety objective (secondary) is to assess the safety and tolerability of rosuvastatin 40mg and atorvastatin 80mg during the 104 week treatment in patients with CAD. ;Primary end point(s): The nominal change (end of treatment minus pre-treatment) in percent atheroma volume (PAV) in a = 40 mm segment of one targeted (imaged) coronary artery for all anatomically comparable slices (end of treatment and pre-treatment), as measured by IVUS. | — |
Countries
Belgium, France, Hungary, Italy, Netherlands, Spain
Outcome results
None listed