Highest Efficacy of Dual Antiplatelet Therapy After Carotid Artery Stenting in High Bleeding Risk Patients

Ki vehet részt

• Patients ≥19 years
• Symptomatic patients with carotid artery stenosis* greater than 50% and asymptomatic patients with carotid artery stenosis* greater than 70% who are scheduled to undergo or who have undergone carotid artery stenting
• High bleeding risk is defined as a Bleeding Academic Research Consortium type 3 or 5 bleeding risk of ≥4% at 1 year or a risk of an intracranial hemorrhage (ICH) of ≥1% at 1 year, Patients who meet at least one of the criteria for high bleeding risk** below; The degree of stenosis is determined using the method performed in the North American Symptomatic Carotid Endarterectomy Trial; Criteria for high bleeding risk (≥ 1); Incidence of non-access site bleeding within 12 months prior to stenting (gastrointestinal tract or hematuria); Presence of BARC type 3 or 5 bleeding regardless of the onset time, but the cause has not been completely cured; Adults aged ≥75 years; Thrombocytopenia < 100,000/mm3 (based on the screening test); Blood clotting disorders that increase bleeding (Von Willebrand disease, factor VII, VIII, IX, and XI deficiency); Patients with anemia defined as hemoglobin <12g/dL in men and <11g/dL in women or patients who donated blood within 4 weeks (based on the screening test); Patients received steroids or NSAIDs for ≥4 weeks; Patients with active malignancy (except for nonmelanoma skin cancer); Renal disease (dialysis, transplantation, Estimated Glomerular Filtration Rate < 60ml/min per 1.73m2); Liver disease (cirrhosis with portal hypertension); Cerebral microbleeds ≥ 5; Stroke or transient ischemic attacks within 6 months or Transient amaurosis fugax; Incidence of nontraumatic intracerebral hemorrhage regardless of duration or incidence of traumatic intracerebral hemorrhage within 12 months

Ki nem vehet részt

• Coronary artery stenting or other vascular stenting or vascular recanalization within 1 year (Revascularization surgery that requires CABG(Coronary Artery Bypass Graft) and other dual antiplatelet therapy)
• Patients requiring administration of other antiplatelet therapies
• Incidence of net clinical events, including cardiovascular and cerebrovascular accidents or major bleeding events, within 30 days following carotid artery stenting
• Discontinuation of dual antiplatelet therapy within 30 days after carotid stent implantation (However, use of a single antiplatelet therapy within 7 days due to acute infection and trauma is allowed, but dual antiplatelet therapy must be administered at 28 to 30 days after carotid stent implantation)
• Aspirin or clopidogrel hypersensitivity
• Pregnant or breastfeeding women (Women of childbearing need to check for pregnancy using urine or blood tests before enrollment, and use appropriate contraception methods during the clinical trial period)
• Patients requiring anticoagulation for ≥12 months
• Patients who are participating in another intervention clinical trial