Comparison of the Efficacy and Safety of New Platform Everolimus-eluting Coronary Stent System (Promus Element) With Zotarolimus-eluting Coronary Stent System (Endeavor Resolute) and Triple Anti-platelet Therapy With Double-dose Clopidogrel Anti-platelet Therapy in Patients With Coronary Heart Disease
试验速览
- 阶段
- 4 期
- 入组人数
- 3,750
- 试验地点
- 1
- 主要终点
- Target lesion failure (TLF)
研究概览
简要总结
Objectives
- To compare the safety and long-term effectiveness of coronary stenting with the new platform Everolimus-Eluting coronary stenting system (EECSS, Promus Element) compared with the Zotarolimus-Eluting coronary stenting system (ZECSS, Endeavor Resolute) in patients with coronary heart disease (CHD)
- To determine the short-term efficacy and safety of triple anti-platelet therapy (TAT, Aspirin 100mg qd, Clopidogrel 75mg qd and Cilostazol 100mg bid) compared with double-dose clopidogrel dual anti-platelet therapy (DDAT, Aspirin 100mg qd and Clopidogrel 150mg qd) in patients undergoing percutaneous coronary intervention (PCI) with drug-eluting stents (DES)
Study design Prospective, open-label, 2-by-2 multifactorial, randomized, multicenter trial to test the following in CHD patients
- Non-inferiority of Promus Element stent compared with Endeavor Resolute stent in reducing target lesion failure (TLF)
- Non-inferiority of TAT compared with DDAT in reducing net clinical outcome Patients will be randomized in a 2-by-2 factorial manner according to the type of drug eluting stent (EECSS vs. ZECSS) and the type anti-platelet regimen (TAT vs. DDAT). Randomization will also be stratified per presence of DM.
Patient enrollment 3750 patients enrolled at 50 centers in Republic of Korea
Patient follow-up Clinical follow-up will occur at 1, 3, 12, 24, 36 months after the procedure. Angiographical follow-up will be recommended to all participants at 13 months after the procedure. Investigator or designee may conduct follow-up as telephone contacts or office visits.
Primary endpoint
- Target lesion failure (TLF), defined as a composite of cardiac death, target vessel-related myocardial infarction (MI) and ischemia-driven target lesion revascularization (TLR) up to 12 months for the stent arm
- Net clinical outcome, defined as a composite of cardiac death, nonfatal MI, CVA and major bleeding by PLATO criteria at 1 month for the anti-platelet arm
详细描述
Secondary endpoint
- Clinical and laboratory endpoint at 1 month All death and cardiac death Myocardial infarction (q wave and non-q wave) Stent thrombosis (definite and possible) CVA (hemorrhagic and non-hemorrhagic) Bleeding (major and minor) VerifyNow ASA and VerifyNow P2Y12
- Clinical endpoint at 12 months All death and cardiac death Target vessel-related MI and all MI (q wave and non-q wave) Target vessel/lesion revascularization (ischemia-driven and all) Stent thrombosis (definite/possible/probable) Net clinical outcome including bleeding (major and minor) Acute success of procedure (device, lesion and procedure)
- Angiographic (including IVUS or OCT) endpoint at 13 months In-stent & In-segment late loss In-stent & In-segment % diameter stenosis Angiographic pattern of restenosis Neointimal volume, % neointimal volume and % volume obstruction on IVUS or OCT Degree of stent strut endothelialization on OCT
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
EECSS + DDAT
Promus Element stent + double-dose clopidogrel anti-platelet therapy
干预措施: Everolimus-eluting coronary stenting system (EECSS, Promus Element) (Device)
EECSS + DDAT
Promus Element stent + double-dose clopidogrel anti-platelet therapy
干预措施: Double-dose clopidogrel anti-platelet therapy (DDAT) (Drug)
ZECSS + DDAT
Endeavor Resolute stent + double-dose clopidogrel anti-platelet therapy
干预措施: Zotarolimus-eluting coronary stenting system (ZECSS, Endeavor Resolute) (Device)
ZECSS + DDAT
Endeavor Resolute stent + double-dose clopidogrel anti-platelet therapy
干预措施: Double-dose clopidogrel anti-platelet therapy (DDAT) (Drug)
EECSS + TAT
Promus Element stent + triple anti-platelet therapy
干预措施: Everolimus-eluting coronary stenting system (EECSS, Promus Element) (Device)
EECSS + TAT
Promus Element stent + triple anti-platelet therapy
干预措施: Triple anti-platelet therapy (TAT) (Drug)
ZECSS + TAT
Endeavor Resolute stent + triple anti-platele therapy
干预措施: Zotarolimus-eluting coronary stenting system (ZECSS, Endeavor Resolute) (Device)
ZECSS + TAT
Endeavor Resolute stent + triple anti-platele therapy
干预措施: Triple anti-platelet therapy (TAT) (Drug)
结局指标
主要结局
Target lesion failure (TLF)
时间窗: 12 months
Composite of cardiac death, target vessel-related myocardial infarction (MI) and ischemia-driven target lesion revascularization (TLR)
Net clinical outcome
时间窗: 1 month
Composite of cardiac death, nonfatal MI, CVA and major bleeding by PLATO criteria
次要结局
未报告次要终点