Apixaban Versus Warfarin in Patients With Left Ventricular Thrombus

Study Overview
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Brief Summary
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The purpose of this study is to compare the novel oral anticoagulant apixaban with the standard therapy of warfarin on the size reduction or resolution of left ventricular thrombus over 3 months.

Detailed Description
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Current treatment for left ventricular thrombus is anti-coagulant or blood thinning agent known as warfarin. Recently at least three novel oral anticoagulant agents were used in the treatment of atrial fibrillation, pulmonary embolism and deep vein thrombosis (DVT). Novel oral anticoagulant drugs will require no blood taking for INR monitoring, hence less visit and more convenience to patients. Latest studies also showed lesser rate of bleeding as compared to warfarin and hence relatively safer.

Official Title
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Apixaban Versus Warfarin in Patients With Left Ventricular Thrombus: A Prospective Randomized Outcome Blinded Study on the Size Reduction or Resolution of Left Ventricular Thrombus

Conditions
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Left Ventricular Thrombosis

Intervention / Treatment
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* Drug: Apixaban 5 MG Oral Tablet [ELIQUIS]
* Drug: Warfarin Sodium


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 - 80 years old Presence of LV thrombus or spontaneous echo contrast (SEC) grade 3 or 4 (Patel VG 1996), with regional wall motion abnormalities HASBLED score less than 3 No episodes of major bleeding in the past 6 months a) Major bleeding defined as i. episodes of bleeding with significant drop in haemoglobin(Hb)level of at least 2gm/dL - Includes upper and lower gastrointestinal bleed ii. The need for blood transfusion (pack cell) of at least 2 unit iii. Recent surgery with bleeding complications and lost of Hb as in (i) or (ii) iv. Any intracranial bleeds with neurological deficits Exclusion Criteria: Patient with unstable arrhythmias and/or recurrent cardiogenic shock Patient with large ischemic stroke on recruitment-defined as involving >1/3 of cerebral hemisphere or deemed to have high chance of haemorrhagic transformation Patient with permanent pacemaker Patient who is post valve replacement therapy Patient who is pregnant. Patient with advanced kidney disease at stage V and not on dialysis (CrCl <15 mL/min) Patient with advanced liver disease with coagulopathy Patient with organized and old left ventricular thrombus

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Active Comparator: warfarin sodium<br>warfarin daily, dosage according to INR monitor. Aim INR 2-3 | Drug: Warfarin Sodium<br>* as controlled arm since warfarin is the standard therapy for LV thrombus<br>* Other names: Coumadin;|
| Experimental: apixaban<br>Apixaban 5 MG Oral Tablet [ELIQUIS] will be given for randomly selected patients for 3 months. | Drug: Apixaban 5 MG Oral Tablet [ELIQUIS]<br>* Apixaban is licensed for treatment of deep vein thrombosis and pulmonary embolism. Hence, a good study drug for left ventricular thrombosis for possibility of a new indication.<br>* Other names: ELIQUIS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change in Left Ventricular Thrombus (LVT) Size | Percentage of change in left ventricular thrombus (LVT) size after 12 weeks of Warfarin or Apixaban treatment | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Left Ventricular Thrombosis (LVT) by More Than 50% | Percentage of participants who achieved left ventricular thrombus (LVT) reduction more than 50% in both Warfarin and Apixaban arms. | 3 months | 
| Clinically Definite Cardiac Embolic Ischemic Stroke | Number of participants who showed evidence of clinically definite cardiac embolic ischemic stroke (focal neurological deficits persisting for more than 24 hours) confirmed by CT scan | 3 months | 
| Life Threatening Bleeding | Number of participants who experienced life threatening bleeding attributed to the use of anti-coagulation. | 3 months |