Apixaban Versus Warfarin for Left Ventricular Thrombus
NCT07709780 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 218
Last updated 2026-07-17
Summary
Left ventricular thrombus is a blood clot that forms in the left ventricle and is associated with risk of systemic embolism and ischemic stroke. Warfarin has historically been used for anticoagulation in this condition, but it requires frequent international normalized ratio monitoring and is affected by dietary and drug interactions. Apixaban is a direct oral factor Xa inhibitor with fixed dosing and no routine anticoagulation monitoring requirement, and it is increasingly used in clinical practice for left ventricular thrombus, although definitive randomized evidence remains limited.
This randomized, noninferiority trial will compare apixaban with warfarin for treatment of left ventricular thrombus. Eligible adults with recently confirmed left ventricular thrombus will be randomized 1:1 to apixaban or warfarin. The primary endpoint is complete left ventricular thrombus resolution at 3 months assessed by cardiac magnetic resonance imaging. Participants will be followed through 12 months for thrombus-related, bleeding, cardiovascular, and mortality outcomes.
Conditions
- Left Ventricular Thrombus
Interventions
- DRUG
-
Apixaban
Apixaban 5 mg orally twice daily
- DRUG
-
Warfarin
Warfarin will be prescribed with dose adjustment to maintain INR 2.0-3.0.
Sponsors & Collaborators
-
University of Arizona
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-06-22
- Primary Completion
- 2028-07-01
- Completion
- 2029-07-01
- FDA Drug
- Yes
Countries
- United States
Study Locations
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