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.
Phase:
Phase 4
Details
Lead Sponsor:
National Institute of Cardiovascular Diseases, Karachi