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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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 Im

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 Summary:

  • 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

Sponsor: Korea University Anam Hospital

Current Primary Outcome: 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 [ Time Frame: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome: Rates of major adverse cardiovascular events during 12 months follow-up [ Time Frame: 12 months for clinical events ]

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


Original Secondary Outcome: Same as current

Information By: Korea University Anam Hospital

Dates:
Date Received: September 2, 2015
Date Started: February 2013
Date Completion: August 2017
Last Updated: December 23, 2016
Last Verified: December 2016