OPTIMIZE-APT: Tailored Versus Conventional Antiplatelet Therapy After Intravascular Imaging-guided Drug-eluting Stent Implantation

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age19+
SponsorAsan Medical Center

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • aspirin

    Drug

    DAPT strategy

Treatment groups

3,944 Participants
are divided into 2 treatment groups
Group A: Conventional ArmActive comparator 1 intervention
Group B: Tailored ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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
3

Clinically relevant bleeding

Clinically relevant bleeding \[Bleeding Academic Research Consortium (BARC) 2, 3, or 5\]

Time frame
12 month

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.