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

Launched by WOO-KEUN SEO · Feb 16, 2024

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ClinConnect Summary

This clinical trial is studying the safety and effectiveness of two different types of blood-thinning treatments, called dual antiplatelet therapy (which uses aspirin and clopidogrel) and single antiplatelet therapy (which uses just one of these medications). The trial focuses on patients who have carotid artery disease and are at high risk for bleeding after undergoing a procedure called carotid artery stenting. Researchers want to see which treatment helps prevent major bleeding and serious complications, like heart attacks or strokes, over a period of 30 days to 12 months.

To participate in this trial, individuals need to be at least 19 years old and have significant narrowing of the carotid arteries, either with symptoms or without. They must also be identified as high bleeding risk based on specific health conditions or past medical history. Participants will be monitored for any side effects and how well the treatments work. This trial is currently recruiting participants, and everyone, regardless of gender, is welcome to join as long as they meet the eligibility criteria.

Gender

ALL

Eligibility 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 who have undergone carotid artery stenting
• • 3. 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
• 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. Coronary artery stenting or other vascular stenting or vascular recanalization within 1 year
• • 3. Aspirin or clopidogrel hypersensitivity
• • 4. 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)
• • 5. Patients requiring anticoagulation for ≥12 months
• • 6. Patients requiring administration of other antiplatelet therapies
• • 7. Patients who are participating in another intervention clinical trial