Hypercholesterolemic patients with AMI
Conditions
Interventions
Rosuvastatin 10mg/day (n=60) (Starting dose: 5mg/day)
Rosuvastatin 2.5mg/day (n=60)
Sponsors
Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients meeting the following inclusion criteria will be included in the study: 1) Successful PCI for AMI 2) Hypercholesterolmia (LDL-C > 100mg/dL) 3) Giving voluntary written consent to participate in the study 4) 20 years old or older
Exclusion criteria
Exclusion criteria: Patients meeting the following criteria will be excluded from the study: 1) Administered statin within three month at the registration 2) Severe hypertension (SBP>=180 mmHg or DBP>=110 mmHg) 3) Familial hypercholesterolemia 4) Serum triglyceride level>=400 mg/dL 5) Prior onset of cardiovascular or cerebrovascular disease within 6 months before registration of this study 6) Hypersensitivity to statins 7) History of drug-induced myopathy 8) Active liver disease or elevated liver enzymes (ALT or AST > 3 times upper limit of normal [ULN], or bilirubin > 2 times ULN) 9) Nephrotic syndrome or renal dysfunction (creatinine clearance <30 mL/min/1.73 m2 or serum creatinine >2.0 mg/dL) 10) Administered cyclosporin 11) Serious concurrent disease such as malignancy, or patients with severely limited lifespan 12) Pregnant 13) Judged by the investigators to be ineligible for participation in the study for any other reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percent change of MMPs at 24 weeks after administration | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The change and the changes rate in LDL-C, HDL-C, TG, LDL-C/HDL-C ratio at 1day, 4weeks, and 24 weeks after administration. 2. The change and the changes rate of inflammatory markers and cardiac markers at 1day, 4weeks, and 24 weeks after administration. 3. The change and the changes rate of inflammatory markers in the aortic root and the coronary sinus at 24 weeks after administration. 4. The change of the plaque volume and stabilization at 24 weeks after administration. 5. Correlation between the lipid parameters, inflammatory markers, and other parameters. 6. Achievement rates of lipid parameters according to guidelines. 7. Incidence of cerebro-cardiovascular events. 8. Incidence and types of adverse events. | — |
Countries
Japan
Contacts
Public ContactKoichiro Fujisue
Graduate School of Medical Sciences, Kumamoto University Department of Cardiovascular Medicine
Outcome results
None listed