Percutaneous Coronary InterventionNCT07398001
Discontinuation of Antiplatelet Therapy After Drug-Coated Balloon Treatment
A study testing Stop Antiplatelet and Continue Antiplatelet in people with Percutaneous Coronary Intervention and Antiplatelet Therapy, run by Ulsan University Hospital at 7 sites in South Korea.
Trial summary
The goal of this clinical trial is to evaluate the benefits and risks of discontinuing antiplatelet therapy on clinical outcomes in patients who previously underwent coronary intervention using a drug-coated balloon. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Percutaneous Coronary Intervention, Antiplatelet Therapy, Drug-coated Balloon
- What is being tested?
- Stop Antiplatelet and Continue Antiplatelet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,042 participants
- Where
- 7 sitesSouth Korea
- Study dates
- 12 Feb 2026to 31 Jul 2030
- 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
- Adults aged 19 years or older who are able to understand the risks, benefits, and treatment alternatives of the study and who provide written informed consent voluntarily.
- Patients who underwent drug-coated balloon treatment at least 12 months prior to enrollment.
- Patients who have not experienced major adverse cardiovascular events, including myocardial infarction, stroke, or target vessel revascularization, since the index DCB treatment.
- Patients who have not experienced major bleeding since the index DCB treatment.
- Patients who are receiving antiplatelet therapy at the time of enrollment.
Who cannot join
- Patients with concomitant vascular disease requiring long-term antiplatelet therapy.
- Patients with non-cardiac comorbid conditions that, in the judgment of the investigator, are associated with a life expectancy of less than 1 year or may result in poor compliance with the study protocol.
- Patients who are participating in another drug or coronary device clinical study at the time of enrollment.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
South Korea7 sites
Korea University Ansan Hospital
Ansan
Sunwon Kim, MD, sunwon11@hanmail.net
Kangwon National University Hospital
Chuncheon
Ae-Young Her, MD, +82-10-6375-3863, hermartha@hanmail.net
Kosin University Hospital
Pusan
Soo-Jin Kim, MD, circleabc@naver.com
Korea University Guro Hospital
Seoul
Dong Oh Kang, MD, gelly9@naver.com
Samsung Medical Center
Seoul
Joo Myung Lee, MD, drone80@hanmail.net
Ulsan Medical Center
Ulsan
Chang-Bae Sohn, MD, scb77@daum.net
Ulsan University Hospital
Ulsan
Eun-Seok Shin, MD, +82-10-6319-4025, sesim1989@gmail.com
About this study
The goal of this clinical trial is to evaluate the benefits and risks of discontinuing antiplatelet therapy on clinical outcomes in patients who previously underwent coronary intervention using a drug-coated balloon.
The main questions it aims to answer are:
Read more
Does stopping antiplatelet therapy after 12 months affect the risk of net adverse clinical events? Does stopping antiplatelet therapy reduce the risk of bleeding compared with continuing treatment?
Researchers will compare patients who discontinue antiplatelet therapy with patients who continue antiplatelet therapy to determine the impact on clinical outcomes during follow-up.
Participants will:
Be randomly assigned to either discontinue or continue antiplatelet therapy Receive routine clinical follow-up through clinic visits or telephone contacts Be monitored for cardiovascular events and bleeding outcomes over time
Read the detailed description
Coronary artery disease is a major cause of morbidity and mortality worldwide. Percutaneous coronary intervention is widely used for the treatment of coronary artery disease, traditionally involving implantation of drug-eluting stents. Although contemporary drug-eluting stents have improved safety and efficacy compared with earlier stent technologies, permanent metallic implants remain associated with long-term considerations, including restenosis, stent thrombosis, and the need for prolonged antiplatelet therapy.
Drug-coated balloon therapy represents an alternative revascularization strategy that delivers an antiproliferative drug to the coronary vessel wall without implantation of a permanent scaffold. This "leave-nothing-behind" approach has been adopted in specific clinical settings and has been increasingly applied in selected coronary lesions. The absence of a permanent implant may offer potential advantages with respect to long-term vessel healing and antiplatelet therapy management.
Bleeding complications after coronary intervention are clinically relevant and have been associated with adverse outcomes. Decisions regarding the duration of antiplatelet therapy require careful consideration of both ischemic and bleeding risks. While shorter durations of antiplatelet therapy have been explored following contemporary coronary interventions, optimal long-term antiplatelet strategies after drug-coated balloon-based procedures remain incompletely defined.
