Apixaban in Patients With Left Ventricular Thrombus

Study Overview
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Brief Summary
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Open label randomized controlled clinical trial to evaluate the efficacy and safety of apixaban versus warfarin in treating left ventricular thrombus in patients with acute or recent myocardial infarction (MI).

Official Title
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Apixaban in Patients With Left Ventricular Thrombus Post Myocardial Infarction; A Randomized Clinical Trial

Conditions
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Left Ventricular Thrombus

Intervention / Treatment
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* Drug: Apixaban
* Drug: Warfarin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All the following criteria must be fulfilled: Ages between 18 and 80 years, History of anterior wall MI, either acute (within a week) or recent (within a month) Evident left ventricular thrombus (LVT) by transthoracic echocardiography, Naïve to oral anticoagulants (OAC) stable to start OAC Exclusion Criteria: Other indications for OAC, Patients with contraindications for OAC, Right ventricular thrombus or atrial thrombus, History of confirmed stroke or other systemic embolization within the previous six months, High bleeding risk, Severe renal impairment, Patients with expected difficulties to follow the INR strictly.

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
Interventional Model Description: Open label randomized controlled clinical trial, two parallel active groups, with blinded primary study outcome assessor.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Apixaban<br>Apixaban, 5 mg oral tablets, on top of updated guidelines of acute coronary syndrome management recommendations | Drug: Apixaban<br>* 5 mg twice daily, on top of standards of care.<br>* Other names: Eliquis;|
| Active Comparator: Warfarin<br>Warfarin, oral tablets, to achieve international normalized ratio (INR) of 2-3, on top of standards of care, as per updated guidelines of acute coronary syndrome management recommendations | Drug: Warfarin<br>* Warfarin, oral tablets, to achieve international normalized ratio (INR) of 2-3, on top of standards of care, as per updated guidelines of acue coronary syndrome management recommendations<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resolution of left ventricular thrombus | Transthoracic, noncontrast, echocardiographic assessment. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resolution of left ventricular thrombus | Transthoracic, noncontrast, echocardiographic assessment. | 6 months | 
| Safety outcome | Major Adverse Cardiovascular Events (MACE) or any relevant bleeding according to the Bleeding Academic Research Consortium (BARC) classification | 3-6 months |