Chronic Coronary SyndromeDCB-HBR-2NCT06742931
Drug-Coated Balloon Versus Drug-Eluting Stent for Treatment of De-Novo Coronary Lesions in Patients With High Bleeding Risk-2
A study testing Discontinuation of antiplatelet agent group and Continuation of antiplatelet agent group in people with Chronic Coronary Syndrome, run by Samsung Medical Center at 18 sites in South Korea.
Trial summary
A prospective, multi-center, open-label, randomized controlled, and superiority trial. The trial will compare clinical outcomes between discontinuation of antiplatelet agent and continuation of antiplatelet agent in HBR patients with chronic coronary syndrome treated by DCB angioplasty and standard duration of DAPT… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Chronic Coronary Syndrome
- What is being tested?
- Discontinuation of antiplatelet agent group and Continuation of antiplatelet agent group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 18 sitesSouth Korea
- Study dates
- 7 Apr 2025to 31 Dec 2031
- 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
- Subject must be at least 19 years of age
- Subject who is able to understand risks, benefits and treatment alternatives and sign informed consent voluntarily.
- Patients with chronic coronary syndrome and at least one de novo lesion of reference vessel size ≥2.25 mm, treated with DCB angioplasty
- Patients with high bleeding risk: one or more of the criteria listed A. Age ≥ 75 years old B. Baseline Hemoglobin <11 g/dl (or anemia requiring transfusion during the 4 weeks prior to randomization) C. Any prior intra-cerebral bleed D. Hospital admission for bleeding during the prior 12 months E. Non skin cancer diagnosed or treated < 3 years F. Planned daily NSAID (other than aspirin) or steroids for >30 days after PCI G. Planned surgery that would require interruption of DAPT (within next 12 months) H. Renal failure defined as calculated creatinine clearance <40 ml/min or on dialysis I. Hematological disorders (platelet count <100,000/mm3 or any coagulation disorder) J. Severe chronic liver disease defined as patients who have developed any of the following: variceal hemorrhage, ascites, hepatic encephalopathy or jaundice K. Expected non-compliance to secondary prevention medications after PCI for other medical reasons
- Patients who completed standard duration of DAPT (1-3months) and followed by maintenance of single antiplatelet agent (aspirin or P2Y12 inhibitor) for at least 1 year from index procedure.
- No bleeding (BARC 2, 3, or 5 bleeding) or ischemic events (cardiovascular death, non-fatal MI, or clinically-indicated repeat revascularization) for at least 1 year from index procedure.
Who cannot join
- Patients unable to provide consent
- Patients with acute myocardial infarction or unstable angina
- Patients with known intolerance to aspirin, P2Y12 inhibitors, or components of DCB
- Patients with indication of oral anticoagulant
- Patients with concomitant drug-eluting stent implantation during index PCI
- Patients with history of ischemic stroke or previous myocardial infarction
Show all 14Show fewer
- Patients with peripheral arterial occlusive disease
- Patients with angiographic findings of A. Left main coronary artery disease B. In-stent restenosis is the cause of target lesion C. Target lesion in bypass graft D. True bifurcation lesion that requires upfront 2-stenting E. Patients with residual stenosis on non-target vessels after PCI (>70% diameter stenosis or FFR≤0.80)
- Patients who have non-cardiac co-morbid conditions with life expectancy <1 year
- Patients who may result in protocol non-compliance (site investigator's medical judgment)
- Patients with cardiogenic shock or cardiac arrest
- Patients with severe left ventricular systolic dysfunction (ejection fraction <30%)
- Patients with severe valvular heart disease requiring open heart surgery
- Pregnant or lactating women
Trial locations and contacts
18 sites in 1 country. Contact the study team or a site near you to ask about taking part.
