Discontinuation of Antiplatelet Agent After Drug-Coated Balloon Angioplasty in Stabilized Patients With High Bleeding Risk and Coronary Artery Disease

Status: Recruiting
Location: See all (17) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Republic of Korea
Korea University Ansan Hospital
NOT_YET_RECRUITING
Ansan
Keimyung University Dongsan Medical Center
NOT_YET_RECRUITING
Daegu
Gangneung Asan Hospital, University of Ulsan College of Medicine
NOT_YET_RECRUITING
Gangneung
Ilsan Paik hospital
NOT_YET_RECRUITING
Goyang
Chonnam National University Hospital, Chonnam National University Medical School
NOT_YET_RECRUITING
Gwangju
Chung-Ang University Gwangmyeong Hospital
NOT_YET_RECRUITING
Gwangmyeong
Catholic Kwandong University International St. Mary's Hospital
NOT_YET_RECRUITING
Incheon
Gachon Cardiovascular Research Institute, Gachon University
NOT_YET_RECRUITING
Incheon
Inha University Hospital
NOT_YET_RECRUITING
Incheon
Chonbuk National University Hospital and Chonbuk National University Medical School
NOT_YET_RECRUITING
Jeonju
Gyeongsang National University Hospital
NOT_YET_RECRUITING
Jinju
Kangbuk Samsung Hospital
NOT_YET_RECRUITING
Seoul
Korea University Guro Hospital
NOT_YET_RECRUITING
Seoul
Samsung Medical Center
RECRUITING
Seoul
SMG-SNU Boramae Medical Center
NOT_YET_RECRUITING
Seoul
Ajou University School of Medicine
NOT_YET_RECRUITING
Suwon
Uijeongbu St. Mary Hospital
NOT_YET_RECRUITING
Uijeongbu-si
Contact Information
Primary
Joo Myung Lee, MD, MPH, PhD
drone80@hanmail.net
82-2-3410-2575
Backup
Seung Hun Lee, MD, PhD
lsh8602@naver.com
82-10-6413-7449
Time Frame
Start Date: 2025-04-07
Estimated Completion Date: 2031-12-31
Participants
Target number of participants: 1200
Treatments
Experimental: 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.
Active_comparator: 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.
Related Therapeutic Areas
Sponsors
Collaborators: Chonnam National University Hospital
Leads: Samsung Medical Center

This content was sourced from clinicaltrials.gov

Similar Clinical Trials