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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
218
Apixaban 5 mg orally twice daily
Warfarin will be prescribed with dose adjustment to maintain INR 2.0-3.0.
Banner University Medical Center - Tucson
Tucson, Arizona, United States
RECRUITINGComplete Left Ventricular Thrombus Resolution at 3 Months
Proportion of participants with complete resolution of left ventricular thrombus at 3 months, assessed by cardiac magnetic resonance imaging. The primary noninferiority comparison will use the absolute between-group difference in the proportion of participants with complete thrombus resolution, apixaban minus warfarin.
Time frame: 3 months after randomization
Major Bleeding
Proportion of participants with major bleeding defined as BARC type 3 or 5 bleeding.
Time frame: 6 months
Change in LV Thrombus Volume
Change in thrombus volume assessed by CMR
Time frame: Baseline to 3, 6, or 12 months
Left Ventricular Remodeling
Change in left ventricular ejection fraction and left ventricular volumes on follow-up imaging.
Time frame: Baseline to 3, 6,12 months
Recurrent LV Thrombus
Proportion of participants with recurrent LV thrombus after documented resolution.
Time frame: 12 months
Ischemic Stroke
Proportion of participants with ischemic stroke.
Time frame: 12 months
Systemic embolism
Proportion of participants with systemic embolism
Time frame: 12 months
Cardiovascular Mortality
Proportion of participants with cardiovascular death.
Time frame: 12 months
All-Cause Mortality
Proportion of participants with death from any cause.
Time frame: 12 months
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