None listed
Conditions
Interventions
Others : If a patient who has procedured a percutaneous coronary intervention(PCI) using the Xiance Sierra stent meets the criteria of the high bleeding risk(HBR), they are registered for HOST-HBR res
Sponsors
Seoul National University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? 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.
Exclusion criteria
Exclusion criteria: 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, sirolimus
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All-cause death, Any MI, Any stroke and Major bleeding events | — |
Secondary
| Measure | Time frame |
|---|---|
| Cardiovascular death, Any MI, Stent Thrombosis, Ischemic stroke;Any Bleeding | — |
Countries
Korea, Republic of
Contacts
Public ContactJeehoon Kang
Seoul National University Hospital
Outcome results
None listed