Related Experiment Video
Updated: Jan 11, 2026
The WATCHMAN Left Atrial Appendage Closure Device for Atrial Fibrillation
Published on: February 28, 2012
Rationale for and design of the REsolution of LEft VENTricular thrombus (RELEVENT) Trial
Graham S Hillis1, Jarryd S K Walker2, Thomas Gilbert3
1Department of Cardiology, Royal Perth Hospital and Medical School, University of Western Australia, Perth, Australia.
Insights
Direct oral anticoagulants (DOACs) are being explored as an alternative to warfarin for treating left ventricular (LV) thrombus. The RELEVENT trial will determine if DOACs are as effective and safe as warfarin in resolving LV thrombus.
Area of Science:
- Cardiology
- Thrombosis Management
- Clinical Trials
Background:
- Left ventricular (LV) thrombus, a complication of systolic dysfunction, elevates stroke risk.
- Warfarin has been the standard anticoagulant, but direct oral anticoagulants (DOACs) are increasingly used off-label.
- Limited randomized data exists on DOAC efficacy and safety for LV thrombus.
Purpose of the Study:
- To test the noninferiority of DOACs compared to warfarin for LV thrombus resolution.
- To evaluate the safety of DOACs versus warfarin, assessing rates of cardiovascular death, stroke, embolism, and major bleeding.
Main Methods:
- The RELEVENT trial is a prospective, randomized, noninferiority study.
- 216 patients with confirmed LV thrombus will be randomized 1:1 to warfarin or a DOAC for 12-14 weeks.
- Primary endpoint: thrombus resolution without major adverse cardiovascular events at 3 months; long-term follow-up for 3 years.
Main Results:
- Recruitment is ongoing in 16 centers across New Zealand and Australia.
- The study aims to enroll 216 patients.
- Primary endpoint data at 3 months is anticipated.
Conclusions:
- The RELEVENT trial will provide crucial data on the efficacy and safety of DOACs versus warfarin for LV thrombus.
- Findings will inform clinical practice regarding anticoagulant choice for LV thrombus.
- Long-term outcomes and management strategies will also be investigated.
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 3 years to obtain data on long-term management and outcomes.
Sites:
Recruitment to the RELEVENT trial is underway in 16 centers in New Zealand and Australia.
Conclusions:
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.
