Actively Recruiting

Phase Not Applicable
Age: 19Years +
All Genders
NCT06276374

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

Age: 19Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Samsung Medical Center

Seoul, South Korea, 06351

Actively Recruiting

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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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