A Phase 4 interventional study of Everolimus Eluting Stent or Zotalolimus Eluting Stent and ARB, CCB, ACE-inhibitor, statin, Nitrate, Antiplate etc. in Coronary Artery Disease, sponsored by Yonsei University. Status unknown at 1 site in Korea, Republic of. Open to participants aged 75 Years to 84 Years. Per ClinicalTrials.gov, last updated 2012-01-12.
Sponsored by Yonsei University · Phase 4, Interventional, and Treatment
The primary purpose of this study is to determine whether PCI added to OMT could be superior over OMT alone in the prevention of late adverse cardiac and cerebro-vascular events in elderly patients with coronary artery disease (CAD) during the additional 12 months.
Study Design
Subsequently, subjects in PCI added to OMT group will be randomly assigned to everolimus eluting stent(n=400) vs. zotarolimus eluting sten(n=400). All subjects will be followed for 1 year after randomization. Additional long-term follow-up (2- or 3-year) will be preceded in the next plan after 1-year study period.
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's planned enrollment of 1,600 is above the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Yonsei University is the lead sponsor of 1,387 studies on the registry; 232 are open to participants now.
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Exclusion Criteria:
PCI (Everolimus Eluting Stent or Zotalolimus Eluting Stent) added to OMT after randomization and follow up for 12 months
Device: Everolimus Eluting Stent or Zotalolimus Eluting Stent
OMT alone after randomization and follow up for 12 months
Drug: ARB, CCB, ACE-inhibitor, statin, Nitrate, Antiplate etc.
Everolimus Eluting Stent(Xience V, Xience prime) Zotalolimus Eluting Stent(Endeavor-resolute, Resolute Integrity)
one or two anti-platelet agents, beta-blockers, calcium channel blockers, nitrates, angiotensin converting enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs), and statin
Major Adverse Cardiac Event
The primary end-point is the occurrence of major adverse cardiac event \[cardiovascular death, non-fatal MI (excluding periprocedural MI), stroke or any revascularization (PCI or coronary bypass surgery \[CABG\]) for 12 months following the randomization to the assigned management\]
Time frame: 12month
cardiac or non-cardiac major adverse event
1. The composite of cardiac or non-cardiac death, non-fatal MI, stent thrombosis (ST), target vessel revascularization (TVR) (either by PCI or CABG), non-TVR, hospitalization for unstable angina pectoris (UAP) or congestive heart failure (CHF), and cerebrovascular accident (CVA) for 12 months. 2. Major determinant for the occurrence of major events 3. Sub-study according to the subsets of disease 4. Association between parameters at index procedure and clinical outcomes
Time frame: 12month
This study is status unknown, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.
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Yonsei University