NCT02545231

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,000 (actual)
• Sponsor: Korea University Anam Hospital · Academic / Other
• Sex: All
• Age: 30 Years – 79 Years
• Healthy volunteers: Not accepted

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

Conditions

• Atherosclerosis
• Neointima
• Angina

Interventions

Type	Name	Description
DRUG	Pitavastatin 1mg	To compare different doses of statins on atherosclerosis progression and neointimal hyperplasia
DRUG	Pitavastatin 4mg	To compare different doses of statins on atherosclerosis progression and neointimal hyperplasia
DRUG	Placebo	To compare different doses of statins on atherosclerosis progression and neointimal hyperplasia

Timeline

• Start date: 2013-02-01
• Primary completion: 2018-12-01
• Completion: 2020-08-01
• First posted: 2015-09-09
• Last updated: 2020-11-10

Locations

1 site across 1 country: South Korea