RandomizEd compariSOn of apixaban versus warfarin in patients with Left VEntricular thrombus after Acute Myocardial Infarction: RESOLVE-AMI

Background:Left ventricular (LV) thrombus is a serious complication of AMI associated with increased risk of stroke or systemic embolism (SSE).

Warfarin has long been the standard treatment, but the better safety profile of the DOACs makes them an attractive alternative to warfarin.

In the absense of adequately powered randomized studies, no recommendation for the treatment of LV thrombus is provided.Primary Objective: To evaluate the efficacy of apixaban versus warfarin with respect to thrombus resolution Secondary Objectives: To evaluate the safety and efficacy of apixaban versus warfarin with respect to bleeding outcomes, MACE, NACE, stroke and SSE, and the rate of LV thrombus recurrence at one year.

Workplan:Two hundred twelve patients with LV thrombus detected on transthoracic echocardiography (TTE) within 1 to 28 days after an AMI will be randomized 1:1 to apixaban or warfarin. The primary outcome will be evaluated at 3 months. Secondary outcomes as outlined above, will be evaluated at 3 and 12 months.

Significance:It is important to evaluate the use of DOAC (apixaban) for LV thrombus since there are other indications where DOACs were believed to be as effective as warfarin, but randomized trials failed, such as for mechanical heart valves and rheumatic heart disease.

If apixaban prove at least non-inferior to warfarin, apixaban would be the preferred drug due to its better safety profile and convenience. This study will inform LV thrombus treatment recommendations.