Harmonizing Optimal Strategy for Treatment of Coronary Artery Diseases - DAPT Duration According the Bleeding Risk
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 4,900
- 试验地点
- 1
- 主要终点
- Net Adverse Clinical Events
研究概览
简要总结
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.)
研究组 & 干预措施
HBR - 1M DAPT
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.
干预措施: Dual antiplatelet agent duration (Drug)
HBR - 3M DAPT
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.
干预措施: Dual antiplatelet agent duration (Drug)
LBR - 12M DAPT
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.
干预措施: Dual antiplatelet agent duration (Drug)
LBR - 3M DAPT
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.
干预措施: Dual antiplatelet agent duration (Drug)
结局指标
主要结局
Net Adverse Clinical Events
时间窗: 1-year after percutaneous coronary intervention
NACE; the composite of All-cause Death, Myocardial Infarction (MI), Stent thrombosis, Stroke, or Major Bleeding event
Any bleeding event
时间窗: 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
Major-Adverse Cardiac or Cerebral Events
时间窗: 1-year after percutaneous coronary intervention
MACCE; the composite of Cardiac Death, Myocardial Infarction (MI), Stent thrombosis, Ischemic Stroke
次要结局
- 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)
- Cardiovascular death(1-year after percutaneous coronary intervention)
- Non-cardiovascular death(1-year after percutaneous coronary intervention)
- Any myocardial infarction(1-year after percutaneous coronary intervention)
- Target vessel related myocardial infarction(1-year after percutaneous coronary intervention)
- Non-Target vessel related myocardial infarction(1-year after percutaneous coronary intervention)
- Any revascularization(1-year after percutaneous coronary intervention)
- Non-Target vessel revascularization(1-year after percutaneous coronary intervention)
- Target vessel revascularization(1-year after percutaneous coronary intervention)
- Any stroke(1-year after percutaneous coronary intervention)
- Any ischemic stroke(1-year after percutaneous coronary intervention)
- Any hemorrhagic stroke(1-year after percutaneous coronary intervention)
- Major bleeding(1-year after percutaneous coronary intervention)
研究者
Hyo-Soo Kim
Professor, Department of Internal Medicine
Seoul National University Hospital