Atherosclerosis Clinical Trial
— ELEVATEOfficial 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
Verified date | November 2020 |
Source | Korea University Anam Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 1000 |
Est. completion date | August 2020 |
Est. primary completion date | December 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 30 Years to 79 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Korea University Anam Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Korea University Anam Hospital |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 12 months for OCT and NIRS | |
Secondary | 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 | 12 months for clinical events |
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