18 sites in 1 country
South Korea18 sites, 18 recruiting
- Recruiting
Korea University Ansan Hospital
Ansan
Sunwon Kim, MD, PhD, sunwon11@hanmail.net
Sunwon Kim, MD, PhD
- Recruiting
Keimyung University Dongsan Medical Center
Daegu
Hyuck-Jun Yoon, MD, PhD, hippsons@gmail.com
Hyuck-Jun Yoon, MD, PhD
- Recruiting
Gangneung Asan Hospital, University of Ulsan College of Medicine
Gangneung
Hanbit Park, MD, PhD, phb8012@gmail.com
Hanbit Park, MD, PhD
- Recruiting
Ilsan Paik hospital
Goyang
Joon-Hyung Doh, MD,PhD, joon.doh@gmail.com
Joon-Hyung Doh, MD,PhD
- Recruiting
Chonnam National University Hospital, Chonnam National University Medical School
Gwangju
Young Joon Hong, MD, PhD, hyj200@hanmail.net
Seung Hun Lee, MD, PhD, 82-10-6413-7449, lsh8602@naver.com
- Recruiting
Chung-Ang University Gwangmyeong Hospital
Gwangmyeong
Sang Yeub Lee, MD, PhD, louisahj@gmail.com
Sang Yeub Lee, MD, PhD
- Recruiting
Catholic Kwandong University International St. Mary's Hospital
Incheon
Hyung-Bok Park, MD, PhD, hyungbok7@gmail.com
Hyung-Bok Park, MD, PhD
- Recruiting
Gachon Cardiovascular Research Institute, Gachon University
Incheon
Albert Youngwoo Jang, MD, PhD, albert.jang.md@gmail.com
Albert Youngwoo Jang, MD, PhD
- Recruiting
Inha University Hospital
Incheon
Sang Don Park, MD, PhD, denki1@inha.ac.kr
Sang Don Park, MD, PhD
- Recruiting
Chonbuk National University Hospital and Chonbuk National University Medical School
Jeonju
Yisik Kim, MD, PhD, dr.kimesik@gmail.com
Yisik Kim, MD, PhD
- Recruiting
Gyeongsang National University Hospital
Jinju
Hangyul Kim, MD, PhD, 13medicine@naver.com
Jin-Sin Koh, MD, PhD, kjs0175@gmail.com
- Recruiting
Chung-Ang University Hospital
Seoul
Ho Youn Won, MD, PhD, nowhy@cau.ac.kr
Ho Youn Won, MD, PhD
- Recruiting
Kangbuk Samsung Hospital
Seoul
Jong-Young Lee, MD, PhD, jyleeheart@naver.com
Seung-Jae Lee, MD, PhD, sjjy1028@daum.net
- Recruiting
Korea University Guro Hospital
Seoul
Dong-Oh Kang, MD, PhD, gelly9@naver.com
Dong-Oh Kang, MD, PhD
- Recruiting
Samsung Medical Center
Seoul
Joo Myung Lee, MD, MPH, PhD, 82-2-3410-2575, drone80@hanmal.net
David Hong, MD, 82-2-3410-2575, hongdawi@naver.com
- Recruiting
SMG-SNU Boramae Medical Center
Seoul
Hyun Sung Joh, MD, PhD, wingx4@naver.com
Hyun Sung Joh, MD, PhD
- Recruiting
Ajou University School of Medicine
Suwon
Hong-Seok Lim, MD, PhD, hslimmd@hanmail.net
Hong-Seok Lim, MD, PhD
- Recruiting
Uijeongbu St. Mary Hospital
Uijeongbu-si
Seonghyeon Bu, MD, PhD, buseonghyeon@gmail.com
Chan Joon Kim, MD, PhD, godandsci@naver.com
About this study
Official title: Discontinuation of Antiplatelet Agent After Drug-Coated Balloon Angioplasty in Stabilized Patients With High Bleeding Risk and Coronary Artery Disease
A prospective, multi-center, open-label, randomized controlled, and superiority trial. The trial will compare clinical outcomes between discontinuation of antiplatelet agent and continuation of antiplatelet agent in HBR patients with chronic coronary syndrome treated by DCB angioplasty and standard duration of DAPT, followed by maintenance of single antiplatelet agent without clinical event for at least 1 year from the index procedure.
Read the detailed description
In patients with chronic coronary syndrome, the benefit of percutaneous coronary intervention (PCI) has been controversial for a survival benefit while reducing the risk of spontaneous myocardial infarction (MI) or anginal symptoms. Therefore, unlike patients with acute coronary syndrome, routine PCI with drug-eluting stents (DES) for patients with chronic coronary syndrome should be individualized, considering the risk of long term possibility of stent failure and the need for maintaining dual antiplatelet therapy (DAPT) for certain period due to permanent vascular implant and increased risk of bleeding, especially in patients with high bleeding risk (HBR). Drug-coated balloon (DCB), a novel treatment strategy, which has benefit of having shorter antiplatelet therapy duration due to the absence of metallic scaffolds and polymers, could be an alternative treatment for patients with chronic coronary syndrome, especially in patients with HBR. Given the expanding indications for DCB including de novo coronary artery lesions, shorter duration of DAPT, and potentially reduced risk of bleeding might be a reasonable treatment strategy in patients with HBR.
