Objectives: To assess the safety of tailored antiplatelet therapy (short DAPT followed by P2Y12 inhibitor alone strategy) in patients who received optimized DES implantation guided by intravascular imaging (IVUS or OCT) Hypothesis: Tailored antiplatelet strategy (short DAPT followed by P2Y12 inhibitor alone) is superior to conventional antiplatelet strategy in terms of clinically relevant bleeding and noninferior for ischemic composite adverse events in patients who received intravascular imaging-guided optimized DES implantation. (Optimized stent evaluated by on-site IVUS/OCT could act as an essential criterion for decision making for tailored antithrombotic strategy)
Objective: To assess the safety of tailored antiplatelet strategy (short DAPT followed by P2Y12 inhibitor alone) in patients who received optimized DES implantation guided by intravascular imaging (IVUS or OCT) Design: Prospective, open label, multi-center, dual arm, randomized trial Number of Subjects 3,944 subjects (1972:1972) Study Population: Patients with coronary artery disease undergoing imaging-guided PCI Study Design: * Eligible subjects will be randomized 1:1 to a) conventional DAPT strategy or b) tailored anti-platelet strategy (short DAPT followed by P2Y12 inhibitor alone) after optimized DES implantation guided by intravascular imaging. * All subjects will be clinically followed at 1(or 3), 6, and 12, 18, 24, 36, 48, 50 months Co-primary Endpoints: 1. Ischemic composite of all-cause death, myocardial infarction, ischemia-driven target-vessel revascularization, and definite or probable stent thrombosis at 12 months post-PCI 2. Net adverse clinical events, defined as the ischemic composite plus clinically relevant bleeding at 12 months post-PCI 3. Clinically relevant bleeding, defined as Bleeding Academic Research Consortium type 2, 3, or 5 bleeding at 12 months post-PCI Statistics and Analysis: The study was designed to test the hypothesis that tailored antithrombotic strategy, as compared to the conventional DAPT, would be superior for clinically relevant bleeding, noninferior to the ischemic composite adverse events and NACE. The primary analysis would be evaluated by intention-to-treat analysis. With 3756 (each 1,878) patients, this study has \>80% power to detect noninferiority of tailored antiplatelet strategy for ischemic composite adverse event, \>85% power to detect noninferiority of tailored antiplatelet strategy for NACE, and \>85% power to detect superiority of the tailored antiplatelet arm on clinically relevant bleeding. To compensate for 5% attrition rate, 3,944 (each 1,972) patients will be randomized.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
3,944
DAPT strategy
Bucheon Sejong Hospital
Bucheon-si, South Korea
RECRUITINGDong-A University Hospital
Busan, South Korea
RECRUITINGInje University Busan Paik Hospital
Busan, South Korea
NOT_YET_RECRUITINGInje University Haeundae Paik Hospital
Busan, South Korea
Composite ischemic endpoint
Ischemic composite adverse event of all-cause death, myocardial infarction (MI), ischemia-driven target vessel revascularization (TVR), definite/probable stent thrombosis (ST)
Time frame: 12 month
Net adverse clinical events (NACE)
Net clinical outcome defined as a composite of all-cause death, myocardial infarction (MI), ischemia-driven target vessel revascularization (TVR), definite/probable stent thrombosis (ST), and clinically relevant bleeding \[BARC 2, 3, or 5\]
Time frame: 12 month
Clinically relevant bleeding
Clinically relevant bleeding \[Bleeding Academic Research Consortium (BARC) 2, 3, or 5\]
Time frame: 12 month
Individual components of the composite ischemic endpoint
Individual components of the composite ischemic endpoints including 1) all-cause death; 2) myocardial infarction (MI); 3) ischemia-driven target-vessel revascularization (TVR); and 4) definite or probable stent thrombosis (ST)
Time frame: 12 month
Cardiovascular death
Sudden cardiac death; death due to acute myocardial infarction (MI), heart failure, cardiogenic shock, stroke, other cardiovascular causes, or fatal bleeding
Time frame: 12 month
Stroke
An acute focal neurologic deficit of presumed vascular origin lasting ≥ 24 h or resulting in death and classified as ischemic or hemorrhagic
Time frame: 12 month
Individual BARC bleeding categories
Type 0 (No bleeding); Type 1 (Minor, Non-Actionable Bleeding); Type 2 (Actionable Bleeding); Type 3 (Major Bleeding); Type 4 (CABG-Related Bleeding); Type 5 (Fatal Bleeding)
Time frame: 12 month
Stent strut coverage in the OCT substudy
% difference of strut coverage on FU OCT between optimal vs. suboptimal DES implantation group
Time frame: 1 or 3 month
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Kosin University Gospel Hospital
Busan, South Korea
RECRUITINGGyeongsang National University Changwon Hospital
Changwon, South Korea
RECRUITINGKangwon National University Hospital
Chuncheon, South Korea
RECRUITINGChungbuk National University Hospital
Chungju, South Korea
RECRUITINGDaegu Catholic Univ Medical Center
Daegu, South Korea
NOT_YET_RECRUITINGKeimyung University Dongsan Medical Center
Daegu, South Korea
RECRUITING...and 23 more locations