Health TrialsbyHealthPanel

OCT-Guided Stent Optimization for Short-Duration Dual Antiplatelet Therapy in Stable Angina

ConditionsStable AnginaCoronary Artery Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorKorea University Guro Hospital

About this trial

This study aims to evaluate whether the use of optical coherence tomography (OCT), an advanced intravascular imaging tool, can improve stent implantation results and make it possible to shorten the duration of dual antiplatelet therapy (DAPT) in patients with stable angina who undergo percutaneous coronary intervention (PCI).

PCI with drug-eluting stents is a standard treatment for patients with stable angina, and these patients are usually prescribed DAPT for 6 to 12 months to prevent stent thrombosis and other complications. However, extended use of DAPT increases the risk of bleeding, which can lead to significant medical problems, especially in patients with high bleeding risk.

OCT provides detailed, high-resolution images of the coronary arteries and the implanted stents, allowing physicians to optimize stent expansion and positioning. By ensuring that the stent is well-placed and fully expanded, OCT guidance may lower the risk of complications, potentially reducing the need for prolonged DAPT.

In this prospective study, patients with stable angina who require stent implantation will be enrolled and treated with OCT-guided PCI followed by a short course of DAPT. Their outcomes will be compared with those managed using conventional strategies.

The primary goal of this trial is to determine whether OCT-guided stent optimization can safely support a short-duration DAPT strategy, thereby reducing bleeding risk without compromising protection against ischemic events such as restenosis, myocardial infarction, or stent thrombosis.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients who undergo PCI using a cobalt-chromium everolimus-eluting stent (CoCr-EES)

Diagnosis of stable angina

Ability and willingness to provide written informed consent approved by the Institutional Review Board (IRB), and to comply with the study protocol and clinical follow-up schedule

Age ≥ 19 years

Disqualifiers

Patients diagnosed with acute coronary syndrome (ACS), including unstable angina or acute myocardial infarction

Contraindications to antiplatelet therapy or OCT imaging

Presence of lesions with severe stenosis, heavy calcification, or marked vessel tortuosity that prevent passage of a guidewire or catheter

Patients with previously implanted coronary stents in the target lesion

Trial design

Design model

Parallel

Treatments tested in this trial

  • Short DAPT

    Drug

    Patients receive aspirin and clopidogrel for 1 month after PCI. After 1 month, aspirin is discontinued and clopidogrel monotherapy is continued.

  • Standard DAPT

    Drug

    Patients with high bleeding risk will receive aspirin and clopidogrel for 6 months after PCI (unoptimization confirmed in OCT), followed by single antiplatelet therapy thereafter.

  • Extended DAPT

    Drug

    Patients (with stet unoptimazation results in OCT imaging) receive aspirin and clopidogrel for 12 months after PCI.

  • OCT-guided PCI

    Device

    All patients undergo percutaneous coronary intervention with mandatory intravascular imaging using optical coherence tomography to assess stent optimization (expansion, apposition, dissection).

Treatment groups

130 Participants
are divided into 3 treatment groups
Group A: Short DAPTExperimental treatment 2 interventions
Group B: Standard DAPTActive comparator 2 interventions
Group C: Extended DAPTActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Net Adverse Cardiovascular Events (NACE)

Composite of cardiac death, non-fatal myocardial infarction, definite/probable stent thrombosis (ARC definition), stroke, repeat coronary revascularization, or clinically significant bleeding defined as BARC types 2, 3, or 5. Analyses will use time-to-first-event; each component will also be summarized separately as secondary outcomes per protocol.

Time frame
12 months after the index PCI

Secondary outcomes

1

Major Adverse Cardiovascular Events (MACE)

Composite of cardiac death, non-fatal myocardial infarction, definite/probable stent thrombosis (ARC), repeat coronary revascularization, or stroke (time-to-first-event).

Time frame
12 months after PCI
2

All bleeding events

Any bleeding by BARC criteria (types 1-5).

Time frame
12 months after the index PCI
3

All-cause death

Death from any cause.

Time frame
12 months after the index PCI
4

Cardiac death

Death due to cardiac causes (e.g., MI, sudden cardiac death, heart failure), per protocol definition.

Time frame
12 months after the index PCI

Other outcomes

Sponsors and contacts

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

Korea University Guro Hospital

Lead sponsor

Abbott

Collaborator

Source ClinicalTrials.gov
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