To asses the efficacy of two different regimens of intensive LDL-cholesterol lowering therapy with statin or statin and ezetimibe on the plaque volume and plaque morphology in patients with acute coronary syndrome during 6 months.
Conditions
Interventions
In high dose statin group, patients will be administered 4mg of pitavastatin once daily during 6 monts follow-up.
In low dose statin group, patients will be administered 1mg of pitavastatin and 10mg o
Sponsors
Juntendo University School of Medicine
Juntendo University Shizuoka hospital (registration of case) Juntendo University hospital (IVUS anlysis)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients are eligible for inclusion if they have ACS with significant stenosis on initial coronary angiography and recieved PCI. ACS is define as high-risk unstable angina, non-ST elevated myocardial infarction (NSTEMI) or ST-elevated MI (STEMI). MI will be diagnosed by patient symptoms, ECG changes (ST segment changes or a new bundle branch block) and highly sensitive biochemical markers (the rise in serum creatine phosphokinase-MB and positivity for troponin T or human heart fatty acid binding protein (H-FABP)), as well as information gleaned from various imaging techniques
Exclusion criteria
Exclusion criteria: A case of failed PCI diseased bypass graft recommended CABG cardiogenic shock A case of administration of other lipid-lowering drugs (clofibrate, probucol, nicotinic acid, or other prohibited drug without ezetimibe).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percent change in plaque and vessel volume in non-culprit lesion on IVUS analysis during 6 months after onset of ACS. | — |
Secondary
| Measure | Time frame |
|---|---|
| Correlation between the percent change in plaque volume and the biomarkers including LDL-cholesterol level. Major adverse cardiovascular event | — |
Countries
Japan
Contacts
Public ContactShinya Okazaki
Juntendo University Nerima hospital Cardiology
Outcome results
None listed