Limited data are available regarding the clinical outcomes associated with discontinuation of antiplatelet therapy beyond 12 months in patients who have undergone initial percutaneous coronary intervention using drug-coated balloon treatment and have remained clinically stable. As a result, uncertainty persists regarding the balance of potential benefits and risks of long-term antiplatelet therapy in this population.
This prospective, randomized, multicenter study is designed to compare clinical outcomes between patients who discontinue antiplatelet therapy and those who continue antiplatelet therapy after 12 months following drug-coated balloon-based percutaneous coronary intervention. The study aims to provide additional evidence to inform clinical decision-making regarding antiplatelet therapy management in patients treated with drug-coated balloons.
- Being tested
- Stop Antiplatelet, Continue Antiplatelet
- Keywords
- coronary artery disease, drug-coated balloon, percutaneous coronary intervention, antiplatelet therapy, clinical outcomes
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stop AntiplateletDrug
Antiplatelet discontinuation after DCB treatment
Continue AntiplateletDrug
Antiplatelet continuation after DCB treatment
| Study group | Role | What they receive |
|---|---|---|
| Stop Antiplatelet | Experimental | Antiplatelet discontinuation group Receives: Drug: Stop Antiplatelet |
| Continue Antiplatelet | Active comparator | Antiplatelet continuation group Receives: Drug: Continue Antiplatelet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Net adverse clinical events (NACE)
A composite of all-cause death, non-fatal myocardial infarction, clinically driven target vessel revascularization, and bleeding defined as Bleeding Academic Research Consortium (BARC) type 2 to 5.
Non-fatal myocardial infarction is defined as a myocardial infarction diagnosed using standard clinical, electrocardiographic, and biomarker criteria that does not result in death.
Measured: Up to 12 months after randomization
Secondary outcomes (10)
NACE
A composite of all-cause death, non-fatal myocardial infarction, clinically driven target vessel revascularization, and bleeding defined as Bleeding Academic Research Consortium (BARC) type 2 to 5.
Measured: Up to 24, 36 months after randomization
The single components of the primary endpoint
A composite of all-cause death, non-fatal myocardial infarction, clinically driven target vessel revascularization, and bleeding defined as Bleeding Academic Research Consortium (BARC) type 2 to 5.
Measured: Up to 12, 24, 36 months after randomization
Rate of cardiac death
Cardiac death is defined as death resulting from an immediate cardiac cause, including myocardial infarction, heart failure, fatal arrhythmia, or sudden cardiac death. Deaths of unknown cause or unwitnessed deaths without an identifiable non-cardiac cause are also classified as cardiac death. Deaths clearly attributable to non-cardiac causes, such as malignancy, infection, trauma, or other non-cardiovascular conditions, are not considered cardiac death.
Measured: Up to 12, 24, 36 months after randomization
Stroke (ischemic and hemorrhagic)
Stroke is defined as a new, sudden onset of a focal or global neurological deficit lasting 24 hours or longer, or resulting in death, with a vascular cause. Both ischemic stroke and hemorrhagic stroke are included. The diagnosis is confirmed by clinical assessment and supported by brain imaging when available. Transient ischemic attacks (TIA), defined as neurological symptoms resolving within 24 hours without evidence of infarction or hemorrhage, are not considered stroke.
Measured: Up to 12, 24, 36 months after randomization
Target lesion failure
A composite of cardiac death, target vessel-related myocardial infarction, or clinically indicated target lesion revascularization.
Measured: Up to 12, 24, 36 months after randomization
Angina severity measured with Seattle Angina Questionnaires
Angina severity is assessed using the Seattle Angina Questionnaire (SAQ), a validated, patient-reported questionnaire designed to measure the impact of angina on daily life. The questionnaire evaluates angina-related symptoms, physical limitation, and quality of life. Higher scores indicate fewer angina symptoms and better functional status. Changes in SAQ scores over time are used to assess angina severity during follow-up.
Measured: At baseline and 12 months after randomization
Cost-effectiveness
Cost-effectiveness is defined as an economic evaluation comparing the costs and clinical outcomes of the study treatment strategies. Direct medical costs related to treatment, follow-up care, hospitalizations, and management of clinical events are assessed and compared in relation to clinical outcomes during the follow-up period. Cost-effectiveness is evaluated to determine the relative economic value of discontinuing versus continuing antiplatelet therapy.
