Actively Recruiting
Highest Efficacy of Dual Antiplatelet Therapy After Carotid Artery Stenting in High Bleeding Risk Patients
Led by Woo-Keun Seo · Updated on 2026-05-11
1556
Participants Needed
1
Research Sites
337 weeks
Total Duration
On this page
Sponsors
W
Woo-Keun Seo
Lead Sponsor
D
Dong-A ST Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
The optimal duration of dual antiplatelet therapy (DAPT) after carotid artery stenting (CAS) in patients at high bleeding risk (HBR) has not been established in randomized controlled trials. Current practice largely extrapolates from percutaneous coronary intervention (PCI) trials, but anatomical and procedural differences between coronary and carotid arteries limit the validity of this approach. The CHET trial is a multicenter, randomized, open-label, superiority trial designed to compare two DAPT durations after CAS in patients at HBR. After CAS, all eligible patients receive aspirin (100 mg daily) and clopidogrel (75 mg daily) for a 30-day enrichment period. Patients who remain free of net clinical events at day 30 are randomized 1:1 to either single antiplatelet therapy (SAPT; aspirin 100 mg or clopidogrel 75 mg daily, at the treating physician's discretion) for 11 months, or continued DAPT for 11 months. The primary hypothesis is that abbreviated DAPT followed by SAPT is superior to prolonged DAPT in reducing clinically significant bleeding (Bleeding Academic Research Consortium \[BARC\] type 2, 3, or 5) from 30 days to 12 months after CAS, while maintaining noninferiority in net clinical outcomes (composite of nonfatal stroke, nonfatal myocardial infarction, cardiovascular death, and major bleeding \[BARC type 3 or 5\]). A total of 1,556 participants (778 per group) will be enrolled across multiple comprehensive stroke centers in the Republic of Korea. Patients will be followed at 5 and 11 months after randomization, with subsequent annual follow-up (in-person or by telephone) until study completion to capture long-term clinical events.
CONDITIONS
Official Title
Highest Efficacy of Dual Antiplatelet Therapy After Carotid Artery Stenting in High Bleeding Risk Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 19 years or older
- Symptomatic carotid artery stenosis greater than 50% or asymptomatic stenosis greater than 70%, scheduled for or having undergone carotid artery stenting
- High bleeding risk defined by at least one of: recent non-access site bleeding, ongoing type 3 or 5 bleeding, age 75 years or older, low platelet count, blood clotting disorders, anemia or recent blood donation, use of steroids or NSAIDs for 4 weeks or more, active cancer (except nonmelanoma skin cancer), renal disease with low kidney function or dialysis, liver cirrhosis with portal hypertension, 5 or more cerebral microbleeds, recent stroke or transient ischemic attacks, or recent intracerebral hemorrhage
You will not qualify if you...
- Any major cardiovascular event or major bleeding within 30 days after carotid artery stenting
- Stopping dual antiplatelet therapy within 30 days after stenting (except short-term single therapy for acute infection or trauma)
- Coronary or other vascular stenting or revascularization surgery within the past year
- Known allergy to aspirin or clopidogrel
- Pregnant or breastfeeding women
- Need for anticoagulation therapy for 12 months or more
- Need for other antiplatelet therapies
- Participation in another intervention clinical trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
Research Team
W
Woo-Keun Seo, Ph.D
CONTACT
D
Dayoung Kim
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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