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

Atherosclerosis Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02545231
Study type Interventional
Source Korea University Anam Hospital
Contact
Status Completed
Phase Phase 4
Start date February 2013
Completion date August 2020
View Details
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