Patients with coronary artery disease MedDRA version: 9.1 Level: LLT Classification code 10011078 Term: Coronary artery disease
Conditions
Interventions
Trade Name: CRESTOR*28CPR RIV 40MG
Pharmaceutical Form: Tablet
INN or Proposed INN: Rosuvastatin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Trade Name: LI
Sponsors
ASTRAZENECA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed written informed consent 2. Men or women 18 to 75 years of age. 3. Women must be non-lactating, not of childbearing potential or using a reliable method of birth control considered suitable by the Investigator. 4. Clinical indication for coronary angiography. 5. Willing study procedures: adherence to lipid-lowering diet, study visits, fasting blood draws and compliance with study treatment regimen. 3. Target Coronary Artery: Must be accessible to the IVUS catheter. Must have a 50%, and provided that the branch in question is not, and will not be, a target for percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) during the course of the study. Has not sustained a myocardial infarction (MI). Has not undergone prior PCI or CABG surgery. The target vessel is not currently a candidate for intervention or a likely candidate for intervention over the next 24 months. The target vessel may not be a bypass graft. . The target vessel may not be a bypassed vessel. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients must not have been treated with lipid-lowering medications for more than 3 months in the past 12 months. .Patients who have symptoms consistent with 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, . Known major hematologic, neoplastic, metabolic, gastrointestinal or endocrine dysfunction which, in the judgment of the Investigator . 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. . Life-threatening illness indicating the patient is not expected to survive for 104 weeks. . Unreliability as a study participant based on the Investigator?s knowledge of the patient, such as drug or alcohol abuse. . Uncontrolled diabetes, defined as glycosylated hemoglobin (HbA1C) >10% at screening. . Active liver disease or hepatic dysfunction, as determined by aspartate aminotransferase (AST [SGOT]), alanine aminotransferase (ALT [SGPT]) or bilirubin levels ≥1.5 x ULN at screening, because of the potential of statins to cause disturbances in liver function Secondary causes of hyperlipoproteinemia, such as uncontrolled primary hypothyroidism (defined as thyroid stimulating hormone [TSH] ≥1.5 x ULN), nephrotic syndrome, and/or renal dysfunction (serum creatinine ≥2.0 mg/dL [177 μmol/L]) at screening. . Coronary artery bypass surgery <6 weeks prior to the qualifying IVUS.
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: The secondary objectives of this study are: 1. To determine whether 104 weeks (24 months) of treatment with rosuvastatin 40mg or atorvastatin 80mg shows regression of PAV in the targeted coronary artery as measured by IVUS. 2. To compare the effects of rosuvastatin 40mg with atorvastatin 80mg on the total atheroma volume (TAV) in the targeted coronary artery as measured by IVUS. 3. To compare the effects of rosuvastatin 40mg with atorvastatin 80mg on lipid and lipoprotein metabolism. 4. To assess the safety and tolerability of rosuvastatin 40mg and atorvastatin 80mg during the 104 weeks of 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