Safety and Efficacy of Rivaroxaban and Apixaban in Comparison to Warfarin in Left Ventricular Clot- a Clinical Trial

1. TITLE:

Safety and efficacy of Rivaroxaban and Apixaban in comparison to Warfarin in Left ventricular clot- clinical trial 2. INTRODUCTION:

Left ventricular thrombus (LVT) is a known life threatening complication of myocardial systolic dysfunction leading to thromboembolism in about 10-15% cases1. The incidence of LVT has significantly decreased from 40% in pre-reperfusion era to 4% in reperfusion era but still it's a significant number to treat and minimize mortality and morbidities2.3. Up-to-date, guidelines recommended therapy for LVT is warfarin but due to its narrow therapeutic window, drug-drug and drug-food interaction, its use is challenging and cost effective, especially in low to middle income countries as it requires frequent checks on INR (International normalization ratio). In contrast Rivaroxaban has no drug-food or major drug-drug interaction and moreover it doesn't require frequent checks on INR and that's the reason Rivaroxaban use in LVT is gaining traction over time but there is paucity of data both nationally and internationally. Abdelnabi M et al. published the first RCT (randomized control trial, No-LVT trial) on Egyptian population and concluded that rivaroxaban is non inferior to warfarin in LVT but their sample was n=79 out of which rivaroxaban arm had 39 patients only with a power of 80%. Alcalai R et al,4 studied and compared warfarin and Apixaban in LV-thrombus and concluded that Apixaban is non inferior to warfarin in LV-thrombus but their sample size was very low to 17 patients in warfarin and 18 patients in apixaban group. So further studies are required to evaluate the safety and efficacy of rivaroxaban and apixaban in LVT specially in low to middle income countries where LVT management with warfarin is challenging because of narrowed therapeutic window and frequently testing INR. The investigators aimed to design this RCT to compare rivaroxaban and apixaban with warfarin in LVT in terms of safety and efficacy. 3. HYPOTHESIS:

Direct acting oral anticoagulation (rivaroxaban and apixaban) is non inferior to warfarin in LV thrombus resolution

4. MATERIALS AND METHODS: 4a. Study Design: It will be a prospective, randomized, open-label, parallel-group, noninferiority trial to evaluate the efficacy and safety of rivaroxaban and apixaban versus warfarin in the treatment of LVT.