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Apixaban Versus Warfarin for Left Ventricular Thrombus

Study acronym: APEX
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study First Submitted
3,531 trials monitored
See 153 trials at risk
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.
Trial Details
NCT Number NCT07709780
Lead Sponsor University of Arizona
Conditions
(from sponsor)
Left Ventricular Thrombus
Related terms Stroke
Enrollment 218 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov