About this trial
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)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Men or women ≥19 years
Typical chest pain or objective evidence of myocardial ischemia suitable for PCI
Significant de novo coronary artery lesions suitable for DES implantation
Patients who underwent optimized stent implantation either by IVUS or OCT
Disqualifiers
Extreme angulation (≥90°) proximal to or within the target lesion.
Excessive tortuosity (≥ two 45° angles) proximal to or within the target lesion.
Heavy calcification proximal to or within the target lesion.
In-stent restenosis
Trial design
Parallel
Treatments tested in this trial
aspirin
DrugDAPT strategy
Treatment groups
Trial outcomes
Primary outcomes
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)
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 \[BARC 2, 3, or 5\]
Clinically relevant bleeding
Clinically relevant bleeding \[Bleeding Academic Research Consortium (BARC) 2, 3, or 5\]
Secondary outcomes
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)
Cardiovascular death
Sudden cardiac death; death due to acute myocardial infarction (MI), heart failure, cardiogenic shock, stroke, other cardiovascular causes, or fatal bleeding
Stroke
An acute focal neurologic deficit of presumed vascular origin lasting ≥ 24 h or resulting in death and classified as ischemic or hemorrhagic
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)
Sponsors and contacts
Click on the lead sponsor to view all of their trials.