Apixaban vs. Warfarin in Left Ventricular Thrombus: A Randomized, Noninferiority Trial
University of Arizona
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age ≥18 years * LV thrombus confirmed within 14 days prior to randomization by CMR or contrast TTE or cardiac CT; baseline CMR required pre-randomization (or ≤7 days post-randomization if clinically unavoidable) * Candidate for oral anticoagulation for ≥3 months * Able to provide informed consent. Exclusion Criteria: * Absolute indication for VKA (mechanical valve, moderate-severe rheumatic MS and antiphospholipid syndrome) or clear preference or contraindication for one of the study drugs precluding randomization (see below) * Antiphospholipid syndrome * Estimated CrC…
Interventions
- DrugApixaban
Apixaban 5 mg orally twice daily
- DrugWarfarin
Warfarin will be prescribed with dose adjustment to maintain INR 2.0-3.0.
Location
- Banner University Medical Center - TucsonTucson, Arizona