Coronary Heart Disease Clinical Trial
Official title:
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
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
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
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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