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| Name | Class |
|---|---|
| Hanyang University Seoul Hospital | OTHER |
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HBR - 1M DAPT | Experimental | Patients who receive percutaneous coronary intervention for coronary artery disease, and who have High bleeding risk (defined according to the ARC-HBR criteria) will be randomized to 1 month or 3 month DAPT duration. |
|
| HBR - 3M DAPT | Active Comparator | Patients who receive percutaneous coronary intervention for coronary artery disease, and who have High bleeding risk (defined according to the ARC-HBR criteria) will be randomized to 1 month or 3 month DAPT duration. |
|
| LBR - 12M DAPT | Active Comparator | Patients who receive percutaneous coronary intervention for coronary artery disease, and who do NOT have High bleeding risk (defined according to the ARC-HBR criteria) will be randomized to 3 month or 12 month DAPT duration. |
|
| LBR - 3M DAPT | Experimental | Patients who receive percutaneous coronary intervention for coronary artery disease, and who do NOT have High bleeding risk (defined according to the ARC-HBR criteria) will be randomized to 3 month or 12 month DAPT duration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dual antiplatelet agent duration | Drug | Patients who receive percutaneous coronary intervention for coronary artery disease will be randomized to arms with different DAPT strategies. The randomization will be stratified according to the High bleeding risk (defined according to the ARC-HBR criteria). |
| Measure | Description | Time Frame |
|---|---|---|
| Net Adverse Clinical Events | NACE; the composite of All-cause Death, Myocardial Infarction (MI), Stent thrombosis, Stroke, or Major Bleeding event | 1-year after percutaneous coronary intervention |
| Any bleeding event | Bleeding events, defined by the BARC (Bleeding Academic Research Consortium) or ISTH (International Society on Thrombosis and Haemostasis) classification | 1-year after percutaneous coronary intervention |
| Major-Adverse Cardiac or Cerebral Events | MACCE; the composite of Cardiac Death, Myocardial Infarction (MI), Stent thrombosis, Ischemic Stroke | 1-year after percutaneous coronary intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Medication compliance | Medication compliance to the allocated DAPT regimen: A 'Pill count adherence' will be used to calculate medication compliance. This will be calculated by the following formula: '[(quantity dispensed)-(quantity remaining)] over (Prescribed number of tablets between dates of interview)'. | 1-year after percutaneous coronary intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20626619 | Background | Rodeghiero F, Tosetto A, Abshire T, Arnold DM, Coller B, James P, Neunert C, Lillicrap D; ISTH/SSC joint VWF and Perinatal/Pediatric Hemostasis Subcommittees Working Group. ISTH/SSC bleeding assessment tool: a standardized questionnaire and a proposal for a new bleeding score for inherited bleeding disorders. J Thromb Haemost. 2010 Sep;8(9):2063-5. doi: 10.1111/j.1538-7836.2010.03975.x. No abstract available. | |
| 31116032 |
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There is no pre-defined plan to share IPD, however, any relevant inquiry should be emailed to Dr. Hyo-Soo Kim or Dr. Jeehoon Kang.
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D060050 | Angina, Stable |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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|
| Coronary thrombotic event | Myocardial Infarction, Stent thrombosis | 1-year after percutaneous coronary intervention |
| All-cause death | Death due to any cause | 1-year after percutaneous coronary intervention |
| Cardiac death | Death due to cardiac cause | 1-year after percutaneous coronary intervention |
| Non-cardiac death | Death due to non-cardiac cause | 1-year after percutaneous coronary intervention |
| Cardiovascular death | Death due to cardiovascular cause | 1-year after percutaneous coronary intervention |
| Non-cardiovascular death | Death due to non-cardiovascular cause | 1-year after percutaneous coronary intervention |
| Any myocardial infarction | Any myocardial infarction event (Clinically irrelevant periprocedural myocardial infarction will NOT be added to analysis) | 1-year after percutaneous coronary intervention |
| Target vessel related myocardial infarction | Any myocardial infarction related to the target vessel; according to the 'Academic Research Consortium-2 Consensus' | 1-year after percutaneous coronary intervention |
| Non-Target vessel related myocardial infarction | Any myocardial infarction NOT related to the target vessel; according to the 'Academic Research Consortium-2 Consensus' | 1-year after percutaneous coronary intervention |
| Any revascularization | Any coronary revascularization event | 1-year after percutaneous coronary intervention |
