Drug-Coated Balloon Versus Drug-Eluting Stent for Treatment of De-Novo Coronary Lesions in Patients With High Bleeding Risk-2

NCT06742931 | Recruiting DMC

• 1 other identifier: NCT314316452025
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 18

Brief 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, followed by maintenance of single antiplatelet agent without clinical event for at least 1 year from the index procedure.

Conditions

Chronic Coronary Syndrome

Keywords

Coronary artery stenosis; Antiplatelet agent; Drug-coated balloon; Chronic coronary syndrome; Prognosis

Outcome Measures

Primary Outcomes (1)

• Major bleeding (BARC 2, 3, or 5 bleeding)

  BARC 2, 3, or 5 bleeding

  1 year after last patient enrollment

Secondary Outcomes (14)

• Patient-oriented composite outcome

  1 year after last patient enrollment

• Cardiovascular death

  1 year after last patient enrollment

• All-cause death

  1 year after last patient enrollment

• Target-vessel myocardial infarction

  1 year after last patient enrollment

• Non-fatal MI

  1 year after last patient enrollment

Study Arms (2)

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.

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.

Other: Continuation of antiplatelet agent group

Interventions

Discontinuation of antiplatelet agent group OTHER

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

Continuation of antiplatelet agent group OTHER

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

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Samsung Medical Center: lead
• Chonnam National University Hospital: collaborator

Study Sites (18)

Korea University Ansan Hospital

Ansan, South Korea

RECRUITING

Keimyung University Dongsan Medical Center

Daegu, South Korea

RECRUITING

Gangneung Asan Hospital, University of Ulsan College of Medicine

Gangneung, South Korea

RECRUITING

Ilsan Paik hospital

Goyang, South Korea

RECRUITING

Chonnam National University Hospital, Chonnam National University Medical School

Gwangju, South Korea

RECRUITING

Chung-Ang University Gwangmyeong Hospital

Gwangmyeong, South Korea

RECRUITING

Catholic Kwandong University International St. Mary's Hospital

Incheon, South Korea

RECRUITING

Gachon Cardiovascular Research Institute, Gachon University

Incheon, South Korea

RECRUITING

Inha University Hospital

Incheon, South Korea

RECRUITING

Chonbuk National University Hospital and Chonbuk National University Medical School

Jeonju, South Korea

RECRUITING

Gyeongsang National University Hospital

Jinju, South Korea

RECRUITING

Chung-Ang University Hospital

Seoul, South Korea

RECRUITING

Kangbuk Samsung Hospital

Seoul, South Korea

RECRUITING

Korea University Guro Hospital

Seoul, South Korea

RECRUITING

Samsung Medical Center

Seoul, South Korea

RECRUITING

SMG-SNU Boramae Medical Center

Seoul, South Korea

RECRUITING

Ajou University School of Medicine

Suwon, South Korea

RECRUITING

Uijeongbu St. Mary Hospital

Uijeongbu-si, South Korea

RECRUITING

MeSH Terms

Conditions

Coronary Stenosis

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Joo-Yong Hahn, MD, PhD

  Samsung Medical Center

  STUDY CHAIR

• Young Bin Song, MD, PhD

  Samsung Medical Center

  STUDY CHAIR

• Joo Myung Lee, MD, MPH, PhD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joo Myung Lee, MD, MPH, PhD

CONTACT

82-2-3410-2575; drone80@hanmail.net

Seung Hun Lee, MD, PhD

CONTACT

82-10-6413-7449; lsh8602@naver.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Clinical outcome assessment will be performed under blinded assessment about the allocated treatment group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: A prospective, multi-center, open-label, randomized controlled, and superiority trial.

Study Record Dates

• First Submitted: December 15, 2024
• First Posted: December 19, 2024
• Study Start: April 7, 2025
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2031
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: After completion of primary trial report
• Access Criteria: Upon reasonable requests, executive committee members will have discussion about sharing the individual participant data (IPD).

Locations

KR (18)