A CLINICAL TRIAL TO COMPARE THE EFFICACY, SAFETY, AND SUPERIORITY OF 1-MONTH OR 12-MONTH DUAL ANTIPLATELET THERAPY FOLLOWING CAROTID ARTERY STENTING (CHET)

초록

Background and Aims: Based on the lack of high-quality evidence on long-term dual antiplatelet drug therapy for these patients, this clinical trial aims to compare the safety and efficacy of dual antiplatelet therapy with aspirin and clopidogrel against single antiplatelet therapy administered from 30 days to 12 months following carotid artery stenting. Methods: Study Design: Multicenter, randomized, open-label trial. Subjects: The target sample size is 1,556 subjects, with 778 subjects in each group. Eligibility includes patients scheduled for carotid artery stenting with high bleeding risk, defined as BARC type 3 or 5 bleeding risk. Procedure: If no net clinical outcome event occurs within 30 days after carotid artery stenting, subjects will be randomized. Subjects will be randomly allocated to one of two groups in a 1:1 ratio: the study group (one month of dual antiplatelet therapy) and the control group (12 months of dual antiplatelet therapy). End-points: The incidence of clinically significant bleeding at Month 12 (primary safety endpoint) will be estimated using the Kaplan–Meier method. The incidence of combined cardiovascular and cerebrovascular accidents and major bleeding events at Month 12 (secondary efficacy endpoint) will also be estimated using the Kaplan–Meier method. Results: Current Status: A total of 26 sites in Korea are participating in this clinical trial. The first subject was enrolled on July 8, 2024. Registration: ClinicalTrials.gov NCT0627637 / CRIS: KCT0009259 Conclusions: This randomized clinical trial is anticipated to inform future clinical practice by clarifying the appropriate duration of dual antiplatelet therapy in patients undergoing carotid artery stenting.