Clinical trial NCT02545231: Effect of Low-dose vs. High-dose Pitavastatin on In-stent Restenosis
Official title: Effect of Low-dose vs. High-dose Pitavastatin on In-stent Restenosis, Endothelial Function, Circulating microRNAs, and Cardiovascular Events in Patients With Coronary Artery Disease Requiring Stent Implantation: OCT and NIRS Comparison
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atherosclerosis
Neointima
Angina
Lead sponsor: Korea University Anam Hospital
Sponsor class: OTHER
First posted: 2015-09-09
Enrollment: 1000
Sex: ALL
Minimum age (years): 30
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 12 months for OCT and NIRS
Secondary outcomes:
measure: Rates of major adverse cardiovascular events during 12 months follow-up
timeFrame: 12 months for clinical events
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
Study officials:
affiliation: Korea University Hospital
name: Do-Sun Lim, MD, PhD
role: STUDY_CHAIR
References:
citation: Jeong HS, Hong SJ, Son S, An H, Kook H, Joo HJ, Park JH, Yu CW, Lim DS. Incidence of new-onset diabetes with 1 mg versus 4 mg pitavastatin in patients at high risk of developing diabetes during a 3-year follow-up. Cardiovasc Diabetol. 2019 Nov 21;18(1):162. doi: 10.1186/s12933-019-0969-z.
citation: Lim JW, Jeong HS, Hong SJ, Kim HJ, Kim YC, Kang BG, Jeon SM, Cho JY, Lee SH, Joo HJ, Park JH, Yu CW. Effects of lowest-dose vs. highest-dose pitavastatin on coronary neointimal hyperplasia at 12-month follow-up in type 2 diabetic patients with non-ST elevation acute coronary syndrome: an optical coherence tomography analysis. Heart Vessels. 2019 Jan;34(1):62-73. doi: 10.1007/s00380-018-1227-0. Epub 2018 Jul 25.