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| Name | Class |
|---|---|
| Chonnam National University Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Major bleeding (BARC 2, 3, or 5 bleeding) | BARC 2, 3, or 5 bleeding | 1 year after last patient enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-oriented composite outcome | a composite of all-cause death, non-fatal myocardial infarction, and any revascularization | 1 year after last patient enrollment |
| Cardiovascular death | Cardiovascular death |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Ansan Hospital | Recruiting | Ansan | South Korea |
After completion of primary trial report, executive committee members will have discussion about sharing the individual participant data (IPD) upon reasonable requests,
After completion of primary trial report
Upon reasonable requests, executive committee members will have discussion about sharing the individual participant data (IPD).
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A prospective, multi-center, open-label, randomized controlled, and superiority trial.
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Clinical outcome assessment will be performed under blinded assessment about the allocated treatment 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. |
|
| 1 year after last patient enrollment |
| All-cause death | All-cause death | 1 year after last patient enrollment |
| Target-vessel myocardial infarction | Target-vessel myocardial infarction | 1 year after last patient enrollment |
| Non-fatal MI | Non-fatal MI | 1 year after last patient enrollment |
| Clinically indicated target-lesion revascularization (TLR) | Clinically indicated target-lesion revascularization (TLR) | 1 year after last patient enrollment |
| Clinically indicated target-vessel revascularization (TVR) | Clinically indicated target-vessel revascularization (TVR) | 1 year after last patient enrollment |
| Any revascularization | Any revascularization | 1 year after last patient enrollment |
| Cardiovascular death or target-vessel MI | Cardiovascular death or target-vessel MI | 1 year after last patient enrollment |
| All-cause death or non-fatal MI | All-cause death or non-fatal MI | 1 year after last patient enrollment |
| Target vessel failure | a composite of cardiovascular death, target-vessel MI, and clinically indicated target-vessel revascularization | 1 year after last patient enrollment |
| Severe major bleeding (BARC 3 or 5 bleeding) | BARC 3 or 5 bleeding | 1 year after last patient enrollment |
| Major bleeding (TIMI major bleeding) | TIMI major bleeding | 1 year after last patient enrollment |
| Cerebrovascular accident (CVA) | Cerebrovascular accident (CVA) including Ischemic stroke, Hemorrhagic stroke, or Transient ischemic attack (TIA) | 1 year after last patient enrollment |
| Samsung Medical Center |
| Principal Investigator |
| Keimyung University Dongsan Medical Center | Recruiting | Daegu | South Korea |
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| Gangneung Asan Hospital, University of Ulsan College of Medicine | Recruiting | Gangneung | South Korea |
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| Ilsan Paik hospital | Recruiting | Goyang | South Korea |
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| Chonnam National University Hospital, Chonnam National University Medical School | Recruiting | Gwangju | South Korea |
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| Chung-Ang University Gwangmyeong Hospital | Recruiting | Gwangmyeong | South Korea |
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| Catholic Kwandong University International St. Mary's Hospital | Recruiting | Incheon | South Korea |
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| Gachon Cardiovascular Research Institute, Gachon University | Recruiting | Incheon | South Korea |
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| Inha University Hospital | Recruiting | Incheon | South Korea |
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| Chonbuk National University Hospital and Chonbuk National University Medical School | Recruiting | Jeonju | South Korea |
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| Gyeongsang National University Hospital | Recruiting | Jinju | South Korea |
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| Chung-Ang University Hospital | Recruiting | Seoul | South Korea |
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| Kangbuk Samsung Hospital | Recruiting | Seoul | South Korea |
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| Korea University Guro Hospital | Recruiting | Seoul | South Korea |
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| Samsung Medical Center | Recruiting | Seoul | South Korea |
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| SMG-SNU Boramae Medical Center | Recruiting | Seoul | South Korea |
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| Ajou University School of Medicine | Recruiting | Suwon | South Korea |
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| Uijeongbu St. Mary Hospital | Recruiting | Uijeongbu-si | South Korea |
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| ID | Term |
|---|---|
| D023921 | Coronary Stenosis |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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