HOST - DAPT Duration According the Bleeding Risk

NCT05631769 | Active Not Recruiting Phase 4 DMC

• 1 other identifier: 2002-150-1105
• Study Type: interventional
• Target: 4,900
• Locations: 1 country
• Sites: 1

Brief Summary

• Dual antiplatelet agent therapy (DAPT) is essential in treating PCI patients. DAPT can minimize thrombotic adverse events that occur not only at the stented lesion, but along the whole coronary tree. However, DAPT has a critical side effect of increasing bleeding complications. Addressing the clinical imperatives of lowering bleeding while preserving ischemic benefit requires therapeutic strategies that decouple thrombotic from hemorrhagic risk.
• Recently, the ARC definition of high bleeding risk (HBR) has been published, so as to stress the need of optimal DAPT treatment in HBR patients. Due to the definitely higher bleeding risk in HBR patients, it would be rather more straight forward to titrate the optimal DAPT duration in these patients. In this line, many studies are in progress on HBR patients, with an ultra-short DAPT duration (i.e. Leaders free, Onyx ONE, Master DAPT, Xience 28, Xience 90, Evolve short DAPT trial, etc.).
• As a counteract to the definition of HBR, there is a concept of LBR. Due to the relatively vague ischemic/bleeding risk in LBR patients, balancing ischemic and bleeding complications post-PCI is more difficult in LBR patients, which may be a more important dilemma for clinicians. In this regards, limited evidence exists on the optimal duration of DAPT in LBR patients. Various previous studies that have evaluated the optimal DAPT in PCI populations, did not have the concept of HBR or LBR, making interpretation difficult.
• Therefore, this study is planning to compare the efficacy and safety of different DAPT durations, in patients stratified according to the ARB-HBR definition.

Conditions

Coronary Artery Disease; Acute Myocardial Infarction; Stable Angina

Keywords

percutenous coronary intervention; dual antiplatelet therapy; bleeding risk

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (17)

• Medication compliance

  1-year after percutaneous coronary intervention

• Coronary thrombotic event

  1-year after percutaneous coronary intervention

• All-cause death

  1-year after percutaneous coronary intervention

• Cardiac death

  1-year after percutaneous coronary intervention

• Non-cardiac death

  1-year after percutaneous coronary intervention

Study Arms (4)

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.

Drug: Dual antiplatelet agent 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.

Drug: Dual antiplatelet agent 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.

Drug: Dual antiplatelet agent 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.

Drug: Dual antiplatelet agent duration

Interventions

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).

HBR - 1M DAPT; HBR - 3M DAPT; LBR - 12M DAPT; LBR - 3M DAPT

Eligibility Criteria

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

You may qualify if:

• The patient agrees to participate in this study by signing the informed consent form. Alternatively, a legally authorized patient representative may agree to the patient's participation in this study and sign the informed consent form.
• The patient in whom the Bleeding Risk (according to the ARC-HBR classification) can be calculated.
• The patient has a working diagnosis of coronary artery disease which has been treated with percutaneous coronary intervention.

You may not qualify if:

• Hypersensitivity to aspirin or P2Y12 inhibitors
• Patients in whom coroanry artery disease has been decided to be medically managed without a coronary stent.
• Positive pregnancy test or is known to be pregnant
• Any other reason the investigator deems the subject to be unsuitable for the study (e.g., Any life-threatening condition with life expectancy less than 6months, etc.)

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Hanyang University Seoul Hospital: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (7)

• 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.

  PMID: 20626619 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.

  PMID: 31116032 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.

  PMID: 30597509 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.

  PMID: 30784667 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.

  PMID: 27026020 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.

  PMID: 28886622 BACKGROUND

• 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.

  PMID: 41631724 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Angina, Stable

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Internal Medicine

Study Record Dates

• First Submitted: November 13, 2022
• First Posted: November 30, 2022
• Study Start: July 24, 2020
• Primary Completion: December 31, 2024
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)