An interventional study of Discontinuation of antiplatelet agent group and Continuation of antiplatelet agent group in Chronic Coronary Syndrome, sponsored by Samsung Medical Center. Recruiting at 18 sites in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2025-11-28.
Sponsored by Samsung Medical Center · Not applicable, Interventional, and Treatment
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.
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.
302 studies on the registry are indexed under Coronary Stenosis; 63 are open to participants now.
This study's planned enrollment of 1,200 is above the median of 200 across 160 interventional studies indexed under Coronary Stenosis.
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Exclusion Criteria:
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
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
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.
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.
Major bleeding (BARC 2, 3, or 5 bleeding)
BARC 2, 3, or 5 bleeding
Time frame: 1 year after last patient enrollment
Patient-oriented composite outcome
a composite of all-cause death, non-fatal myocardial infarction, and any revascularization
Time frame: 1 year after last patient enrollment
Cardiovascular death
Cardiovascular death
Time frame: 1 year after last patient enrollment
All-cause death
All-cause death
Time frame: 1 year after last patient enrollment
Target-vessel myocardial infarction
Target-vessel myocardial infarction
Time frame: 1 year after last patient enrollment
Non-fatal MI
Non-fatal MI
Time frame: 1 year after last patient enrollment
Clinically indicated target-lesion revascularization (TLR)
Clinically indicated target-lesion revascularization (TLR)
Time frame: 1 year after last patient enrollment
Clinically indicated target-vessel revascularization (TVR)
Clinically indicated target-vessel revascularization (TVR)
Time frame: 1 year after last patient enrollment
Any revascularization
Any revascularization
Time frame: 1 year after last patient enrollment
Cardiovascular death or target-vessel MI
Cardiovascular death or target-vessel MI
Time frame: 1 year after last patient enrollment
All-cause death or non-fatal MI
All-cause death or non-fatal MI
Time frame: 1 year after last patient enrollment
Target vessel failure
a composite of cardiovascular death, target-vessel MI, and clinically indicated target-vessel revascularization
Time frame: 1 year after last patient enrollment
Severe major bleeding (BARC 3 or 5 bleeding)
BARC 3 or 5 bleeding
Time frame: 1 year after last patient enrollment
Major bleeding (TIMI major bleeding)
TIMI major bleeding
Time frame: 1 year after last patient enrollment
Cerebrovascular accident (CVA)
Cerebrovascular accident (CVA) including Ischemic stroke, Hemorrhagic stroke, or Transient ischemic attack (TIA)
Time frame: 1 year after last patient enrollment
Plan to share: Yes — After completion of primary trial report, executive committee members will have discussion about sharing the individual participant data (IPD) upon reasonable requests,
Supporting information: Study protocol, Sap, Csr
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