Clinical trial NCT05631769: HOST - DAPT Duration According the Bleeding Risk
Official title: Harmonizing Optimal Strategy for Treatment of Coronary Artery Diseases - DAPT Duration According the Bleeding Risk
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Coronary Artery Disease
Acute Myocardial Infarction
Stable Angina
Keywords: percutenous coronary intervention
dual antiplatelet therapy
bleeding risk
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Hanyang University Seoul Hospital
First posted: 2022-11-30
Enrollment: 4900
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.)

Primary outcomes:
measure: Net Adverse Clinical Events
timeFrame: 1-year after percutaneous coronary intervention
measure: Any bleeding event
timeFrame: 1-year after percutaneous coronary intervention
measure: Major-Adverse Cardiac or Cerebral Events
timeFrame: 1-year after percutaneous coronary intervention
Secondary outcomes:
measure: Medication compliance
timeFrame: 1-year after percutaneous coronary intervention
measure: Coronary thrombotic event
timeFrame: 1-year after percutaneous coronary intervention
measure: All-cause death
timeFrame: 1-year after percutaneous coronary intervention
measure: Cardiac death
timeFrame: 1-year after percutaneous coronary intervention
measure: Non-cardiac death
timeFrame: 1-year after percutaneous coronary intervention
measure: Cardiovascular death
timeFrame: 1-year after percutaneous coronary intervention
measure: Non-cardiovascular death
timeFrame: 1-year after percutaneous coronary intervention
measure: Any myocardial infarction
timeFrame: 1-year after percutaneous coronary intervention
measure: Target vessel related myocardial infarction
timeFrame: 1-year after percutaneous coronary intervention
measure: Non-Target vessel related myocardial infarction
timeFrame: 1-year after percutaneous coronary intervention
measure: Any revascularization
timeFrame: 1-year after percutaneous coronary intervention
measure: Non-Target vessel revascularization
timeFrame: 1-year after percutaneous coronary intervention
measure: Target vessel revascularization
timeFrame: 1-year after percutaneous coronary intervention
measure: Any stroke
timeFrame: 1-year after percutaneous coronary intervention
measure: Any ischemic stroke
timeFrame: 1-year after percutaneous coronary intervention
measure: Any hemorrhagic stroke
timeFrame: 1-year after percutaneous coronary intervention
measure: Major bleeding
timeFrame: 1-year after percutaneous coronary intervention
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
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