Drug-Coated Balloon Versus Drug-Eluting Stent for Treatment of De-Novo Coronary Lesions in Patients With High Bleeding Risk-2
NCT ID: NCT06742931
Last Updated: 2025-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1200 participants
INTERVENTIONAL
2025-04-07
2031-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Discontinuation of antiplatelet agent group
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.
Discontinuation of antiplatelet agent group
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 group
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.
Continuation of antiplatelet agent group
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.
Interventions
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Discontinuation of antiplatelet agent group
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 group
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.
Eligibility Criteria
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Inclusion Criteria
2. Subject who is able to understand risks, benefits and treatment alternatives and sign informed consent voluntarily.
3. Patients with chronic coronary syndrome and at least one de novo lesion of reference vessel size ≥2.25 mm, treated with DCB angioplasty
4. 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
5. 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.
6. 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.
Exclusion Criteria
2. Patients with acute myocardial infarction or unstable angina
3. Patients with known intolerance to aspirin, P2Y12 inhibitors, or components of DCB
4. Patients with indication of oral anticoagulant
5. Patients with concomitant drug-eluting stent implantation during index PCI
6. Patients with history of ischemic stroke or previous myocardial infarction
7. Patients with peripheral arterial occlusive disease
8. 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)
9. Patients who have non-cardiac co-morbid conditions with life expectancy \<1 year
10. Patients who may result in protocol non-compliance (site investigator's medical judgment)
11. Patients with cardiogenic shock or cardiac arrest
12. Patients with severe left ventricular systolic dysfunction (ejection fraction \<30%)
13. Patients with severe valvular heart disease requiring open heart surgery
14. Pregnant or lactating women
19 Years
ALL
No
Sponsors
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Chonnam National University Hospital
OTHER
Samsung Medical Center
OTHER
Responsible Party
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Joo Myung Lee
Associate Professor
Principal Investigators
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Joo-Yong Hahn, MD, PhD
Role: STUDY_CHAIR
Samsung Medical Center
Young Bin Song, MD, PhD
Role: STUDY_CHAIR
Samsung Medical Center
Joo Myung Lee, MD, MPH, PhD
Role: PRINCIPAL_INVESTIGATOR
Samsung Medical Center
Locations
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Korea University Ansan Hospital
Ansan, , South Korea
Keimyung University Dongsan Medical Center
Daegu, , South Korea
Gangneung Asan Hospital, University of Ulsan College of Medicine
Gangneung, , South Korea
Ilsan Paik hospital
Goyang, , South Korea
Chonnam National University Hospital, Chonnam National University Medical School
Gwangju, , South Korea
Chung-Ang University Gwangmyeong Hospital
Gwangmyeong, , South Korea
Catholic Kwandong University International St. Mary's Hospital
Incheon, , South Korea
Gachon Cardiovascular Research Institute, Gachon University
Incheon, , South Korea
Inha University Hospital
Incheon, , South Korea
Chonbuk National University Hospital and Chonbuk National University Medical School
Jeonju, , South Korea
Gyeongsang National University Hospital
Jinju, , South Korea
Chung-Ang University Hospital
Seoul, , South Korea
Kangbuk Samsung Hospital
Seoul, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
SMG-SNU Boramae Medical Center
Seoul, , South Korea
Ajou University School of Medicine
Suwon, , South Korea
Uijeongbu St. Mary Hospital
Uijeongbu-si, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NCT314316452025
Identifier Type: -
Identifier Source: org_study_id
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