| Non-Target vessel revascularization | Any revascularization event NOT related to the target vessel; according to the 'Academic Research Consortium-2 Consensus' | 1-year after percutaneous coronary intervention |
| Target vessel revascularization | Any revascularization event related to the target vessel; according to the 'Academic Research Consortium-2 Consensus' | 1-year after percutaneous coronary intervention |
| Any stroke | Any cerebrovascular event | 1-year after percutaneous coronary intervention |
| Any ischemic stroke | Any ischemic cerebrovascular event | 1-year after percutaneous coronary intervention |
| Any hemorrhagic stroke | Any hemorrhagic cerebrovascular event | 1-year after percutaneous coronary intervention |
| Major bleeding | Major bleeding events, defined by the ISTH (International Society on Thrombosis and Haemostasis) classification | 1-year after percutaneous coronary intervention |
| Background |
| Urban P, Mehran R, Colleran R, Angiolillo DJ, Byrne RA, Capodanno D, Cuisset T, Cutlip D, Eerdmans P, Eikelboom J, Farb A, Gibson CM, Gregson J, Haude M, James SK, Kim HS, Kimura T, Konishi A, Laschinger J, Leon MB, Magee PFA, Mitsutake Y, Mylotte D, Pocock S, Price MJ, Rao SV, Spitzer E, Stockbridge N, Valgimigli M, Varenne O, Windhoevel U, Yeh RW, Krucoff MW, Morice MC. Defining High Bleeding Risk in Patients Undergoing Percutaneous Coronary Intervention. Circulation. 2019 Jul 16;140(3):240-261. doi: 10.1161/CIRCULATIONAHA.119.040167. Epub 2019 May 22. |
| 30597509 | Background | Kang J, Park KW, Palmerini T, Stone GW, Lee MS, Colombo A, Chieffo A, Feres F, Abizaid A, Bhatt DL, Valgimigli M, Hong MK, Jang Y, Gilard M, Morice MC, Park DW, Park SJ, Jeong YH, Park J, Koo BK, Kim HS. Racial Differences in Ischaemia/Bleeding Risk Trade-Off during Anti-Platelet Therapy: Individual Patient Level Landmark Meta-Analysis from Seven RCTs. Thromb Haemost. 2019 Jan;119(1):149-162. doi: 10.1055/s-0038-1676545. Epub 2018 Dec 31. |
| 30784667 | Background | Costa F, Van Klaveren D, Feres F, James S, Raber L, Pilgrim T, Hong MK, Kim HS, Colombo A, Steg PG, Bhatt DL, Stone GW, Windecker S, Steyerberg EW, Valgimigli M; PRECISE-DAPT Study Investigators. Dual Antiplatelet Therapy Duration Based on Ischemic and Bleeding Risks After Coronary Stenting. J Am Coll Cardiol. 2019 Feb 26;73(7):741-754. doi: 10.1016/j.jacc.2018.11.048. |
| 27026020 | Background | Levine GN, Bates ER, Bittl JA, Brindis RG, Fihn SD, Fleisher LA, Granger CB, Lange RA, Mack MJ, Mauri L, Mehran R, Mukherjee D, Newby LK, O'Gara PT, Sabatine MS, Smith PK, Smith SC Jr. 2016 ACC/AHA Guideline Focused Update on Duration of Dual Antiplatelet Therapy in Patients With Coronary Artery Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines: An Update of the 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention, 2011 ACCF/AHA Guideline for Coronary Artery Bypass Graft Surgery, 2012 ACC/AHA/ACP/AATS/PCNA/SCAI/STS Guideline for the Diagnosis and Management of Patients With Stable Ischemic Heart Disease, 2013 ACCF/AHA Guideline for the Management of ST-Elevation Myocardial Infarction, 2014 AHA/ACC Guideline for the Management of Patients With Non-ST-Elevation Acute Coronary Syndromes, and 2014 ACC/AHA Guideline on Perioperative Cardiovascular Evaluation and Management of Patients Undergoing Noncardiac Surgery. Circulation. 2016 Sep 6;134(10):e123-55. doi: 10.1161/CIR.0000000000000404. Epub 2016 Mar 29. No abstract available. |
| 28886622 | Background | Valgimigli M, Bueno H, Byrne RA, Collet JP, Costa F, Jeppsson A, Juni P, Kastrati A, Kolh P, Mauri L, Montalescot G, Neumann FJ, Petricevic M, Roffi M, Steg PG, Windecker S, Zamorano JL, Levine GN; ESC Scientific Document Group; ESC Committee for Practice Guidelines (CPG); ESC National Cardiac Societies. 2017 ESC focused update on dual antiplatelet therapy in coronary artery disease developed in collaboration with EACTS: The Task Force for dual antiplatelet therapy in coronary artery disease of the European Society of Cardiology (ESC) and of the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J. 2018 Jan 14;39(3):213-260. doi: 10.1093/eurheartj/ehx419. No abstract available. |
| 41631724 | Derived | Kang J, Park KW, Han JK, Hwang D, Yang HM, Park S, Ahn HS, Hwang KK, Kim BG, Jeong JO, Ahn JH, Rhew JY, Park H, Kang TS, Koh JS, Park KT, Bang DW, Goh CW, Yoon HJ, Jo SH, Jang JY, Choi YJ, Lee SR, Lim YH, Kim HS; HOST-BR investigators. Dual antiplatelet therapy after percutaneous coronary intervention according to bleeding risk (HOST-BR): an open-label, multicentre, randomised clinical trial. Lancet. 2025 Nov 8;406(10516):2244-2256. doi: 10.1016/S0140-6736(25)01571-5. Epub 2025 Oct 23. |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D000787 | Angina Pectoris |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |