Actively Recruiting
Led by Woo-Keun Seo · Updated on 2026-05-11
1556
Participants Needed
1
Research Sites
56 weeks
Total Duration
W
Woo-Keun Seo
Lead Sponsor
D
Dong-A ST Co., Ltd.
Collaborating Sponsor
Researchers are evaluating the best length of dual antiplatelet therapy (DAPT) after carotid artery stenting (CAS) in patients at high risk of bleeding. This trial compares a shorter DAPT course followed by single antiplatelet therapy (SAPT) against prolonged DAPT. The goal is to find if the shorter treatment reduces significant bleeding while maintaining similar protection against strokes, heart attacks, and cardiovascular death. The study is conducted as a multicenter, randomized, open-label trial with 1,556 participants in South Korea. Participants first receive aspirin (100 mg daily) and clopidogrel (75 mg daily) for 30 days after CAS. Those without clinical events during this period are randomly assigned to either continue DAPT for 11 months or switch to SAPT with aspirin or clopidogrel for 11 months. Treatment choice in the SAPT group depends on the physician's decision. Follow-up visits occur at 5 and 11 months post-randomization, with annual checks afterward until study completion. During the study, participants undergo scheduled outpatient visits to monitor clinical events, including bleeding and cardiovascular incidents. The primary outcome measured is the rate of clinically significant bleeding from 30 days to 12 months after CAS. Secondary outcomes include combined cardiovascular and cerebrovascular events. Safety oversight is provided by independent committees, and long-term data collection continues through phone or in-person follow-ups until the trial ends in 2030.
CONDITIONS
Highest Efficacy of Dual Antiplatelet Therapy After Carotid Artery Stenting in High Bleeding Risk Patients
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 month
Participants receive dual antiplatelet therapy with aspirin and clopidogrel for 1 month before randomization.
Visits as per routine clinical care during this period
Duration - 11 months
Participants are randomized to receive either single antiplatelet therapy with aspirin or clopidogrel, or continued dual antiplatelet therapy with aspirin and clopidogrel for 11 months.
Outpatient visits at 5 months and 11 months after randomization
Duration - Up to study completion in December 2029
Participants are followed annually through outpatient visits or telephone contact to capture long-term clinical events until study completion.
Annual outpatient visits or telephone contacts
Total: 1 location
1
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
W
Woo-Keun Seo, Ph.D
D
Dayoung Kim
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Hyung Jun Kim, Tae-Jin Song, Moo-Seok Park...
https://pubmed.ncbi.nlm.nih.gov/41802529