Measured: Up to 12, 24, 36 months after randomization
Sex difference in NACE
Sex differences are assessed by comparing the incidence of NACE between male and female participants during follow-up.
Measured: Up to 12, 24, 36 months after randomization
Comparison of NACE in DM patients
NACE in patients with diabetes mellitus is assessed as a composite of ischemic and bleeding events during follow-up after randomization.
Measured: Up to 12, 24, 36 months after randomization
NACE in patients with acute coronary syndrome
Acute coronary syndrome was defined as ST-segment elevation myocardial infarction, non-ST-segment elevation myocardial infarction, or unstable angina.
Measured: Up to 12, 24, 36 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start12 Feb 2026 (estimated)
- Primary completion11 Feb 2028 (estimated)
- Study completion31 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Percutaneous Coronary InterventionStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,042 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ulsan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eun-Seok Shin, Ulsan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07398001
- Sponsor's protocol ID
- 2025-04-042
- Status last verified
- Feb 2026
- First submitted
- 20 Jan 2026
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Only de-identified individual participant data necessary to reproduce the main analyses will be shared. Data sharing will be subject to approval of a research proposal and execution of a data use agreement.
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Discontinuation of Antiplatelet Therapy After Drug-Coated Balloon Treatment
- ClinicalTrials.gov ID
- NCT07398001
- Acronym / sponsor ID
- 2025-04-042
- Keywords
- coronary artery disease, drug-coated balloon, percutaneous coronary intervention, antiplatelet therapy, clinical outcomes
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,042 participants (estimated)
- Lead sponsor
- Ulsan University HospitalUniversity, hospital or other
- Study start
- 12 Feb 2026 (estimated)
- Primary completion
- 11 Feb 2028 (estimated)
- Study completion
- 31 Jul 2030 (estimated)
- First posted
- 9 Feb 2026 (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.
The goal of this clinical trial is to evaluate the benefits and risks of discontinuing antiplatelet therapy on clinical outcomes in patients who previously underwent coronary intervention using a drug-coated balloon.
The main questions it aims to answer are:
Does stopping antiplatelet therapy after 12 months affect the risk of net adverse clinical events? Does stopping antiplatelet therapy reduce the risk of bleeding compared with continuing treatment?
Researchers will compare patients who discontinue antiplatelet therapy with patients who continue antiplatelet therapy to determine the impact on clinical outcomes during follow-up.
Participants will:
Be randomly assigned to either discontinue or continue antiplatelet therapy Receive routine clinical follow-up through clinic visits or telephone contacts Be monitored for cardiovascular events and bleeding outcomes over time
Detailed description
Coronary artery disease is a major cause of morbidity and mortality worldwide. Percutaneous coronary intervention is widely used for the treatment of coronary artery disease, traditionally involving implantation of drug-eluting stents. Although contemporary drug-eluting stents have improved safety and efficacy compared with earlier stent technologies, permanent metallic implants remain associated with long-term considerations, including restenosis, stent thrombosis, and the need for prolonged antiplatelet therapy.
Drug-coated balloon therapy represents an alternative revascularization strategy that delivers an antiproliferative drug to the coronary vessel wall without implantation of a permanent scaffold. This "leave-nothing-behind" approach has been adopted in specific clinical settings and has been increasingly applied in selected coronary lesions. The absence of a permanent implant may offer potential advantages with respect to long-term vessel healing and antiplatelet therapy management.
Bleeding complications after coronary intervention are clinically relevant and have been associated with adverse outcomes. Decisions regarding the duration of antiplatelet therapy require careful consideration of both ischemic and bleeding risks. While shorter durations of antiplatelet therapy have been explored following contemporary coronary interventions, optimal long-term antiplatelet strategies after drug-coated balloon-based procedures remain incompletely defined.
Limited data are available regarding the clinical outcomes associated with discontinuation of antiplatelet therapy beyond 12 months in patients who have undergone initial percutaneous coronary intervention using drug-coated balloon treatment and have remained clinically stable. As a result, uncertainty persists regarding the balance of potential benefits and risks of long-term antiplatelet therapy in this population.
