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Tailored Versus Coventional AntiPlaTelet Strategy Intended After OPTIMIZEd Drug Eluting Stent

ConditionCoronary Artery Disease
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

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

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

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

Secondary outcomes

1

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

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

Other outcomes

Sponsors and contacts

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

Asan Medical Center

Lead sponsor

Source ClinicalTrials.gov
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