Stable AnginaCOMFORT-SHORTNCT07198529
OCT-Guided Stent Optimization for Short-Duration Dual Antiplatelet Therapy in Stable Angina
A study testing Short DAPT, Standard DAPT and Extended DAPT in people with Stable Angina and Coronary Artery Disease, run by Korea University Guro Hospital at 1 site in South Korea.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Stable Angina, Coronary Artery Disease
- What is being tested?
- Short DAPT, Standard DAPT and Extended DAPT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Sep 2025to Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Cardiovascular Center, Department of Internal Medicine, Korea University Guro Hospital
Seoul, Gurodong-ro, Guro-gu, 148
About this study
Official title: Optical Coherence Tomography for Stent Optimization and Its Impact on Short-Duration Dual Antiplatelet Therapy: A Single-Center, Prospective, Exploratory Study
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.
Read more
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.
Read the detailed description
Ischemic heart disease (IHD) remains one of the leading causes of death worldwide, and more than 80% of deaths from coronary artery disease (CAD) occur in individuals aged 65 years or older. Elderly patients often have multiple comorbidities, such as diabetes mellitus, hypertension, and chronic kidney disease, which increase both ischemic and bleeding risks. For these patients, the management of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) is particularly challenging, as physicians must balance ischemic protection against the risk of bleeding complications.
Optical coherence tomography (OCT) provides high-resolution intravascular imaging that allows precise assessment of stent apposition, expansion, and the presence of dissections. Previous studies, including Kubo et al. (2022), have proposed OCT-based criteria for stent optimization, demonstrating that inadequate stent expansion or a minimum lumen area (MLA) < 4.5 mm² is associated with worse outcomes. However, to date, few clinical studies have directly evaluated whether OCT-guided stent optimization can support individualized adjustment of DAPT duration.
The COMFORT-SHORT study is a prospective, single-center, open-label pilot registry designed to investigate the safety and feasibility of OCT-guided stent optimization in applying short-term DAPT strategies. Patients with stable angina undergoing PCI with drug-eluting stent implantation will be enrolled. All participants will undergo OCT during PCI to evaluate stent deployment. Stent size and length will be determined based on OCT analysis, and final imaging will be reviewed to confirm whether the procedure meets predefined optimization criteria.
Patients whose stents are confirmed as optimized will be transitioned to 1 month of DAPT followed by clopidogrel monotherapy. Patients with suboptimal results (e.g., malapposition, medial dissection, under-expansion) will continue standard DAPT for 6-12 months, based on guideline recommendations and individual bleeding. Importantly, patients with non-optimized stents will not be excluded; they will be followed prospectively, and outcomes will be compared with those of optimized patients.
The primary endpoint is the incidence of net adverse clinical events (NACE) at 12 months, comparing short-term versus standard DAPT strategies according to stent optimization status. All enrolled patients will undergo scheduled follow-up at 1, 6, and 12 months after PCI.
- Conditions
- Stable Angina, Coronary Artery Disease
- Being tested
- Short DAPT, Standard DAPT, Extended DAPT, OCT-guided PCI
- Keywords
- Optical coherence tomography, stable angina, dual antiplatelet therapy, stent optimization, percutaneous coronary intervention
- Medical subject headings
- Angina, Stable, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short DAPTDrug
Patients receive aspirin and clopidogrel for 1 month after PCI. After 1 month, aspirin is discontinued and clopidogrel monotherapy is continued.
Standard DAPTDrug
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 DAPTDrug
Patients (with stet unoptimazation results in OCT imaging) receive aspirin and clopidogrel for 12 months after PCI.
