Patients with acute coronary syndrome with a history of having undergone successful percutaneous coronary intervention
Conditions
Interventions
4 mg pitavastatin daily started within 24 hours of PCI and administered for a period of 36 weeks
4 mg pitavastatin daily administered from 3 weeks to 36 weeks after PCI
Sponsors
Department of Cardiovascular Medicine, Wakayama Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with acute coronary syndrome (defined as ST-segment elevation acute myocardial infarction, non-ST-segment elevation myocardial infarction or unstable angina). Patients who meet at least two of the following criteria within 7 days prior to admission: 1. ECG changes of acute coronary ischemia 2. SerumCK level more than 2 times the upper limit of normal, serum CK-MB or troponin (T/I) over the above upper limit of normal, or positivity for serum troponin T by a rapid, qualitative assay 3. Clinical history or pathological findings of acute myocardial infarction. 2) Patients who have at least one coronary plaque involving 25% or more of the stenosis (at the culprit lesion, the plaque needs to be 10 mm or more away from the PCI lesion) 3) Patients with hypercholesterolemia as defined by either of the criteria below 1.LDL-C>=140mg/dL 2.LDL-C>=100mg/dL and patients who are judged by the investigator as needing cholesterol-lowering treatment by the investigator 4) Patients 20 years old or older at the time of provision of consent 5) Patients providing written consent for participation in this clinical trial on their own volition after receiving a thorough explanation about the study
Exclusion criteria
Exclusion criteria: 1) Target PCI lesion is graft stenosis or in-stent restenosis 2) Patients who had undergone previous PCI for the lesion under evaluation. 3) Patients who have plaque in a non-culprit site on the PCI vessel that might call for PCI during the treatment period (non-culprit lesion is unrestricted) 4) Patients already receiving lipid lowering agents (HMG-CoA reductase inhibitors [statins], fibrates, probucol, nicotinic acid, anion exchange resins, or ezetimib) 5) Patients with familial hypercholesterolemia 6) Patients with cardiogenic shock 7) Patients on cyclosporine therapy 8) Patients with a history of hypersensitivity to any of the components of the product 9) Patients with liver dysfunction (ALT[GPT] >= 100IU), biliary obstruction and/or defective hepatic metabolism: acute hepatitis, acute exacerbation of chronic hepatitis, liver cirrhosis, hepatic carcinoma and/or icterus 10) Pregnant and possibly pregnant women, lactating women 11) Patients with renal dysfunction (serum creatinine >=2.0 mg/dL) or on maintenance dialysis 12) Patients who are judged by the principal or other investigator to be ineligible for enrollment in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change in coronary fibrous-cap thickness | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Change in coronary fibrous-cap thickness 2) Absolute and percent change of the lipid core size 3) Absolute and percent changes of the serum LDL-C, TC, TG and HDL-C 4) Absolute and percent changes of the serum hs-CRP, MMP-9 and oxLDL 5) Correlation between percent changes of the serum lipid parameters and absolute/percent change of the coronary fibrous-cap thickness 6) Correlation between percent changes of the serum hs-CRP, MMP-9 and oxLDL and absolute/percent change of the coronary fibrous-cap thickness 7) Incidence of major adverse cardiovascular events (MACE; defined as cardiac death, Q-wave or non-Q-wave MI, PCI, or coronary artery bypass grafting) 8) All-cause mortality 9) Rate of adverse reactions 10) Changes of the laboratory test results | — |
Countries
Japan
Contacts
Public ContactTsuyoshi Nishiguchi
Wakayama Medical University Department of Cardiovascular Medicine
Outcome results
None listed