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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PCI+OMT group | Experimental | PCI (Everolimus Eluting Stent or Zotalolimus Eluting Stent) added to OMT after randomization and follow up for 12 months |
|
| OMT alone group | Active Comparator | OMT alone after randomization and follow up for 12 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Everolimus Eluting Stent or Zotalolimus Eluting Stent | Device | Everolimus Eluting Stent(Xience V, Xience prime) Zotalolimus Eluting Stent(Endeavor-resolute, Resolute Integrity) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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] | 12month |
| Measure | Description | Time Frame |
|---|---|---|
| cardiac or non-cardiac major adverse event |
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Myeong-Ki Hong, MD.PhD | Contact | +82 2 2228 8458 | mkhong61@yuhs.ac |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Myeong-Ki, Hong | Recruiting | Seoul | South Korea |
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| ARB, CCB, ACE-inhibitor, statin, Nitrate, Antiplate etc. | Drug | one or two anti-platelet agents, beta-blockers, calcium channel blockers, nitrates, angiotensin converting enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs), and statin |
|
| 12month |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D002121 | Calcium Channel Blockers |
| D000806 | Angiotensin-Converting Enzyme Inhibitors |
| D019161 | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
| D009566 | Nitrates |
| ID | Term |
|---|---|
| D049990 | Membrane Transport Modulators |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000077264 | Calcium-Regulating Hormones and Agents |
| D045505 | Physiological Effects of Drugs |
| D002317 | Cardiovascular Agents |
| D045506 | Therapeutic Uses |
| D011480 | Protease Inhibitors |
| D004791 | Enzyme Inhibitors |
| D000924 | Anticholesteremic Agents |
| D000960 | Hypolipidemic Agents |
| D000963 | Antimetabolites |
| D057847 | Lipid Regulating Agents |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D007287 | Inorganic Chemicals |
| D017942 | Nitric Acid |
| D017672 | Nitrogen Compounds |
| D009930 | Organic Chemicals |
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