OCT-guided PCIDevice
All patients undergo percutaneous coronary intervention with mandatory intravascular imaging using optical coherence tomography to assess stent optimization (expansion, apposition, dissection).
| Study group | Role | What they receive |
|---|---|---|
| Short DAPT | Experimental | Patients with optimized stent results confirmed by OCT will receive 1 month of dual antiplatelet therapy followed by clopidogrel monotherapy. Receives: Drug: Short DAPT; Device: OCT-guided PCI |
| Standard DAPT | Active comparator | Patients with suboptimal stent results (malapposition, dissection, under-expansion) with high bleeding risk will continue dual antiplatelet therapy for 6 months, according to guideline recommendations. Receives: Drug: Standard DAPT; Device: OCT-guided PCI |
| Extended DAPT | Active comparator | Patients with suboptimal stent results and high ischemic risk, as judged by the operator, will remain on dual antiplatelet therapy for 12 months. Receives: Drug: Extended DAPT; Device: OCT-guided PCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months after the index PCI
Secondary outcomes (8)
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).
Measured: 12 months after PCI
All bleeding events
Any bleeding by BARC criteria (types 1-5).
Measured: 12 months after the index PCI
All-cause death
Death from any cause.
Measured: 12 months after the index PCI
Cardiac death
Death due to cardiac causes (e.g., MI, sudden cardiac death, heart failure), per protocol definition.
Measured: 12 months after the index PCI
Myocardial infarction
MI defined per protocol-specified criteria (e.g., Fourth Universal Definition of MI); adjudicated events will be counted.
Measured: 12 months after the index PCI
Stent thrombosis
Definite or probable stent thrombosis per ARC definitions.
Measured: 12 months
Repeat revascularization
Any coronary revascularization (PCI or CABG), including TLR/TVR as defined in the protocol.
Measured: 12 months
Stroke
Ischemic or hemorrhagic stroke confirmed by clinical assessment and/or neuroimaging, with a new focal neurologic deficit lasting >24 hours or resulting in death.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2025
- Study start30 Sep 2025
- Primary completionSep 2029 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stable AnginaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective, single-center, open-label study with a parallel assignment design. All patients undergo OCT-guided PCI. Based on OCT findings, patients are categorized into two groups: those with optimized stent results receive short-duration DAPT (1 month), while those with suboptimal stent results continue standard DAPT (6-12 months) according to guidelines. Outcomes will be compared between groups.
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korea University Guro Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Principal investigator, Park, Soohyung, Korea University Guro Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07198529
- Sponsor's protocol ID
- No.2025GR0393
- Other IDs
- KOR-2023-02
- Acronym
- COMFORT-SHORT
- Status last verified
- Dec 2025
- First submitted
- 19 Sep 2025
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Data sharing may be considered after study completion and publication of the main results, depending on institutional policies and participant privacy considerations.
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Coherence Tomography for Stent Optimization and Its Impact on Short-Duration Dual Antiplatelet Therapy: A Single-Center, Prospective, Exploratory Study
- ClinicalTrials.gov ID
- NCT07198529
- Acronym / sponsor ID
- COMFORT-SHORT / No.2025GR0393
- Conditions
- Stable Angina, Coronary Artery Disease
- Keywords
- Optical coherence tomography, stable angina, dual antiplatelet therapy, stent optimization, percutaneous coronary intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Korea University Guro HospitalUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- 30 Sep 2025 (actual)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 30 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Ischemic heart disease (IHD) remains one of the leading causes of death worldwide, and more than 80% of deaths from coronary artery disease (CAD) occur in individuals aged 65 years or older. Elderly patients often have multiple comorbidities, such as diabetes mellitus, hypertension, and chronic kidney disease, which increase both ischemic and bleeding risks. For these patients, the management of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) is particularly challenging, as physicians must balance ischemic protection against the risk of bleeding complications.
Optical coherence tomography (OCT) provides high-resolution intravascular imaging that allows precise assessment of stent apposition, expansion, and the presence of dissections. Previous studies, including Kubo et al. (2022), have proposed OCT-based criteria for stent optimization, demonstrating that inadequate stent expansion or a minimum lumen area (MLA) < 4.5 mm² is associated with worse outcomes. However, to date, few clinical studies have directly evaluated whether OCT-guided stent optimization can support individualized adjustment of DAPT duration.
