NCT02316886

Preventive PCI or Medical Therapy Alone for Vulnerable Atherosclerotic Coronary Plaque

a Multinational, Multicenter, Prospective, Open-label, Active-treatment-controlled Randomized Trial: Preventive PCI or Medical Therapy Alone for Vulnerable Atherosclerotic Coronary Plaque_PREVENT Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,608 (actual)
• Sponsor: Seung-Jung Park · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary aim of the trial is to determine whether preventive PCI with bioabsorbable vascular scaffolds (BVS) (early period) or everolimus-eluting stents (middle and late period) plus optimal medical therapy (OMT) on functionally insignificant (FFR \> 0.80) vulnerable coronary plaque, as determined by intracoronary imaging, would result in a significant reduction of the primary composite outcome of death from cardiac causes, target-vessel myocardial infarction (MI), target-vessel revascularization (TVR), and hospitalization for unstable or progressive angina at 2 years, when compared with OMT alone.

Detailed description

Sub-analysis for each imaging test will be performed as below; * NIRS(Near-infrared spectroscopy) * OCT(Optical coherence tomography) * VH-IVUS(IVUS-derived virtual histology) * IVUS(Intravascular ultrasonography) Extended follow-up: Considering the nature of functionally insignificant coronary stenosis with vulnerable plaque, most subjects are watched for extended follow-up after the planned 2-year follow-up time point.

Conditions

• Coronary Artery Disease
• Plaque, Atherosclerotic

Interventions

Type	Name	Description
DEVICE	Coronary intervention	bioabsorbable vascular scaffolds (BVS) (early period) or everolimus-eluting stents (middle and late period) + Optimal Medical Treatment
DRUG	Optimal Medical treatment

Timeline

• Start date: 2015-10-05
• Primary completion: 2023-10-19
• Completion: 2023-10-19
• First posted: 2014-12-15
• Last updated: 2023-11-18

Locations

18 sites across 5 countries: United States, Japan, New Zealand, South Korea, Taiwan