None listed
Conditions
Interventions
Drug : In this randomized study, patients who are scheduled to undergo carotid artery stenting will give consent to participate in this study and receive a dual antiplatelet therapy, including aspirin
Sponsors
Samsung Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients =19 years (2) 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 going to be executed carotid artery stenting (3) High bleeding risk is defined as a BARC 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 (NASCET). **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. - =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, eGFR < 60ml/min per 1.73m2) - Liver disease (cirrhosis with portal hypertension) - Cerebral microbleeds = 5 - Stroke or transient ischemic attacks within 6 months - Incidence of nontraumatic intracerebral hemorrhage regardless of duration or incidence of traumatic intracerebral hemorrhage within 12 months
Exclusion criteria
Exclusion criteria: (1) Incidence of net clinical events, including cardiovascular and cerebrovascular accidents or major bleeding events, within 30 days following carotid artery stenting (2) Discontinuation of dual antiplatelet therapy within 30 days after carotid stent implantation (However, use of a single antiplatelet therapy within 7days due to acute infection and trauma is allowed, but dual antiplatelet therapy must be administered at 28 to 30 days after carotid stent implantation) (3) 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) (4) Aspirin or clopidogrel hypersensitivity (5) Pregnant or breastfeeding women (Women of childbearing age need to check for pregnancy through urine or blood tests before registering for clinical trials, and use appropriate contraceptives during clinical trials) (6) Patients requiring anticoagulation for =12 months (7) Patients requiring administration of other antiplatelet therapies (8) Patients who are participating in another intervention clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinically significant bleeding | — |
Secondary
| Measure | Time frame |
|---|---|
| Combined cardiovascular and cerebrovascular accidents | — |
Countries
Korea, Republic of
Contacts
Public ContactDayoung Kim
Samsung Medical Center
Outcome results
None listed