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Tests treatment safety and results for Carotid Artery Diseases
Official title Highest Efficacy of Dual Antiplatelet Therapy After Carotid Artery Stenting in High Bleeding Risk Patients
ClinicalTrials.gov ID: NCT06276374
What this study is testing
What is Intervention 1(DAPT): Drug: Aspirin 100mg + Clopidogrel 75mg. Intervention 2(SAPT): Drug: Asprin 100mg or Clopidogrel 75mg?
Intervention 1(DAPT): Drug: Aspirin 100mg + Clopidogrel 75mg. Intervention 2(SAPT): Drug: Asprin 100mg or Clopidogrel 75mg is an investigational medicine, given as an once-daily treatment applied to the skin, being studied as a potential treatment for carotid artery diseases.
Also referred to as Aspirin and,or Clopidogrel.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 and older
You may be able to join 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...
- 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...
- The degree of stenosis is determined using the method performed in the North American Symptomatic Carotid Endarterectomy Trial.
- Criteria for high bleeding risk (≥ 1)
You likely can't join if
- Incidence of net clinical events, including cardiovascular and cerebrovascular accidents or major bleeding events, within 30 days following carotid...
- Discontinuation of dual antiplatelet therapy within 30 days after carotid stent implantation (However, use of a single antiplatelet therapy within 7...
- Coronary artery stenting or other vascular stenting or vascular recanalization within 1 year (Revascularization surgery that requires CABG(Coronary...
- 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...
- Patients requiring anticoagulation for ≥12 months
See the full eligibility criteria
- 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...
- 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seoul, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.