Qualitative and quantitative effects of aggressive lipid-lowering therapy on atherosclerosis: Evaluation of vulnerable plaque by 64-slice MD-CT

UMIN ID: UMIN000001602

Registered date:26/12/2008

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: Hypercholesterolemic patients with coronary plaque
• Date of first enrollment: 2008/06/01
• Target sample size: 50
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Rosuvastatin will be administered for 48 weeks at a dose of 5 mg/day (2 rosuvastatin 2.5 mg tablet or 1 rosuvastatin 5 mg tablet).

Outcome(s)

• Primary Outcome: Change of CT value of plaque at Week 48
• Secondary Outcome: 1)Rate of subjects with low density plaque (CT value <= 50) at Week 48 2)Percentage change of calcium score at Week 48 3)Change of rate of restenosis in blood vessel at Week 48 4)Change of remodeling index at Week 48 5)Percentage change of plaque volume at Week 48 6) Change of lipids (LDL-C, HDL-C, TG, LDL/HDL-C) at Week 48 7) Change of hs-CRP at Week 48 8) Relationship between changes of lipids (LDL-C, HDL-C, LDL-C/HDL-C) and CT value at Week 48

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1) Patients who have received statins within one month before the study entry 2) Patient who doesn't obtain accurate CT value (ex: plaque contains thrombus.) 3) Patients who need to receive other lipid-lowering drugs apart from the test drug 4) Patients with the fasting TG level of more than 400 mg/dL 5) Patients with uncontrolled hypertension (SBP >= 160mmHg or DBP >= 100mmHg) or patients with diabetes (HbA1c >= 8.0%) 6) Patients with familial hypercholesterolemia 7) Patients with secondary hyperlipidemia due to thyroid dysfunction, Cushing's syndrome, nephrotic syndrome, systemic lupus erythematosus, etc. 8) Patients with atrial fibrillation 9) Patients on treatment with cyclosporine 10) Patients currently receiving hemodialysis 11) Patients with a history of serious adverse effects or allergy to HMG-CoA reductase inhibitors 12) Patients with malignant tumor or doubtful malignant tumor, or patients with history of malignant tumor 13) Patients with active liver disease or hepatic dysfunction (ALT, AST, ALP levels more than 2.5 times the upper limit of normal, or a total bilirubin of more than 3.0 mg/dL) 14) Patients with the serum creatinine of more than 1.8 mg/dL 15) Patients with the serum CK level at least 3 times the upper limit of normal 16) Patients who can not take -blockers 17) Patients with confirmed pregnancy, possible pregnancy 18) Patients who underwent coronary PCI 19) Patients who are ineligible for any other reason in the opinion of the investigator

Related Information

• Primary Sponsor: Sakurabashi Watanabe Hospital
• Secondary Sponsor: PL Hospital Okamura Memorial Hospital Tokushima Prefectural Central Hospital Ichiriyama Imai Clinic
• Source(s) of Monetary Support: JAPAN VASCULAR DISEASE RESEARCH FOUNDATION