In current guidelines, standard duration of DAPT after PCI is recommended for 1 to 3 months in patients with HBR. Then, it is recommended as Class IA recommendation for maintaining single antiplatelet agent for lifelong as a secondary prevention, regardless of the devices used during PCI and the risk of patients' bleeding risk. However, it should be noted that the supporting evidence for lifelong maintenance of single antiplatelet agent were derived from previous randomized controlled trials conducted in patients with acute myocardial infarction or stroke. In addition, the supporting evidence for lifelong maintenance of single antiplatelet agent after PCI was derived from the recent randomized controlled trials using metallic stents including bare metal stent, 1st generation DES, or 2nd generation DES. The gap in the evidence is that no previous trial evaluated the need of lifelong maintenance of single antiplatelet agent in HBR patients with chronic coronary syndrome treated by DCB angioplasty after standard duration of DAPT. Furthermore, although recent trial have shown that long-term antiplatelet monotherapy with clopidogrel demonstrated better clinical outcomes than antiplatelet monotherapy with aspirin in patients with chronic coronary syndrome undergoing PCI with DES, there has been scarce data regarding long-term antiplatelet therapy for HBR patients with chronic coronary syndrome treated by DCB angioplasty after standard duration of DAPT.
On this background, the current trial aims to compare clinical outcomes between discontinuation of antiplatelet agent and continuation of antiplatelet agent in HBR patients with chronic coronary syndrome treated by DCB angioplasty and standard duration of DAPT, followed by maintenance of single antiplatelet agent without clinical event for at least 1 year from the index procedure. Having this evidence will be able to more establish the evidence for the post-adjunctive medical treatment in patients with HBR after DCB angioplasty.
- Conditions
- Chronic Coronary Syndrome
- Being tested
- Discontinuation of antiplatelet agent group, Continuation of antiplatelet agent group
- Keywords
- Coronary artery stenosis, Antiplatelet agent, Drug-coated balloon, Chronic coronary syndrome, Prognosis
- Medical subject headings
- Coronary Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Discontinuation of antiplatelet agent groupOther
In this group, antiplatelet monotherapy will be discontinued at the time of randomization. Randomization will be performed at 1 year from the index procedure using DCB angioplasty, standard duration of DAPT (1-3 months), and maintenance of antiplatelet monotherapy at least 1 year from the index procedure in patients with HBR and chronic coronary syndrome. In patients who are still under DAPT at 1 year from index DCB angioplasty, all antiplatelet agents will be discontinued after randomization.
Continuation of antiplatelet agent groupOther
In this group, lifelong antiplatelet monotherapy will be continued after the time of randomization. Randomization will be performed at 1 year from the index procedure using DCB angioplasty, standard duration of DAPT (1-3 months), and maintenance of antiplatelet monotherapy at least 1 year from the index procedure in patients with HBR and chronic coronary syndrome. In patients who are still under DAPT at 1 year from index DCB angioplasty, DAPT will be changed to single antiplatelet therapy (aspirin or clopidogrel). The choice between aspirin or clopidogrel will be determined by the physician's discretion.
