Effect of Low-dose vs. High-dose Pitavastatin on In-stent Restenosis

Korea University Anam Hospital1,000 enrolled

Overview

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.

* 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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

1,000

Conditions

Atherosclerosis Neointima Angina

Interventions

Pitavastatin 1mgDRUG

To compare different doses of statins on atherosclerosis progression and neointimal hyperplasia

Pitavastatin 4mgDRUG

To compare different doses of statins on atherosclerosis progression and neointimal hyperplasia

PlaceboDRUG

To compare different doses of statins on atherosclerosis progression and neointimal hyperplasia

Eligibility

Sex: ALLMin age: 30 YearsMax age: 79 Years

Medical Language ↔ Plain English

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

Locations (1)

Korea University Anam Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

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

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.

Time frame: 12 months for OCT and NIRS

Secondary Outcomes

Rates of major adverse cardiovascular events during 12 months follow-up

Major adverse cardiovascular events include all-cause death, cardiovascular death, myocardial infarction, stroke, target vessel revascularization

Time frame: 12 months for clinical events

Data from ClinicalTrials.gov

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