Intensive LOwering of BlOod low-density lipoprotein ChOlesterol with statin + ezetimibe therapy improves cardiac function after Percutaneous coronary intervention in patients with coronary stenting in Fukuoka-II (LOBOCOP-II)

UMIN ID: UMIN000001782

Registered date:23/03/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Ischemic heart disease
• Date of first enrollment: 2009/04/01
• Target sample size: 200
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

From administration of the atorvastatin(10mg/day) and ezetimibe(10mg/day) to follow up coronary arteriography by PCI(after 6-9 months). Blood sampling is performed before PCI and after PCI at day 1, 7 and 6-9 months.
From administration of the atorvastatin(10mg/day) to follow up coronary arteriography by PCI(after 6-9 months). Blood sampling is performed before PCI and after PCI at day 1, 7 and 6-9 months.

Outcome(s)

• Primary Outcome: Evaluation of %DS by QCA(6-9 months after PCI) %DS:percent diameter stenosis QCA:quantitative coronary angiography
• Secondary Outcome: Plaque volume by IVUS, Plaque area by MSCT, LV blood flow by the contrast echocardiography, the plaque by the carotid echo, a vascular endothelium function by FMD, the evaluation of the change of ,adhesion molecule. The measurement of blood levels of chemokine, MMP(Matrix Metalloproteinase), TIMP(Tissue Inhibitor of Metalloproteinase), adiponectine. Major adverse cardiac events (MACE) and target lesion revascularization (TLR) during follow up.

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: 100years-old
• Gender: Male and Female
• Exclude criteria: Patients with familial hyperlipidaemia, a severe liver dysfunction (AST / ALT more than the double of the reference value), severe renal dysfunction (Cr more than 2mg/dl), diabetes mellitus inadequate control (HbA1c more than 7mg/dl), the possibility of pregnancy, and a history of hypersensitivity for the ingredient of the study drug are excluded from the study.The patients who fall under the contraindication of the study drug and the inappropriate patients by doctor's judgement are also excluded.

Related Information

• Primary Sponsor: Heart/vascular internal medicine,fukuoka university
• Secondary Sponsor: none
• Source(s) of Monetary Support: none,none