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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

To compare the safety of dual antiplatelet therapy with aspirin and clopidogrel and single antiplatelet therapy administered from 30 days to 12 months following carotid artery stenting on clinically significant bleeding and its prevention effects on net clinical events including combined cardiovascular and cerebrovascular accidents and major bleeding events in patients with carotid artery disease who are at high bleeding risk.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Republic of Korea
Samsung Medical Center
RECRUITING
Seoul
Contact Information
Primary
Woo-Keun Seo, Ph.D
mcastenosis@gmail.com
82-2-3410-0799
Time Frame
Start Date: 2024-07-15
Estimated Completion Date: 2030-12-31
Participants
Target number of participants: 1556
Treatments
Experimental: Single antiplatelet therapy (SAPT) group with aspirin or clopidogrel
1 month of dual antiplatelet therapy(100mg aspirin q.d. and 75mg clopidogrel q.d.)→ Randomization → 11 months of single antiplatelet therapy (100mg aspirin q.d. or 75mg clopidogrel q.d.)
Active_comparator: Dual antiplatelet therapy (DAPT) with aspirin and clopidogrel
1 month of dual antiplatelet therapy(100mg aspirin q.d. and 75mg clopidogrel q.d.) → Randomization → 11 months of dual antiplatelet therapy (100mg aspirin q.d. and 75mg clopidogrel q.d.)
Sponsors
Leads: Woo-Keun Seo

This content was sourced from clinicaltrials.gov

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