KCT0005356招募中未知
Harmonizing Optimal Strategy for Treatment of coronary artery diseases - DAPT duration according the Bleeding Risk
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 3,600
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •? Patients who have agreed to participate in the study among
- •adults aged 19 or older who are in the high-risk group of bleeding(HBR) after
- •the treatment of a coronary artery disease(CAD) with percutaneous coronary
- •intervetion(PCI) are targeted. The criteria for the HBR are as follows. 1)
- •Definitions of HBR: Patients are considered to be at HBR if at least 1 major or
- •2 minor criteria are met. ? Major criteria: Anticipated use of long-term oral
- •anticoagulation Severe or end-stage chronic kidney disease(CKD) (eGFR <30
- •mL/min) Hemoglobin(Hb) <11 g/dL Spontaneous bleeding requiring
- •hospitalization or transfusion in the past 6 months or at any time, if recurrent
- •Moderate or severe baseline thrombocytopenia (platelet count <100×109/L)
- •Chronic bleeding diathesis Liver cirrhosis with portal hypertension Active
- •malignancy (defined as diagnosis within 12 months and/or ongoing requirement for
- •treatment, excluding nonmelanoma skin cancer) within the past 12 months Previous
- •spontaneous intracranial hemorrhage(ICH) (at any time) or Previous traumatic ICH
- •within the past 12 months or Presence of a brain arteriovenous
- •malformation(bAVM) or Moderate or severe ischemic stroke (defined National
- •Institutes of Health Stroke Scale score =5) within the past 6 months
- •Nondeferrable major surgery on DAPT Recent major surgery or major trauma within
- •30 days before PCI ? Minor criteria: Age =75 years Moderate CKD (eGFR 30–59
- •mL/min) Hb 11–12.9 g/dL for men and 11–11.9 g/dL for women Spontaneous bleeding
- •requiring hospitalization or transfusion within the past 12 months not meeting
- •the major criterion Long-term use of oral nonsteroidal anti-inflammatory
- •drugs(NSAIDs) or steroids Any ischemic stroke at any time not meeting the major
- •criterion ? Those who meet the low bleeding risk(LBR) criteria below among CAD
- •patients who have undergone a PCI with a Resolute Onyx stent and who have agreed
- •to participate in clinical research. 2) The criteria of LBR are defined as those
- •that do not correspond to the major criteria of HBR above, and those that
- •satisfy the minor criteria are not more than one.
排除标准
- •1. Patients subject to DES treatment who belong to a
- •high-risk group of ischemic clinical events, who meet the following conditions:
- •A. STEMI(ST-segmentation elevation myocardial infarction) B. Patients with
- •hemodynamic instability due to a combination of cardiogenic shock or severe
- •acute heart failure. C. Myocardial infarction and stent thrombosis (or past
- •history, when this was strongly suspected) that occurred during the use of
- •anti-platelet drug. D. If the lesion subject to treatment is not 'de novo
- •lesion' (i.e., treatment for In-stent restenosis lesions) 2. Pregnant woman
- •3. Patients with allergic reactions to the following drugs or prohibited drug
- •use: aspirin, clopidogrel, prasugrel, ticaglor, heparin, cult chromium,
研究者
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