Acute Coronary Syndrome patients who have thin-cap fibroatheroma in non-culprit lesion
Conditions
Interventions
Rosuvastatin 2.5mg-20mg 6 months
Sponsors
Yamaguchi University Graduate School of Medicine Department of Medicine and Clinical Science
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The patients to fill the following standard, who have undergone PCI to acute coronary syndromes (ACS), who have the past of unstable angina pectoris(UAP) among hypercholesterolemia patients on standby PCI enforcement. 1) Patients with LDL-C >= 100 mg/dL(treated group) and < 140 mg/dL(untreated group) 2) Patients aged 20 years over, outpatient, hospitalization, and sex pretermission. 3) Patient to whom existence of TCFA was confirmed by FD-OCT. 4) Patients who are able to submit written consent agreement by themselves. 5) 20-year-old or more man and woman of PCI enforcement hypercholesterolemia patient who has coronary artery disease.
Exclusion criteria
Exclusion criteria: 1) Patient who needs lipid-lowering therapy other than research medicine during study period. 2)Patients with homozygous familial hypercholesterolemia,secondary hypercholesterolemia. 3) Patients with serum triglyceride > 400 mg/dL 4) Patient who has previous history of hypersensitivity for Statin. 5) Patients with hepatic function disorder (AST/ALT>= 100 IU/L, total bilirubin > 2.5mg/dL) 6) Patients with renal function disorder (serum creatinine >= 2.0mg/dL or creatinine clearance < 30mL/min/1.73m2) 7) Patients with serum CK > 500 IU/L 8) Patients receiving cyclosporine. 9) Pregnant women and women suspected of being pregnant. 10) Patients with hypothyroidism, hereditary muscular diseases (muscular dystrophy, etc.) or familial history of these diseases. 11)Patients with history of drug-related muscular disorder. 12) Patients with drug abuse or alcoholism. 13) Patient who has received treatment with medicines other than research medicine. Though using the medicine together other than the research medicine are enabled during this study period.The usage and the dosage are assumed to be no change during this study period. Statin other than research medicine, fibrate, cholesterol transporter inhibitor, and cyclosporines
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| # Change of serum lipid: LDL-C change rate, TG change rate, HDL-C change rate, LDL-C/HDL-C change rate, non-HDL-C change rate # Relation between change of coronary fibrous-cap thickness with OCT and serum lipid # Change of coronary artery plaque CT value by MDCT # Relation between thickness change and serum lipid of coronary artery plaque CT value by OCT # Coronary artery plaque CT value change judged MDCT and relation to change of OCT opinion | — |
Primary
| Measure | Time frame |
|---|---|
| Change of coronary fibrous-cap thickness of 6 months treatment with rosuvastatin. | — |
Countries
Japan
Contacts
Public ContactTakayuki Okamura
Yamaguchi University Graduate School of Medicine Department of Medicine and Clinical Science
Outcome results
None listed