Rivaroxaban in Left Ventricular Thrombus

Study Overview
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Brief Summary
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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.

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

Conditions
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Acute Coronary Syndrome, Left Ventricular Thrombus

Intervention / Treatment
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* Drug: Rivaroxaban
* Drug: Warfarin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>Patients in the intervention group will receive Rivaroxaban 20 mg once a day (OD) for three months | Drug: Rivaroxaban<br>* 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<br>|
| Active Comparator: Control group<br>Patients in the control group will receive usual warfarin therapy dose adjusted as per the target INR of 2 to 3 | Drug: Warfarin<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left ventricular (LV) thrombus | Presence or absence of LV thrombus on transthoracic echocardiographic | After 12 weeks of randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stroke or systemic embolism | Confirmed on computerized tomography (CT) scan | Within 12 weeks of randomization | 
| Major bleeding | As per the International Society on Thrombosis and Haemostasis (ISTH) criteria | Within 12 weeks of randomization |