| Study group | Role | What they receive |
|---|---|---|
| Discontinuation of antiplatelet agent group | Experimental | In this group, antiplatelet monotherapy will be discontinued at the time of randomization. Randomization will be performed at 1 year from the index procedure using DCB angioplasty, standard duration of DAPT (1-3 months), and maintenance of antiplatelet monotherapy at least 1 year from the index procedure in patients with HBR and chronic coronary syndrome. In patients who are still under DAPT at 1 year from index DCB angioplasty, all antiplatelet agents will be discontinued after randomization. Receives: Other: Discontinuation of antiplatelet agent group |
| Continuation of antiplatelet agent group | Active comparator | In this group, lifelong antiplatelet monotherapy will be continued after the time of randomization. Randomization will be performed at 1 year from the index procedure using DCB angioplasty, standard duration of DAPT (1-3 months), and maintenance of antiplatelet monotherapy at least 1 year from the index procedure in patients with HBR and chronic coronary syndrome. In patients who are still under DAPT at 1 year from index DCB angioplasty, DAPT will be changed to single antiplatelet therapy (aspirin or clopidogrel). The choice between aspirin or clopidogrel will be determined by the physician's discretion. Receives: Other: Continuation of antiplatelet agent group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major bleeding (BARC 2, 3, or 5 bleeding)
BARC 2, 3, or 5 bleeding
Measured: 1 year after last patient enrollment
Secondary outcomes (14)
Patient-oriented composite outcome
a composite of all-cause death, non-fatal myocardial infarction, and any revascularization
Measured: 1 year after last patient enrollment
Cardiovascular death
Cardiovascular death
Measured: 1 year after last patient enrollment
All-cause death
All-cause death
Measured: 1 year after last patient enrollment
Target-vessel myocardial infarction
Target-vessel myocardial infarction
Measured: 1 year after last patient enrollment
Non-fatal MI
Non-fatal MI
Measured: 1 year after last patient enrollment
Clinically indicated target-lesion revascularization (TLR)
Clinically indicated target-lesion revascularization (TLR)
Measured: 1 year after last patient enrollment
Clinically indicated target-vessel revascularization (TVR)
Clinically indicated target-vessel revascularization (TVR)
Measured: 1 year after last patient enrollment
Any revascularization
Any revascularization
Measured: 1 year after last patient enrollment
Cardiovascular death or target-vessel MI
Cardiovascular death or target-vessel MI
Measured: 1 year after last patient enrollment
All-cause death or non-fatal MI
All-cause death or non-fatal MI
Measured: 1 year after last patient enrollment
Target vessel failure
a composite of cardiovascular death, target-vessel MI, and clinically indicated target-vessel revascularization
Measured: 1 year after last patient enrollment
Severe major bleeding (BARC 3 or 5 bleeding)
BARC 3 or 5 bleeding
Measured: 1 year after last patient enrollment
Major bleeding (TIMI major bleeding)
TIMI major bleeding
Measured: 1 year after last patient enrollment
Cerebrovascular accident (CVA)
Cerebrovascular accident (CVA) including Ischemic stroke, Hemorrhagic stroke, or Transient ischemic attack (TIA)
Measured: 1 year after last patient enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2024
- Study start7 Apr 2025
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- 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
- Model description
- A prospective, multi-center, open-label, randomized controlled, and superiority trial.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Chonnam National University Hospital
- Responsible party
- Principal investigator, Joo Myung Lee, Samsung Medical Center
- Investigators
- Joo-Yong Hahn, MD, PhD, Study chair, Samsung Medical CenterYoung Bin Song, MD, PhD, Study chair, Samsung Medical CenterJoo Myung Lee, MD, MPH, PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06742931
- Sponsor's protocol ID
- NCT314316452025
- Acronym
- DCB-HBR-2
- Status last verified
- Nov 2025
- First submitted
- 15 Dec 2024
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After completion of primary trial report, executive committee members will have discussion about sharing the individual participant data (IPD) upon reasonable requests,
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Discontinuation of Antiplatelet Agent After Drug-Coated Balloon Angioplasty in Stabilized Patients With High Bleeding Risk and Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT06742931
- Acronym / sponsor ID
- DCB-HBR-2 / NCT314316452025
- Conditions
- Chronic Coronary Syndrome
- Keywords
- Coronary artery stenosis, Antiplatelet agent, Drug-coated balloon, Chronic coronary syndrome, Prognosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- Chonnam National University Hospital
- Study start
- 7 Apr 2025 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 19 Dec 2024 (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.
A prospective, multi-center, open-label, randomized controlled, and superiority trial. The trial will compare clinical outcomes between discontinuation of antiplatelet agent and continuation of antiplatelet agent in HBR patients with chronic coronary syndrome treated by DCB angioplasty and standard duration of DAPT, followed by maintenance of single antiplatelet agent without clinical event for at least 1 year from the index procedure.
Detailed description
In patients with chronic coronary syndrome, the benefit of percutaneous coronary intervention (PCI) has been controversial for a survival benefit while reducing the risk of spontaneous myocardial infarction (MI) or anginal symptoms. Therefore, unlike patients with acute coronary syndrome, routine PCI with drug-eluting stents (DES) for patients with chronic coronary syndrome should be individualized, considering the risk of long term possibility of stent failure and the need for maintaining dual antiplatelet therapy (DAPT) for certain period due to permanent vascular implant and increased risk of bleeding, especially in patients with high bleeding risk (HBR). Drug-coated balloon (DCB), a novel treatment strategy, which has benefit of having shorter antiplatelet therapy duration due to the absence of metallic scaffolds and polymers, could be an alternative treatment for patients with chronic coronary syndrome, especially in patients with HBR. Given the expanding indications for DCB including de novo coronary artery lesions, shorter duration of DAPT, and potentially reduced risk of bleeding might be a reasonable treatment strategy in patients with HBR.
