Rivaroxaban in Left Ventricular Thrombus

Efficacy of Rivaroxaban in Patients With Left Ventricular Thrombus After Acute Myocardial Infarction: An Open Label Randomized Control Trial

The left ventricular (LV) thrombus is an important complication of myocardial infarction (MI) and vitamin K antagonist (VKA) is the current recommended management therapy for these patients. However, lack of regular international normalized ratio (INR) monitoring, drug, and food interaction may leads to increased risk of over or under anticoagulation consequently compromising the effectiveness of the therapy. Hence, due to benefits like predictable dosing and lack of need for regular monitoring, use of non-vitamin K antagonist oral anticoagulants (NOACs) for these patients is increasing among cardiologists. However, clinical data for the justified use of NOACs in LV thrombus (LVT) are lacking and remained a point of debate among the cardiologists. A recently published Randomized Control Trial (RCT) by Abdelnabi M et al. namely the No-LVT trial, had established the safety of Rivaroxaban therapy in patient with post myocardial infarction (MI) LV thrombus along with promising efficacy. However, sample size of the study (n=79; 39 in Rivaroxaban and 40 Warfarin) was not sufficiently high enough to conclude efficacy of Rivaroxaban in these patients. Therefore, this open label RCT is designed with the primary objective to evaluate the efficacy of Rivaroxaban in resolution of post MI LV thrombus as compared to standard warfarin therapy at the interval of 1 month and 3 months to test the hypothesis that Rivaroxaban is safe and non-inferior in preventing thromboembolic and major bleeding events in these patients.

Transthoracic echocardiography assessment for the dissolution of LV thrombus will be blinded to the treatment group

Patients in the control group will receive usual warfarin therapy dose adjusted as per the target INR of 2 to 3

Dose of 20 mg once a day for three months followed by transthoracic echocardiographic assessment for presence/absence of LV thrombus after 4 weeks and 12 weeks

Dose as per the target INR of 2 to 3 with transthoracic echocardiographic assessment for presence/absence of LV thrombus after 4 weeks and 12 weeks

Inclusion Criteria: Patients of acute coronary syndrome with LV thrombus Hemodynamically stable Willing to participate Exclusion Criteria: Prior history of cardiomyopathy Anticoagulant contraindications Prior history of stroke with residual neurological deficit Valvular atrial fibrilation Pregnancy Mentally retarded Deranged liver function tests (LFTS) Creatinine Clearance <50 ml

Abdelnabi M, Saleh Y, Fareed A, Nossikof A, Wang L, Morsi M, Eshak N, Abdelkarim O, Badran H, Almaghraby A. Comparative Study of Oral Anticoagulation in Left Ventricular Thrombi (No-LVT Trial). J Am Coll Cardiol. 2021 Mar 30;77(12):1590-1592. doi: 10.1016/j.jacc.2021.01.049. No abstract available.