The COMFORT-SHORT study is a prospective, single-center, open-label pilot registry designed to investigate the safety and feasibility of OCT-guided stent optimization in applying short-term DAPT strategies. Patients with stable angina undergoing PCI with drug-eluting stent implantation will be enrolled. All participants will undergo OCT during PCI to evaluate stent deployment. Stent size and length will be determined based on OCT analysis, and final imaging will be reviewed to confirm whether the procedure meets predefined optimization criteria.
Patients whose stents are confirmed as optimized will be transitioned to 1 month of DAPT followed by clopidogrel monotherapy. Patients with suboptimal results (e.g., malapposition, medial dissection, under-expansion) will continue standard DAPT for 6-12 months, based on guideline recommendations and individual bleeding. Importantly, patients with non-optimized stents will not be excluded; they will be followed prospectively, and outcomes will be compared with those of optimized patients.
The primary endpoint is the incidence of net adverse clinical events (NACE) at 12 months, comparing short-term versus standard DAPT strategies according to stent optimization status. All enrolled patients will undergo scheduled follow-up at 1, 6, and 12 months after PCI.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This is a prospective, single-center, open-label study with a parallel assignment design. All patients undergo OCT-guided PCI. Based on OCT findings, patients are categorized into two groups: those with optimized stent results receive short-duration DAPT (1 month), while those with suboptimal stent results continue standard DAPT (6-12 months) according to guidelines. Outcomes will be compared between groups.
| Arm | Type | Receives |
|---|---|---|
| Short DAPT | Experimental | Drug: Short DAPT, Device: OCT-guided PCIPatients with optimized stent results confirmed by OCT will receive 1 month of dual antiplatelet therapy followed by clopidogrel monotherapy. |
| Standard DAPT | Active comparator | Drug: Standard DAPT, Device: OCT-guided PCIPatients with suboptimal stent results (malapposition, dissection, under-expansion) with high bleeding risk will continue dual antiplatelet therapy for 6 months, according to guideline recommendations. |
| Extended DAPT | Active comparator | Drug: Extended DAPT, Device: OCT-guided PCIPatients with suboptimal stent results and high ischemic risk, as judged by the operator, will remain on dual antiplatelet therapy for 12 months. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Short DAPTPatients receive aspirin and clopidogrel for 1 month after PCI. After 1 month, aspirin is discontinued and clopidogrel monotherapy is continued. | Drug | Short DAPT |
| Standard DAPTPatients with high bleeding risk will receive aspirin and clopidogrel for 6 months after PCI (unoptimization confirmed in OCT), followed by single antiplatelet therapy thereafter. | Drug | Standard DAPT |
| Extended DAPTPatients (with stet unoptimazation results in OCT imaging) receive aspirin and clopidogrel for 12 months after PCI. | Drug | Extended DAPT |
| OCT-guided PCIAll patients undergo percutaneous coronary intervention with mandatory intravascular imaging using optical coherence tomography to assess stent optimization (expansion, apposition, dissection). | Device | Extended DAPT, Short DAPT, Standard DAPT |
Primary outcome
Net Adverse Cardiovascular Events (NACE)
Time frame: 12 months after the index PCI
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.
8 secondary outcomes
Major Adverse Cardiovascular Events (MACE)
Time frame: 12 months after PCI
All bleeding events
Time frame: 12 months after the index PCI
All-cause death
Time frame: 12 months after the index PCI
Cardiac death
Time frame: 12 months after the index PCI
Myocardial infarction
Time frame: 12 months after the index PCI
Stent thrombosis
Time frame: 12 months
Repeat revascularization
Time frame: 12 months
Stroke
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Individual participant dataSharing planned: Undecided. Data sharing may be considered after study completion and publication of the main results, depending on institutional policies and participant privacy considerations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Short DAPT, Standard DAPT and Extended DAPT in people with Stable Angina and Coronary Artery Disease, run by Korea University Guro Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Soohyung Park, MD, PhD (+82-10-3105-3710, shp503@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Net Adverse Cardiovascular Events (NACE) (time frame: 12 months after the index PCI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.