Efficacy and Safety of Low Dose Rivaroxaban in Patients With Anterior Myocardial Infarction

Study Overview
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Brief Summary
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Despite the use of guideline directed optimal medical therapy, 12% of patients with stable coronary heart disease and 18% of patients with recent acute coronary syndrome experience recurrent major adverse cardiovascular events 1. The risk of recurrent cardiovascular events may be related to persistent elevation of thrombin beyond the index event 2,3 which leads to progression of cardiovascular disease by inducing inflammation, endothelial dysfunction and thrombosis 4. In patients with coronary heart disease, vitamin K antagonists (VKAs) and direct oral anticoagulants (DOACs) have been explored as secondary prevention strategies and have shown cardiovascular benefits at the cost of higher bleeding events 5,6,7,8. howeverLeft ventricular thrombus (LVT) usually appearswithin 1 month after ST-segment elevation myocardial infarction (STEMI) and mostlyforms after anterior STEMI.9,11Although the prevalenceof LVT after acute myocardial infarction hasdecreased dramatically in modern times due to the progress of reperfusion therapy, LVT incidence in patients with anterior STEMI remains at 4% to 26%.10,12 It complicates acute myocardial infarction and is associated with a higher incidence of poor outcomes.9

Official Title
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Efficacy and Safety of Low Dose Rivaroxaban in Patients With Anterior Myocardial Infarction

Conditions
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Patient With Anterior Myocardial Infarction

Intervention / Treatment
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* Drug: -group of patients(75 patients) will receive low dose rivaroxaban myocardial infarction plus (acetylsalicylic acid 75 mg and clopidogrel 75 mg
* Drug: (acetylsalicylic acid 75 mg once daily orally and clopidogrel 75 mg once daily orally only)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with anterior ST-segment myocardial infarction on acetylsalicylic acid and clopidogrel Exclusion Criteria: Patients with liver cirrhosis. Patients with severe mitral stenosis . Patients with bleeding tendency (HASBLED score ≥ 3) Severe renal impairment ( creatinine clearance < 30 ml/min ). patients with prosthetic valve . patients on ticagrelor treatment patients with Atrial Fibrillation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: -group of patients(75 patients) will receive low dose rivaroxaban<br>-group of patients(75 patients) will receive low dose rivaroxaban (rivaroxaban 2.5 mg twice daily orally) for 1 month after anterior ST-segment myocardial infarction plus dual antiplatelet therapy (acetylsalicylic acid 75 mg once daily orally and cloppe | Drug: -group of patients(75 patients) will receive low dose rivaroxaban myocardial infarction plus (acetylsalicylic acid 75 mg and clopidogrel 75 mg<br>* receive low dose rivaroxaban (rivaroxaban 2.5 mg twice daily orally) for 1 month after anterior ST-segment myocardial infarction plus dual antiplatelet therapy (acetylsalicylic acid 75 mg once daily orally and clopidogrel 75 mg once daily orally)<br>|
| Active Comparator: control group of patients:<br>control group of patients: 75 Patients of anterior ST-segment myocardial infarction on dual antiplatelet therapy only | Drug: (acetylsalicylic acid 75 mg once daily orally and clopidogrel 75 mg once daily orally only)<br>* control group of patients: 75 Patients of anterior ST-segment myocardial infarction on dual antiplatelet therapy only<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse cardiovascular event | Major adverse cardiovascular event | 10 months | 
| Left ventricular function | Left ventricular function | 10 months | 
| Left ventricular thrombus | Left ventricular thrombus | 10 months | 
| Transient Ischemic Attacks or cerebrovascular stroke | Transient Ischemic Attacks or cerebrovascular stroke | 10 months |