The purpose of this study is to compare the effects of pravastatin and rosuvastatin on coronary plaque characteristics in patients with stable angina pectoris.
Previous mega trials have demonstrated that lipid-lowering therapy with HMG-CoA reductase inhibitors in individuals with high risk of cardiovascular disease reduces the incidence of coronary heart disease. NCEP ATP-III has suggested the advantage of more intensive lipid lowering therapy with a goal of reducing LDL-C below 70 mg/dL for such patients categorized as very high risk. In Japan, Japan Atherosclerosis Society (JAS) Guidelines for Diagnosis and Treatment of Atherosclerotic Cardiovascular Diseases 2002 have recommended that an LDL-C goal for patients with coronary heart disease (CHD) should be below 100 mg/dL. However, there is no satisfactory evidence whether the investigators need to lower LDL-C level less than the 70mg/dL or not in Japanese population. Recently, research on diagnosis of coronary plaque has shown significant advances. The REVERSAL study in patients with a history of CHD, by diagnosis with intravascular ultrasound (IVUS), suggested that intensive lipid lowering therapy with atorvastatin (80 mg/day) was associated with no growth of plaque (-0.4% compared to baseline), whereas therapy with pravastatin (40 mg/day) showed a slight increase (2.7%) in plaque volume over 18 months in Western population. MEGA study has shown that lipid lowering therapy with pravastatin (10-20 mg/day) was associated with a 33% reduction in coronary heart disease incidence as the primary prevention in Japanese patients. However, the effect of lipid lowering therapy in secondary prevention of cardiovascular events is unknown. Relative plaque regression rate between intensive and moderate lipid lowering therapy would clarify the ideal level of target LDL-C in Japanese population. Furthermore, the different effect on coronary plaque between pravastatin and rosuvastatin which have different LDL-C lowering effect and different affinity to arterial tissue would determine the superior lipid lowering regimen to affect coronary plaque volume. Therefore, the aim of the present study is to evaluate whether there would be lipid lowering therapy differences in terms of the composition of coronary artery plaques in patients with stable angina pectoris (SAP) using integrated backscatter intravascular ultrasound (IB-IVUS) and optical coherence tomography (OCT).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
1. Active Comparator Intervention: Drug: pravastatin 10mg/day or 20mg/day 2. Active Comparator Intervention: Drug: rosuvastatin 20mg/day
Yokohama City University Medical Center
Yokohama, Japan
RECRUITINGthe percent change in fibrous cap thickness by optical coherence tomography
the percent change in fibrous cap thickness by optical coherence tomography
Time frame: 9-11 months
the percent change and the absolute change from baseline in coronary plaque volume and IB signal obtained by IB-IVUS
the percent change and the absolute change from baseline in coronary plaque volume, the percent change in integrated backscatter signal obtained by integrated backscatter IVUS
Time frame: 9-11 months
the absolute change from baseline in number of TCFA and plaque rupture, and in neointima thickness on stent struts by OCT
the absolute change from baseline in number of TCFA, plaque rupture, thrombus, calcification, and in neointima thickness on stent struts by optical coherence tomography
Time frame: 9-11 months
the percent change and the absolute change from baseline in total cholesterol and LDL cholesterol
the percent change and the absolute change from baseline in total cholesterol and low-density lipoprotein cholesterol
Time frame: 9-11 months
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