Highest Efficacy of Dual Antiplatelet Therapy After Carotid Artery Stenting in High Bleeding Risk… (NCT06276374) | Clinical Trial Compass
RecruitingNot Applicable
Highest Efficacy of Dual Antiplatelet Therapy After Carotid Artery Stenting in High Bleeding Risk Patients
South Korea1,556 participantsStarted 2024-07-15
Plain-language summary
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.
Who can participate
Age range19 Years
SexALL
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Inclusion 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 criteria for high bleeding risk\*\* below
Exclusion criteria
✕. 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 antiplatelet therapy must be administered at 28 to 30 days after carotid stent implantation)
✕. 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)
What they're measuring
1
Clinically significant bleeding
Timeframe: From 30 days after carotid artery stenting until 12 months
✕. 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