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

NCT06276374 | Recruiting

• 1 other identifier: SMC 2023-12-107
• Study Type: interventional
• Target: 1,556
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Carotid Artery Diseases

Outcome Measures

Primary Outcomes (1)

• Clinically significant bleeding

  Bleeding Academic Research Consortium type 2, 3, or 5

  From 30 days after carotid artery stenting until 12 months

Secondary Outcomes (1)

• Combined cardiovascular and cerebrovascular accidents

  From 30 days after carotid artery stenting until 12 months

Study Arms (2)

Single antiplatelet therapy (SAPT) group with aspirin or clopidogrel

EXPERIMENTAL

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.)

Drug: Patients who are scheduled to undergo carotid artery stenting

Dual antiplatelet therapy (DAPT) with aspirin and clopidogrel

ACTIVE COMPARATOR

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.)

Drug: Patients who are scheduled to undergo carotid artery stenting

Interventions

Patients who are scheduled to undergo carotid artery stenting DRUG

* Arm A : Single antiplatelet therapy (SAPT) 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.) * Arm B : 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.)

Also known as: Aspirin and,or Clopidogrel

Dual antiplatelet therapy (DAPT) with aspirin and clopidogrel; Single antiplatelet therapy (SAPT) group with aspirin or clopidogrel

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)
• 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)
• 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 requiring administration of other antiplatelet therapies
• Patients who are participating in another intervention clinical trial

Sponsors & Collaborators

• Woo-Keun Seo: lead

Study Sites (1)

Samsung Medical Center

Seoul, 06351, South Korea

RECRUITING

MeSH Terms

Conditions

Carotid Artery Diseases

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Woo-Keun Seo, Ph.D

CONTACT

82-2-3410-0799; mcastenosis@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 13, 2024
• First Posted: February 26, 2024
• Study Start: July 15, 2024
• Primary Completion (Estimated): November 30, 2029
• Study Completion (Estimated): December 31, 2030
• Last Updated: July 22, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)