Journal Article

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

Neill, Johanne, Selvanayagam, Joseph B., Ihdayhid, Abdul R., Ford, Thomas J., Gilbert, Thomas, Nielsen, Lene H., Stewart, Ralph A.H., Zaman, Sarah, Pemberton, James, Brieger, David B., Hillis, Graham S., Walker, Jarryd S.K., Kueh, Anthony S.H., Dhakshinamurthy, Vijay A., Whalley, Gillian A., Rajwani, Adil, Moragues, Jorge, Somaratne, Jithendra, Wong, Chiew, Maggiore, Paul, French, John K., Doherty, Erin, Sarathy, Kiran, Benatar, Jocelyne, Troughton, Richard W., Adamson, Philip D., Budgeon, Charley A.

2026

Overview

•Left ventricular (LV) thrombus is often treated using DOACs, but with limited randomized evidence (85 characters).•The RELEVENT trial tests the noninferiority of DOACs to warfarin for the treatment of LV thrombus (84 characters).•The primary outcome of the RELEVENT trial is thrombus resolution without adverse clinical events (84 characters).•The RELEVENT trial will inform clinicians and guidelines on the optimal management of LV thrombus (84 characters). 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. 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. 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 3 years to obtain data on long-term management and outcomes. Recruitment to the RELEVENT trial is underway in 16 centers in New Zealand and Australia. The RELEVENT trial will help clarify whether DOACs are noninferior to warfarin in the early treatment of LV thrombus. It will also generate important insights into the long-term management and outcomes for patients. [Display omitted]

• Publisher: Elsevier Inc,Elsevier Limited
• Subject: Administration, Oral / Anticoagulants / Anticoagulants - administration & dosage / Anticoagulants - therapeutic use / Bleeding / Blood clots / Cardiac arrhythmia / Cardiomyopathy / Clinical outcomes / Death / Drug dosages / Embolism / Embolisms / Embolization / Factor Xa Inhibitors - therapeutic use / Female / Health risks / Heart / Heart attacks / Heart Diseases - drug therapy / Heart Ventricles - diagnostic imaging / Humans / Ischemia / Molecular weight / Patient safety / Patients / Prospective Studies / Quality of life / Questionnaires / Randomized Controlled Trials as Topic / Stroke / Stroke - etiology / Stroke - prevention & control / Thromboembolism / Thrombosis / Thrombosis - drug therapy / Thrombosis - etiology / Ventricle / Warfarin / Warfarin - administration & dosage / Warfarin - therapeutic use