Efficacy and safety of Apixaban as treatment for left ventricular thrombus after acute ST-elevation myocardial infarction: a multicentric, randomised, double-blind, double-dummy clinical trial

Abstract

Background: Left ventricular thrombus (LVT) is a frequent complication associated with ventricular dysfunction following ST-segment elevation myocardial infarction (STEMI). It is estimated to have an annual incidence of 200 cases in Catalonia, whose complications can be life-threatening. Nowadays, surprisingly enough given its remarkable morbidity and mortality, there are still many gaps in research regarding the best anticoagulation regimen. With the introduction of direct oral anticoagulants (DOACs) in clinical practice, doubts about the role it could play in the LVT arsenal are increasing. The better convenience and safety of DOACs, such as Apixaban, in certain clinical settings compared to vitamin K anticoagulant antagonists (VKAs), have motivated multiple studies in this regard, such as the present trial. Objective: The main aim of this study is to verify if Apixaban has a non-inferior efficacy compared to the use of Acenocoumarol in the echocardiographic resolution of LVT after STEMI, at the 3-month follow-up. Regarding secondary objectives, we will compare complications and safety between the two groups, as well as identify independent predictors of LVT persistence at 6 months. Design: This study is a multicentric, randomised, controlled, double-blinded, double-dummy, non-inferiority clinical trial