Shorter blood thinner course may be safer after carotid stenting for High-Risk patients
NCT ID NCT06276374
First seen Jun 27, 2026 · Last updated Jul 15, 2026 · Updated 2 times
Summary
This study looks at how long people at high risk of bleeding should take two blood thinners after having a carotid artery stent placed. About 1,556 participants will first take both aspirin and clopidogrel for 30 days, then be split into two groups: one continues both drugs for 11 more months, while the other switches to just one blood thinner. The goal is to see if the shorter dual therapy reduces serious bleeding while still preventing strokes and heart attacks.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 1,556 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2024
- Expected to finish
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Dec 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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19 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Patients ≥19 years 2. 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 3. 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 Exclusion Criteria: 1. Incidence of net clinical events, including cardiovascular and cerebrovascular accidents or major bleeding events, within 30 days following carotid artery stenting 2. 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) 3. 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) 4. Aspirin or clopidogrel hypersensitivity 5. 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) 6. Patients requiring anticoagulation for ≥12 months 7. Patients requiring administration of other antiplatelet therapies 8. Patients who are participating in another intervention clinical trial
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Samsung Medical Center
RECRUITINGSeoul, 06351, South Korea
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