This prospective, randomized, multicenter study is designed to compare clinical outcomes between patients who discontinue antiplatelet therapy and those who continue antiplatelet therapy after 12 months following drug-coated balloon-based percutaneous coronary intervention. The study aims to provide additional evidence to inform clinical decision-making regarding antiplatelet therapy management in patients treated with drug-coated balloons.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stop Antiplatelet | Experimental | Drug: Stop AntiplateletAntiplatelet discontinuation group |
| Continue Antiplatelet | Active comparator | Drug: Continue AntiplateletAntiplatelet continuation group |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 19 years or older who are able to understand the risks, benefits, and treatment alternatives of the study and who provide written informed consent voluntarily.
- Patients who underwent drug-coated balloon treatment at least 12 months prior to enrollment.
- Patients who have not experienced major adverse cardiovascular events, including myocardial infarction, stroke, or target vessel revascularization, since the index DCB treatment.
- Patients who have not experienced major bleeding since the index DCB treatment.
- Patients who are receiving antiplatelet therapy at the time of enrollment.
Key exclusion criteria (3 listed)
- Patients with concomitant vascular disease requiring long-term antiplatelet therapy.
- Patients with non-cardiac comorbid conditions that, in the judgment of the investigator, are associated with a life expectancy of less than 1 year or may result in poor compliance with the study protocol.
- Patients who are participating in another drug or coronary device clinical study at the time of enrollment.
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 |
|---|---|---|
| Stop AntiplateletAntiplatelet discontinuation after DCB treatment | Drug | Stop Antiplatelet |
| Continue AntiplateletAntiplatelet continuation after DCB treatment | Drug | Continue Antiplatelet |
Primary outcome
Net adverse clinical events (NACE)
Time frame: Up to 12 months after randomization
A composite of all-cause death, non-fatal myocardial infarction, clinically driven target vessel revascularization, and bleeding defined as Bleeding Academic Research Consortium (BARC) type 2 to 5. Non-fatal myocardial infarction is defined as a myocardial infarction diagnosed using standard clinical, electrocardiographic, and biomarker criteria that does not result in death.
10 secondary outcomes
NACE
Time frame: Up to 24, 36 months after randomization
The single components of the primary endpoint
Time frame: Up to 12, 24, 36 months after randomization
Rate of cardiac death
Time frame: Up to 12, 24, 36 months after randomization
Stroke (ischemic and hemorrhagic)
Time frame: Up to 12, 24, 36 months after randomization
Target lesion failure
Time frame: Up to 12, 24, 36 months after randomization
Angina severity measured with Seattle Angina Questionnaires
Time frame: At baseline and 12 months after randomization
Cost-effectiveness
Time frame: Up to 12, 24, 36 months after randomization
Sex difference in NACE
Time frame: Up to 12, 24, 36 months after randomization
Comparison of NACE in DM patients
Time frame: Up to 12, 24, 36 months after randomization
NACE in patients with acute coronary syndrome
Time frame: Up to 12, 24, 36 months after randomization
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 9 Feb 2026.
- Individual participant dataSharing planned: Yes. Only de-identified individual participant data necessary to reproduce the main analyses will be shared. Data sharing will be subject to approval of a research proposal and execution of a data use agreement.
Related trials for Percutaneous Coronary Intervention
Not yet recruiting
Hs-CRP-Guided Colchicine Treatment Targets in Very-High-Risk Patients With Coronary Artery Disease After PCI (TARGET-CHD)
Coronary Artery Disease, Atherosclerotic Cardiovascular Disease (ASCVD)
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
Not yet recruiting
ADVA ACE Coronary Stent System in Coronary Artery Disease Patients (ADVANCE)
Coronary Artery Disease, De Novo Stenosis Lesion
Recruiting
Algorithm-based Tailoring of Dual Antiplatelet Therapy to Improve Outcomes Following Percutaneous Coronary Interventions
Percutaneous Coronary Intervention, Platelet Aggregation Inhibitors
RecruitingPhase 3
Safety and Efficacy of Very Short DAPT in Older Patients Undergoing PCI
Coronary Artery Disease (CAD), Percutaneous Coronary Intervention (PCI)
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.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stop Antiplatelet and Continue Antiplatelet in people with Percutaneous Coronary Intervention and Antiplatelet Therapy, run by Ulsan University Hospital at 7 sites 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 5 inclusion and 3 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: opening soon, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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 Eun-Seok Shin, MD (+82-10-6319-4025, sesim1989@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Net adverse clinical events (NACE) (time frame: Up to 12 months after randomization). 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 9 Feb 2026.