Comparing antiplatelet therapies after carotid artery stenting in high bleeding risk patients

Clinical Trial to Obtain the Highest Efficacy of Dual Antiplatelet Therapy After Carotid Artery Stenting in High Bleeding Risk Patients

This study is testing whether a combination of two blood-thinning medications is safer and more effective than just one for patients with carotid artery disease who have a high risk of bleeding after getting a stent.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 1556 (estimated)
• Ages: 19 Years and up
• Sex: All
• Sponsor: Samsung Medical Center (other)
• Locations: 1 site (Seoul)
• Trial ID: NCT06276374 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the safety and efficacy of dual antiplatelet therapy (DAPT) versus single antiplatelet therapy (SAPT) in patients with carotid artery disease who are at high risk for bleeding. Participants will be randomly assigned to receive either one month of DAPT followed by 11 months of SAPT or continue with DAPT for the entire 12 months post-stenting. The primary focus is on clinically significant bleeding events and the prevention of cardiovascular and cerebrovascular accidents. The study will include patients aged 19 and older with significant carotid artery stenosis scheduled for stenting.

Who should consider this trial

Good fit: Ideal candidates are patients aged 19 and older with symptomatic carotid artery stenosis greater than 50% or asymptomatic stenosis greater than 70%, who are at high bleeding risk.

Not a fit: Patients who do not meet the criteria for high bleeding risk or those with less than 50% carotid artery stenosis may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved management strategies for high bleeding risk patients undergoing carotid artery stenting, potentially reducing adverse events.

How similar studies have performed: Previous studies have shown varying results with antiplatelet therapies in similar populations, but this specific comparison in high bleeding risk patients is relatively novel.

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. 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)
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 need to check for pregnancy using urine or blood tests before enrollment, and use appropriate contraception methods during the clinical trial period)
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

Where this trial is running

Seoul

• Samsung Medical Center — Seoul, South Korea (RECRUITING)

Study contacts

• Study coordinator: Woo-Keun Seo, Ph.D

Conditions: Carotid Artery Diseases, Carotid Artery Stenting, Dual Antiplatelet Therapy, High Bleeding Risk, Aspirin, Clopidogrel, BARC bleeding, Stroke prevention