Harmonizing Optimal Strategy for Treatment of Coronary Artery Stenosis - SAfety & EffectiveneSS of Drug-ElUting Stents & Anti-platelet REgimen
- Conditions
- Coronary Heart Disease
- Interventions
- Device: Everolimus-eluting coronary stenting system (EECSS, Promus Element)Device: Zotarolimus-eluting coronary stenting system (ZECSS, Endeavor Resolute)Drug: Triple anti-platelet therapy (TAT)
- Registration Number
- NCT01267734
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
Objectives
1. 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)
2. 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
1. Non-inferiority of Promus Element stent compared with Endeavor Resolute stent in reducing target lesion failure (TLF)
2. 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
1. 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
2. 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
- Detailed Description
Secondary endpoint
1. 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
2. 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)
3. 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 3750
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description EECSS + DDAT Everolimus-eluting coronary stenting system (EECSS, Promus Element) Promus Element stent + double-dose clopidogrel anti-platelet therapy ZECSS + DDAT Zotarolimus-eluting coronary stenting system (ZECSS, Endeavor Resolute) Endeavor Resolute stent + double-dose clopidogrel anti-platelet therapy EECSS + TAT Everolimus-eluting coronary stenting system (EECSS, Promus Element) Promus Element stent + triple anti-platelet therapy EECSS + TAT Triple anti-platelet therapy (TAT) Promus Element stent + triple anti-platelet therapy ZECSS + TAT Zotarolimus-eluting coronary stenting system (ZECSS, Endeavor Resolute) Endeavor Resolute stent + triple anti-platele therapy ZECSS + TAT Triple anti-platelet therapy (TAT) Endeavor Resolute stent + triple anti-platele therapy EECSS + DDAT Double-dose clopidogrel anti-platelet therapy (DDAT) Promus Element stent + double-dose clopidogrel anti-platelet therapy ZECSS + DDAT Double-dose clopidogrel anti-platelet therapy (DDAT) Endeavor Resolute stent + double-dose clopidogrel anti-platelet therapy
- Primary Outcome Measures
Name Time Method Target lesion failure (TLF) 12 months Composite of cardiac death, target vessel-related myocardial infarction (MI) and ischemia-driven target lesion revascularization (TLR)
Net clinical outcome 1 month Composite of cardiac death, nonfatal MI, CVA and major bleeding by PLATO criteria
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of