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Coronary Artery DiseasePhase 4HOST-BRNCT05631769

HOST - DAPT Duration According the Bleeding Risk

A Phase 4 study testing Dual antiplatelet agent duration in people with Coronary Artery Disease and Acute Myocardial Infarction, run by Seoul National University Hospital at 1 site in South Korea.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 years and older
What is being tested?
Dual antiplatelet agent duration
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4,900 participants
Where
1 siteSouth Korea
Study dates
24 Jul 2020to 31 Dec 2027
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.)

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Seoul National University Hospital

    Seoul

Other trials in South Korea

About this study

Official title: Harmonizing Optimal Strategy for Treatment of Coronary Artery Diseases - DAPT Duration According the Bleeding Risk

  • 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.
Being tested
Dual antiplatelet agent duration
Keywords
percutenous coronary intervention, dual antiplatelet therapy, bleeding risk
Medical subject headings
Coronary Artery Disease, Angina, Stable

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dual antiplatelet agent durationDrug

    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).

Study groups in NCT05631769
Study groupRoleWhat they receive
HBR - 1M DAPTExperimentalPatients 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.
Receives: Drug: Dual antiplatelet agent duration
HBR - 3M DAPTActive comparatorPatients 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.
Receives: Drug: Dual antiplatelet agent duration
LBR - 12M DAPTActive comparatorPatients 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.
Receives: Drug: Dual antiplatelet agent duration
LBR - 3M DAPTExperimentalPatients 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.
Receives: Drug: Dual antiplatelet agent duration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Net Adverse Clinical Events

    NACE; the composite of All-cause Death, Myocardial Infarction (MI), Stent thrombosis, Stroke, or Major Bleeding event

    Measured: 1-year after percutaneous coronary intervention

  2. Any bleeding event

    Bleeding events, defined by the BARC (Bleeding Academic Research Consortium) or ISTH (International Society on Thrombosis and Haemostasis) classification

    Measured: 1-year after percutaneous coronary intervention

  3. Major-Adverse Cardiac or Cerebral Events

    MACCE; the composite of Cardiac Death, Myocardial Infarction (MI), Stent thrombosis, Ischemic Stroke

    Measured: 1-year after percutaneous coronary intervention

Secondary outcomes (17)

  1. 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)'.

    Measured: 1-year after percutaneous coronary intervention

  2. Coronary thrombotic event

    Myocardial Infarction, Stent thrombosis

    Measured: 1-year after percutaneous coronary intervention

  3. All-cause death

    Death due to any cause

    Measured: 1-year after percutaneous coronary intervention

  4. Cardiac death

    Death due to cardiac cause

    Measured: 1-year after percutaneous coronary intervention

  5. Non-cardiac death

    Death due to non-cardiac cause

    Measured: 1-year after percutaneous coronary intervention

  6. Cardiovascular death

    Death due to cardiovascular cause

    Measured: 1-year after percutaneous coronary intervention

  7. Non-cardiovascular death

    Death due to non-cardiovascular cause

    Measured: 1-year after percutaneous coronary intervention

  8. Any myocardial infarction

    Any myocardial infarction event (Clinically irrelevant periprocedural myocardial infarction will NOT be added to analysis)

    Measured: 1-year after percutaneous coronary intervention

  9. Target vessel related myocardial infarction

    Any myocardial infarction related to the target vessel; according to the 'Academic Research Consortium-2 Consensus'

    Measured: 1-year after percutaneous coronary intervention

  10. Non-Target vessel related myocardial infarction

    Any myocardial infarction NOT related to the target vessel; according to the 'Academic Research Consortium-2 Consensus'

    Measured: 1-year after percutaneous coronary intervention

  11. Any revascularization

    Any coronary revascularization event

    Measured: 1-year after percutaneous coronary intervention

  12. Non-Target vessel revascularization

    Any revascularization event NOT related to the target vessel; according to the 'Academic Research Consortium-2 Consensus'

    Measured: 1-year after percutaneous coronary intervention

  13. Target vessel revascularization

    Any revascularization event related to the target vessel; according to the 'Academic Research Consortium-2 Consensus'

    Measured: 1-year after percutaneous coronary intervention

  14. Any stroke

    Any cerebrovascular event

    Measured: 1-year after percutaneous coronary intervention

  15. Any ischemic stroke

    Any ischemic cerebrovascular event

    Measured: 1-year after percutaneous coronary intervention

  16. Any hemorrhagic stroke

    Any hemorrhagic cerebrovascular event

    Measured: 1-year after percutaneous coronary intervention

  17. Major bleeding

    Major bleeding events, defined by the ISTH (International Society on Thrombosis and Haemostasis) classification

    Measured: 1-year after percutaneous coronary intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Nov 2022
  2. Study start24 Jul 2020
  3. Primary completion31 Dec 2024
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
4,900 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05631769
Sponsor's protocol ID
2002-150-1105
Acronym
HOST-BR
Status last verified
Jul 2025
First submitted
13 Nov 2022
Last updated
23 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • 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.

    PubMed 20626619

  • 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.

    PubMed 31116032

  • 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.

    PubMed 30597509

  • 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.

    PubMed 30784667

  • 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.

    PubMed 27026020

  • 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.

    PubMed 28886622

  • 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.

    PubMed 41631724

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dual antiplatelet agent duration in people with Coronary Artery Disease and Acute Myocardial Infarction, run by Seoul National University Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Net Adverse Clinical Events (time frame: 1-year after percutaneous coronary intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05631769, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2025.

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