In current guidelines, standard duration of DAPT after PCI is recommended for 1 to 3 months in patients with HBR. Then, it is recommended as Class IA recommendation for maintaining single antiplatelet agent for lifelong as a secondary prevention, regardless of the devices used during PCI and the risk of patients' bleeding risk. However, it should be noted that the supporting evidence for lifelong maintenance of single antiplatelet agent were derived from previous randomized controlled trials conducted in patients with acute myocardial infarction or stroke. In addition, the supporting evidence for lifelong maintenance of single antiplatelet agent after PCI was derived from the recent randomized controlled trials using metallic stents including bare metal stent, 1st generation DES, or 2nd generation DES. The gap in the evidence is that no previous trial evaluated the need of lifelong maintenance of single antiplatelet agent in HBR patients with chronic coronary syndrome treated by DCB angioplasty after standard duration of DAPT. Furthermore, although recent trial have shown that long-term antiplatelet monotherapy with clopidogrel demonstrated better clinical outcomes than antiplatelet monotherapy with aspirin in patients with chronic coronary syndrome undergoing PCI with DES, there has been scarce data regarding long-term antiplatelet therapy for HBR patients with chronic coronary syndrome treated by DCB angioplasty after standard duration of DAPT.
On this background, the current trial aims to compare clinical outcomes between discontinuation of antiplatelet agent and continuation of antiplatelet agent in HBR patients with chronic coronary syndrome treated by DCB angioplasty and standard duration of DAPT, followed by maintenance of single antiplatelet agent without clinical event for at least 1 year from the index procedure. Having this evidence will be able to more establish the evidence for the post-adjunctive medical treatment in patients with HBR after DCB angioplasty.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A prospective, multi-center, open-label, randomized controlled, and superiority trial.
| Arm | Type | Receives |
|---|---|---|
| Discontinuation of antiplatelet agent group | Experimental | Other: Discontinuation of antiplatelet agent groupIn this group, antiplatelet monotherapy will be discontinued at the time of randomization. Randomization will be performed at 1 year from the index procedure using DCB angioplasty, standard duration of DAPT (1-3 months), and maintenance of antiplatelet monotherapy at least 1 year from the index procedure in patients with HBR and chronic coronary syndrome. In patients who are still under DAPT at 1 year from index DCB angioplasty, all antiplatelet agents will be discontinued after randomization. |
| Continuation of antiplatelet agent group | Active comparator | Other: Continuation of antiplatelet agent groupIn this group, lifelong antiplatelet monotherapy will be continued after the time of randomization. Randomization will be performed at 1 year from the index procedure using DCB angioplasty, standard duration of DAPT (1-3 months), and maintenance of antiplatelet monotherapy at least 1 year from the index procedure in patients with HBR and chronic coronary syndrome. In patients who are still under DAPT at 1 year from index DCB angioplasty, DAPT will be changed to single antiplatelet therapy (aspirin or clopidogrel). The choice between aspirin or clopidogrel will be determined by the physician's discretion. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject must be at least 19 years of age
- Subject who is able to understand risks, benefits and treatment alternatives and sign informed consent voluntarily.
- Patients with chronic coronary syndrome and at least one de novo lesion of reference vessel size ≥2.25 mm, treated with DCB angioplasty
- Patients with high bleeding risk: one or more of the criteria listed A. Age ≥ 75 years old B. Baseline Hemoglobin <11 g/dl (or anemia requiring transfusion during the 4 weeks prior to randomization) C. Any prior intra-cerebral bleed D. Hospital admission for bleeding during the prior 12 months E. Non skin cancer diagnosed or treated < 3 years F. Planned daily NSAID (other than aspirin) or steroids for >30 days after PCI G. Planned surgery that would require interruption of DAPT (within next 12 months) H. Renal failure defined as calculated creatinine clearance <40 ml/min or on dialysis I. Hematological disorders (platelet count <100,000/mm3 or any coagulation disorder) J. Severe chronic liver disease defined as patients who have developed any of the following: variceal hemorrhage, ascites, hepatic encephalopathy or jaundice K. Expected non-compliance to secondary prevention medications after PCI for other medical reasons
- Patients who completed standard duration of DAPT (1-3months) and followed by maintenance of single antiplatelet agent (aspirin or P2Y12 inhibitor) for at least 1 year from index procedure.
