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Active, Not Recruiting

NCT Number: NCT05631769

HOST - 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

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

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Seoul National University Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • Inclusion Criteria:
  • 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.
  • Exclusion Criteria:
  • 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.)

Treatment and study plan

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).

Primary outcomes

  1. Net Adverse Clinical Events

    Time frame: 1-year after percutaneous coronary intervention

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

  2. Any bleeding event

    Time frame: 1-year after percutaneous coronary intervention

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

  3. Major-Adverse Cardiac or Cerebral Events

    Time frame: 1-year after percutaneous coronary intervention

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

Secondary outcomes

  1. Medication compliance

    Time frame: 1-year after percutaneous coronary intervention

    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)'.

  2. Coronary thrombotic event

    Time frame: 1-year after percutaneous coronary intervention

    Myocardial Infarction, Stent thrombosis

  3. All-cause death

    Time frame: 1-year after percutaneous coronary intervention

    Death due to any cause

  4. Cardiac death

    Time frame: 1-year after percutaneous coronary intervention

    Death due to cardiac cause

  5. Non-cardiac death

    Time frame: 1-year after percutaneous coronary intervention

    Death due to non-cardiac cause

  6. Cardiovascular death

    Time frame: 1-year after percutaneous coronary intervention

    Death due to cardiovascular cause

  7. Non-cardiovascular death

    Time frame: 1-year after percutaneous coronary intervention

    Death due to non-cardiovascular cause

  8. Any myocardial infarction

    Time frame: 1-year after percutaneous coronary intervention

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

  9. Target vessel related myocardial infarction

    Time frame: 1-year after percutaneous coronary intervention

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

  10. Non-Target vessel related myocardial infarction

    Time frame: 1-year after percutaneous coronary intervention

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

  11. Any revascularization

    Time frame: 1-year after percutaneous coronary intervention

    Any coronary revascularization event

  12. Non-Target vessel revascularization

    Time frame: 1-year after percutaneous coronary intervention

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

  13. Target vessel revascularization

    Time frame: 1-year after percutaneous coronary intervention

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

  14. Any stroke

    Time frame: 1-year after percutaneous coronary intervention

    Any cerebrovascular event

  15. Any ischemic stroke

    Time frame: 1-year after percutaneous coronary intervention

    Any ischemic cerebrovascular event

  16. Any hemorrhagic stroke

    Time frame: 1-year after percutaneous coronary intervention

    Any hemorrhagic cerebrovascular event

  17. Major bleeding

    Time frame: 1-year after percutaneous coronary intervention

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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Hanyang University Seoul Hospital

Registry information

Official study title

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

Acronym: HOST-BR

Important dates

Study start
2020
Primary completion
2024
Study completion
2027
First posted
Nov 30, 2022
Registry last updated
Jul 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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