Rationale for and design of the REsolution of LEft VENTricular thrombus (RELEVENT) Trial

作者：Graham S. Hillis, J. A. Walker, Thomas Gilbert, Charley Budgeon, J. French, Joseph B. Selvanayagam, Vijay Dhakshinamurthy, Richard W. Troughton, Jorge Moragues, Abdul Rahman Ihdayhid, Thomas J. Ford, Sarah Zaman, Johanne Neill, Philip D Adamson, James Pemberton, Erin Doherty, Gillian Whalley, Kiran Sarathy, David Brieger, Chiew Wong, L H Nielsen, P. Maggiore, A. Kueh, J. Somaratne, Adil Rajwani, Jocelyne Benatar, Ralph Stewart · 发表于：American Heart Journal · 年份：2025 · DOI：10.1016/j.ahj.2025.107301 · 被引用次数：2 · 研究领域：Cardiac tumors and thrombi、Venous Thromboembolism Diagnosis and Management、Atrial Fibrillation Management and Outcomes

RATIONALE: Left ventricular (LV) thrombus is a consequence of systolic dysfunction and is associated with an increased risk of stroke and systemic embolism. Anticoagulation with warfarin has been the standard of care. However, following the widespread adoption of direct oral anticoagulants (DOACs) in other settings, these are increasingly used to treat LV thrombus, despite limited randomized data to support equivalent outcomes and safety. PRIMARY HYPOTHESIS: We hypothesize that DOACs will be noninferior to warfarin in the resolution of LV thrombus, without the occurrence of cardiovascular death, stroke, systemic embolism or major bleeding at 3-months. DESIGN: The REsolution of LEft VENTricular thrombus (RELEVENT) trial (ACTRN12618001254280) will test the noninferiority of DOACs compared to warfarin. This prospective trial will randomize 216 patients with best-available imaging confirmed LV thrombus, at a 1:1 ratio to either warfarin or a DOAC, for a duration of 12 to 14 weeks. Any DOAC approved for stroke prevention in atrial fibrillation may be used, according to local preference. The primary endpoint will be the resolution of the thrombus, without the occurrence of cardiovascular death, stroke, systemic embolism or major bleeding at 3-month follow-up. Secondary and other endpoints of interest include components of the primary outcome, changes to thrombus diameter, days alive and out of hospital, disability free survival and quality of life. Patients will be followed up for ...