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 ]
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 ]
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