HOST - DAPT Duration According the Bleeding Risk (HOST-BR)

Seoul National University

Status and phase: Active, not recruiting; Phase 4

Conditions: Coronary Artery Disease; Stable Angina; Acute Myocardial Infarction

Treatments: Drug: Dual antiplatelet agent duration

Study type: Interventional

Funder types: Other

Identifiers

NCT05631769

2002-150-1105

Details and patient eligibility

About

• 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.

Enrollment: 4,900 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• Inclusion Criteria:

  1. 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.
  2. The patient in whom the Bleeding Risk (according to the ARC-HBR classification) can be calculated.
  3. The patient has a working diagnosis of coronary artery disease which has been treated with percutaneous coronary intervention.

• Exclusion Criteria:

  1. Hypersensitivity to aspirin or P2Y12 inhibitors
  2. Patients in whom coroanry artery disease has been decided to be medically managed without a coronary stent.
  3. Positive pregnancy test or is known to be pregnant
  4. 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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4,900 participants in 4 patient groups

HBR - 1M DAPT

Experimental group

Description:

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.

Treatment:

Drug: Dual antiplatelet agent duration

HBR - 3M DAPT

Active Comparator group

Description:

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.

Treatment:

Drug: Dual antiplatelet agent duration

LBR - 12M DAPT

Active Comparator group

Description:

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.

Treatment:

Drug: Dual antiplatelet agent duration

LBR - 3M DAPT

Experimental group

Description:

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.

Treatment:

Drug: Dual antiplatelet agent duration