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

Not Applicable

Not yet recruiting

• Conditions: Patient With Anterior Myocardial Infarction
• Interventions: 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)

• Registration Number: NCT05744804
• Lead Sponsor: Sohag University

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2023-02
• Study First Submitted: 2023-02-16
• Study First Submitted QC: 2023-02-16
• Last Update Submitted: 2023-02-16
• Study First Posted: 2023-02-27
• Last Update Posted: 2023-02-27
• Study Start: 2023-03-01
• Primary Completion: 2023-12-01
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 150

Inclusion Criteria

• patients with anterior ST-segment myocardial infarction on acetylsalicylic acid and clopidogrel

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Exclusion Criteria

1. Patients with liver cirrhosis.
2. Patients with severe mitral stenosis .
3. Patients with bleeding tendency (HASBLED score ≥ 3)
4. Severe renal impairment ( creatinine clearance < 30 ml/min ).
5. patients with prosthetic valve .
6. patients on ticagrelor treatment
7. patients with Atrial Fibrillation

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
-group of patients(75 patients) will receive low dose rivaroxaban	-group of patients(75 patients) will receive low dose rivaroxaban myocardial infarction plus (acetylsalicylic acid 75 mg and clopidogrel 75 mg	-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
control group of patients:	(acetylsalicylic acid 75 mg once daily orally and clopidogrel 75 mg once daily orally only)	control group of patients: 75 Patients of anterior ST-segment myocardial infarction on dual antiplatelet therapy only

Primary Outcome Measures

Name	Time	Method
Major adverse cardiovascular event	10 months	Major adverse cardiovascular event
Left ventricular thrombus	10 months	Left ventricular thrombus
Transient Ischemic Attacks or cerebrovascular stroke	10 months	Transient Ischemic Attacks or cerebrovascular stroke
Left ventricular function	10 months	Left ventricular function

Trial Locations

Locations (1)

Sohag University Hospital; 🇪🇬 Sohag, Egypt