Key exclusion criteria (14 listed)
- Patients unable to provide consent
- Patients with acute myocardial infarction or unstable angina
- Patients with known intolerance to aspirin, P2Y12 inhibitors, or components of DCB
- Patients with indication of oral anticoagulant
- Patients with concomitant drug-eluting stent implantation during index PCI
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 |
|---|---|---|
| Discontinuation of antiplatelet agent groupIn this group, antiplatelet monotherapy will be discontinued at the time of randomization. Randomization will be performed at 1 year from the index procedure using DCB angioplasty, standard duration of DAPT (1-3 months), and maintenance of antiplatelet monotherapy at least 1 year from the index procedure in patients with HBR and chronic coronary syndrome. In patients who are still under DAPT at 1 year from index DCB angioplasty, all antiplatelet agents will be discontinued after randomization. | Other | Discontinuation of antiplatelet agent group |
| Continuation of antiplatelet agent groupIn this group, lifelong antiplatelet monotherapy will be continued after the time of randomization. Randomization will be performed at 1 year from the index procedure using DCB angioplasty, standard duration of DAPT (1-3 months), and maintenance of antiplatelet monotherapy at least 1 year from the index procedure in patients with HBR and chronic coronary syndrome. In patients who are still under DAPT at 1 year from index DCB angioplasty, DAPT will be changed to single antiplatelet therapy (aspirin or clopidogrel). The choice between aspirin or clopidogrel will be determined by the physician's discretion. | Other | Continuation of antiplatelet agent group |
Primary outcome
Major bleeding (BARC 2, 3, or 5 bleeding)
Time frame: 1 year after last patient enrollment
BARC 2, 3, or 5 bleeding
14 secondary outcomes
Patient-oriented composite outcome
Time frame: 1 year after last patient enrollment
Cardiovascular death
Time frame: 1 year after last patient enrollment
All-cause death
Time frame: 1 year after last patient enrollment
Target-vessel myocardial infarction
Time frame: 1 year after last patient enrollment
Non-fatal MI
Time frame: 1 year after last patient enrollment
Clinically indicated target-lesion revascularization (TLR)
Time frame: 1 year after last patient enrollment
Clinically indicated target-vessel revascularization (TVR)
Time frame: 1 year after last patient enrollment
Any revascularization
Time frame: 1 year after last patient enrollment
Cardiovascular death or target-vessel MI
Time frame: 1 year after last patient enrollment
All-cause death or non-fatal MI
Time frame: 1 year after last patient enrollment
Target vessel failure
Time frame: 1 year after last patient enrollment
Severe major bleeding (BARC 3 or 5 bleeding)
Time frame: 1 year after last patient enrollment
Major bleeding (TIMI major bleeding)
Time frame: 1 year after last patient enrollment
Cerebrovascular accident (CVA)
Time frame: 1 year after last patient enrollment
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 28 Nov 2025.
- Individual participant dataSharing planned: Yes. After completion of primary trial report, executive committee members will have discussion about sharing the individual participant data (IPD) upon reasonable requests,
Related trials for Chronic Coronary Syndrome
Recruiting
Randomized Prospective Trial on the Cost-Effectiveness of Photon-Counting CT Versus Energy-Integrating Detector CT in Suspected Chronic Coronary Syndrome
Computed Tomography Angiography, Coronary Artery Disease
Not yet recruiting
Community Health Worker Nutrition Self-Management Support for Cardio-Kidney-Metabolic Health
Hypertension (HTN), CKD - Chronic Kidney Disease
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Not yet recruiting
Out-Patient Proactive Observation With Wearable-Assisted Tracking for Cardiovascular Health Management
Chronic Coronary Syndrome
Not yet recruiting
SWitching to Appropriate Prescription in Cardiovascular-Kidney-Metabolic Syndrome
Cardiovascular-kidney-metabolic Syndrome, Diabete Type 2
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.
Joo-Yong Hahn, MD, PhD study chair
Samsung Medical Center
Young Bin Song, MD, PhD study chair
Samsung Medical Center
Joo Myung Lee, MD, MPH, PhD principal investigator
Samsung Medical Center
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Discontinuation of antiplatelet agent group and Continuation of antiplatelet agent group in people with Chronic Coronary Syndrome, run by Samsung Medical Center at 18 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 6 inclusion and 14 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 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 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 Joo Myung Lee, MD, MPH, PhD (82-2-3410-2575, drone80@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major bleeding (BARC 2, 3, or 5 bleeding) (time frame: 1 year after last patient enrollment). 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 28 Nov 2025.