Comparing Apixaban and Warfarin for Treating Left Ventricular Blood Clots Using Cardiac MRI in a Randomized Study

What this Trial Is About

Researchers are evaluating apixaban compared to warfarin for treating left ventricular thrombus, a blood clot in the left heart chamber that can cause serious complications like stroke. This phase 3 randomized trial aims to determine if apixaban is not worse than warfarin in resolving these clots within three months. The trial addresses the limitations of warfarin, which requires frequent blood monitoring and is affected by diet and other drugs, while apixaban offers fixed dosing without routine monitoring. Participants will be randomly assigned to receive either oral apixaban 5 mg twice daily or dose-adjusted warfarin to maintain a specific blood clotting range INR 2.0-3.0. Treatment and follow-up will extend for at least three months, with ongoing monitoring through 12 months for clot resolution, bleeding events, heart changes, stroke, embolism, and mortality. The study uses cardiac magnetic resonance imaging to assess clot resolution at three months. Participants will undergo baseline cardiac imaging before randomization and follow regular clinical care visits for treatment and assessment. Researchers will monitor clot volume changes, bleeding events, cardiovascular health, and survival outcomes up to one year. The total study duration for each participant includes treatment and extended follow-up to evaluate safety and effectiveness outcomes in detail.

Apixaban Versus Warfarin for Left Ventricular Thrombus