Rivaroxaban vErsus Warfarin for Antithrombotic TheRapy in Patients With LeFt Ventricular Thrombus After Acute STEMI

Study Overview
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Brief Summary
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The purpose of the study is to assess the safety and efficacy of rivaroxaban-based versus warfarin-based antithrombotic regimens on outcomes of patients with left ventricle thrombosis following acute ST elevation myocardial infarction at 3 months from enrollment in an open-label parallel groups pilot randomized clinical trial

Detailed Description
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Direct oral anticoagulants (DOACs), are currently recognized as the first-line treatment of AF and VTE in most clinical scenarios, distinguished by their short half-life, fast onset of action, fewer medication interactions, rare food interactions, and the lack of a need for frequent laboratory monitoring, compared with vitamin K antagonists. Although the use of DOACs has earned a class III recommendation for patients with mechanical prosthetic valves, moderate-to-severe mitral stenosis, and antiphospholipid syndrome, their application in some situations, such as acute limb ischemia and LVT, remains uncertain. Until now, no completed randomized clinical trial has compared the efficacy and safety of left ventricle thrombosis in patients with acute STEMI and the existing evidence is limited to observational studies.

Official Title
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Rivaroxaban vErsus Warfarin for Antithrombotic TheRapy in Patients With LeFt Ventricular Thrombus After Acute ST-Elevation Myocardial Infarction: A Pilot Randomized Clinical Trial

Conditions
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Left Ventricular Thrombus, ST Segment Elevation Myocardial Infarction

Intervention / Treatment
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* Drug: Rivaroxaban 15 MG
* Drug: Warfarin


Participation Criteria
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Eligibility Criteria
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Inclusion criteria Adult patients aged 18-80 years Admission with acute STEMI in past 2 weeks Acute LVT confirmed by non-contrast TTE Willingness to participate and to provide a signed informed consent form Exclusion criteria History of the mechanical prosthetic heart valve, rheumatic heart disease, and confirmed case of antiphospholipid syndrome Active bleeding Cardiogenic shock defined as persistent hypotension (systolic blood pressure <90 mm Hg, or requirement of vasopressor to maintain systolic pressure >90 mm Hg) and clinical signs of hypoperfusion (cold, sweated extremities, oliguria, mental confusion, dizziness, narrow pulse pressure) Acute kidney injury or chronic kidney disease with a glomerular filtration rate <30 ml/min (calculated based on the Cockcroft-Gault formula) Liver failure (Child-Pugh class C) Other indications for chronic anticoagulation (e.g., AF, VTE, etc.) Sensitivity or intolerance to rivaroxaban/warfarin

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: 1:1 open-label parallel group randomized controlled trial with concealed allocation sequence and blinded outcome adjudication
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rivaroxaban-based antithrombotic regimen<br>All patients assigned to the rivaroxaban-based antithrombotic regimen will receive rivaroxaban (15 mg once daily, orally) plus clopidogrel (75 mg daily, orally) plus aspirin (80 mg once daily, orally). Aspirin will be discontinued within 7 days of its initiation. The antithrombotic regimen (i.e., dual therapy) will be continued until three months after randomization. | Drug: Rivaroxaban 15 MG<br>* Rivaroxaban 15 MG once daily orally + Dual anti-platelet therapy (clopidogrel (75 mg daily, orally)+aspirin (80 mg once daily, orally))<br>* Other names: XARELTO;|
| Active Comparator: warfarin-based antithrombotic regimen<br>All patients assigned to the warfarin-based antithrombotic regimen will receive warfarin (overlapping with enoxaparin until reaching an INR goal of 2-2.5) plus clopidogrel (75 mg once daily, orally) plus aspirin (80 mg once daily, orally). Aspirin will be discontinued within 7 days of its initiation. The antithrombotic regimen (i.e., dual therapy) will be continued until three months after randomization. | Drug: Warfarin<br>* Warfarin (to reach an INR goal of 2-2.5)+ Dual anti-platelet therapy (clopidogrel (75 mg daily, orally)+aspirin (80 mg once daily, orally))<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resolution of left ventricular thrombus | Resolution of left ventricular thrombus according to non-contrast 2D TTE performed by the imaging core laboratory, blinded to the allocation assignment | at 3 months from enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Left Ventricle, Ventricle, Left, Thrombosis, Thromboses, Blood Clot, ST Segment Elevation Myocardial Infarction, ST Elevated Myocardial Infarction, STEMI