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Effect of Rosuvastatin therapy on coronary fibrous-cap thickness in patients with acute coronary syndrome : Assessment by frequencey domain optical coherence tomography study

Not Applicable
Conditions
Acute Coronary Syndrome patients who have thin-cap fibroatheroma in non-culprit lesion
Registration Number
JPRN-UMIN000011719
Lead Sponsor
Yamaguchi University Graduate School of Medicine Department of Medicine and Clinical Science
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
20
Inclusion Criteria

Not provided

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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Change of coronary fibrous-cap thickness of 6 months treatment with rosuvastatin.
Secondary Outcome Measures
NameTimeMethod
# 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
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