Atherosclerosis, Neointima, Angina
Conditions
Brief summary
To compare low dose (1mg) pitavastatin and high dose (4mg) pitavastatin on neointimal hyperplasia and atherosclerosis progression by using optical coherence tomography (OCT) and near-infrared spectroscopy (NIRS) at 12 months follow-up and on clinical adverse cardiovascular events during 3-year follow-up.
Detailed description
* Patients with non-ST elevation ACS will be randomized into pitavastatin 1mg or 4mg after everolimus-eluting stent implantation with OCT and NIRS study. * 12 months follow-up coronary angiography with OCT and NIRS will be performed to compare neointimal hyperplasia and atherosclerosis progression. * 36 months clinical follow-up for major adverse cardiovascular events (cardiac death, all-cause death, myocardial infarction, stroke, target lesion revascularization) will be compared. * Safety issues such as bleeding rates, abnormal liver function will be compared
Interventions
DRUGPlacebo
To compare different doses of statins on atherosclerosis progression and neointimal hyperplasia
DRUGPitavastatin 1mg
To compare different doses of statins on atherosclerosis progression and neointimal hyperplasia
DRUGPitavastatin 4mg
To compare different doses of statins on atherosclerosis progression and neointimal hyperplasia
Sponsors
Korea University Anam Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
1. Provision of informed consent prior to any study specific procedures 2. Patients between the age of 30 to 79 3. Non-ST elevation Acute coronary syndrome with successful everolimus eluting stent implantation (with TIMI flow grade 3 after the procedure)
Exclusion criteria
1. Hypersensitivity to pitavastatin 2. Unable to perform OCT and NIRS 3. Serum creatinine \> 2.0 mg/dL. 4. Steroid or hormone replacement therapy 5. Hemoglobin A1c \>9% 6. Type 1 diabetes 7. Decreased serum platelet level (\< 100,000/uL) 8. Need for chronic oral anticoagulant therapy or chronic low-molecular-weight heparin 9. Life expectancy less than a year 10. Renal failure requiring dialysis or anticipated need for dialysis during the course of the study 11. Any condition which in the opinion of the investigator would make it unsafe or unsuitable for the patient to participate in this study 12. Involvement in the planning and/or conduct of the study 13. Left ventricular ejection fraction \< 40% 14. Hepatic dysfunction (aspartate aminotransferase or alanine aminotransferase \> twice the upper limit) 15. Gastrointestinal disorder such as Crohn's disease 16. Alcohol abuse 17. Known pregnancy, breast-feeding, or intend to become pregnant during the study period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neointimal volume with OCT (mm3 per 1mm) and lipid volume with NIRS (the maximal lipid core burden index (LCBI) in 4 mm segment during 12 months of treatment | 12 months for OCT and NIRS | OCT will measure neointimal volume in every mm interval and will be averaged by dividing the total neointimal volume with the number of the segment analyzed. LCBI is the lipid volume index which is calculated automatically by the device, and LCBI \> 400 is considered high lipid volume. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rates of major adverse cardiovascular events during 12 months follow-up | 12 months for clinical events | Major adverse cardiovascular events include all-cause death, cardiovascular death, myocardial infarction, stroke, target vessel revascularization |
Countries
South Korea
Outcome results
None listed