Biomarker and Imaging Study to assess the ability of high doses rosuvastatin to decrease artherosclerosis in coronary arteries.

More than half of all acute coronary syndromes (ACS) are caused by a
rupture of vulnerable atherosclerotic plaque, which is characterized by
the presence of a thin inflamed fibrous cap and a large necrotic core
pool. Intravascular ultrasound-virtual histology (IVUS-VH) allows tissue
characterization of four different plaque compositions, such as fibrous,
fibro-fatty, dense calcified and necrotic core. Although a high dosage
statin reduces coronary plaque size and necrotic core in carotid arteries,
it remains unknown whether there is a similar effect on the necrotic core
present in coronary atherosclerotic plaque. The IBIS-3 study is a
single-center, non-randomized study designed to evaluate the ability of a
high dose rosuvastatin in reducing the necrotic core of a non-intervened
coronary segment assessed in vivo with IVUS-VH within 12-months (primary
endpoint).

A high dose of rosuvastatin significantly decreases or halt the progress of the necrotic core volume present in a non-intervened coronary segment as assessed by IVUS-VH.

Baseline procedure, followed by follow-up at 2, 6 and 12 months. Angiographic follow-up, including IVUS-Virtual Histology (VH) and LipiScan assessments at 12 month.

1. Off-line IVUS-VH of one ‘study vessel’ at baseline and 52 weeks follow-up;

2. LipiScan examination of the ‘study-vessel’ at baseline and 52 weeks follow-up;

3. Blood samples for lipid profile at baseline and 52 weeks follow-up (hs-CRP, genetic, SNP, RNA, proteomic and lipidomic analysis as well as cellular and functional analysis will be obtained);

4. Rosuvastatin 40 mg (uptitrated within 30 days) for 12 months.