Rosuvastatin(CRESTOR)GALAXYProgramme.ppt

* Core slide The primary endpoint is the percentage change in the plaque volume from baseline (week 0) to the end of rosuvastatin treatment (week 76) (target lesion length of ≥6 mm is measured). Additional information on the secondary endpoints: change from baseline to end of treatment (week 76) in: plaque volume in target lesion plaque area at the same coronary artery cross-section where the maximum plaque area was found at baseline within the target lesion of plaque volume (absolute and percentage change) vascular cross-sectional lumen area and total vascular area at the same coronary artery cross-section where the maximum plaque area was found at baseline within the target lesion of plaque volume (absolute and percentage change) vascular lumen volume and total vascular volume in the target lesion (absolute and percentage change) change (%) from baseline to specified measured time points in TC, LDL-C, VLDL-C, HDL-C, nonHDL-C, RLP-C, ApoA-I, ApoA-II, Lp(a), small dense LDL, HDL-2, HDL-3 and the inflammatory marker hsCRP safety – adverse events, subjective symptoms/objective findings physical tests, blood tests, urinalysis, vital signs. Abbreviations hsCRP=high sensitivity C-reactive protein; TC=total cholesterol; LDL-C=low-density lipoprotein cholesterol; VLDL-C=very-low-density lipoprotein cholesterol; HDL-C=high-density lipoprotein cholesterol; RLP-C=remnant-like particle cholesterol; Apo=apolipoprotein; Lp(a)=lipoprotein (a) * Core slide Additional inclusion criterion: Patient has already undergone PCI for ≥1 lesion and completed IVUS measurement by the specified procedure in the lesion that has not undergone PCI, with measurements recorded. Abbreviations CHD=coronary heart disease; CAG=coronary angiography; PCI=percutaneous coronary intervention; LDL-C=low-density lipoprotein cholesterol; TC=total cholesterol; AHA=American Heart Association; IVUS=intravascular ultrasound * Core slide Additional information on exclusion criteria: Secondary hyperli