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, 6, and 12 months Co-primary Endpoints: 1. Clinically relevant bleeding (BARC 2, 3, or 5) at 12 months post-PCI 2. Ischemic composite adverse events of all-cause death, MI, ischemia-driven TVR, stent thrombosis at 12 months post-PCI 3. Net clinical outcome (NACE) of all-cause death, MI, ischemia-driven TVR, stent thrombosis, BARC 2,3,5 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_RECRUITINGKosin 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
RECRUITINGKyungpook National University Hospital
Daegu, South Korea
NOT_YET_RECRUITING...and 15 more locations
1) clinically relevant bleeding [Bleeding Academic Research Consortium (BARC) 2, 3, or 5]
1\) clinically relevant bleeding \[Bleeding Academic Research Consortium (BARC) 2, 3, or 5\]
Time frame: 12 month
2) net clinical outcome defined as a composite of all-cause death, MI, ischemia-driven target vessel revascularization (TVR), definite/probable stent thrombosis (ST), and clinically relevant bleeding [BARC 2, 3, or 5]
2\) net clinical outcome defined as a composite of all-cause death, 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
3) ischemic composite adverse event of all-cause death, MI, ischemia-driven target vessel revascularization (TVR), definite/probable stent thrombosis (ST)
3\) ischemic composite adverse event of all-cause death, MI, ischemia-driven target vessel revascularization (TVR), definite/probable stent thrombosis (ST)
Time frame: 12 month
1) Major or minor bleeding according to definitions from TIMI and International Society of Thrombosis or Hemostasis (ISTH)
1\) Major or minor bleeding according to definitions from TIMI and International Society of Thrombosis or Hemostasis (ISTH)
Time frame: 12 month
2) % difference of strut coverage on FU OCT between optimal vs. suboptimal DES implantation group
2\) % difference of strut coverage on FU OCT between optimal vs. suboptimal DES implantation group
Time frame: 1 or 3 month
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