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

Sohag University

Status: Not yet enrolling

Conditions: Patient With Anterior Myocardial Infarction

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05744804

soh-Med-23-01-09

Details and patient eligibility

About

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

Enrollment: 150 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

-group of patients(75 patients) will receive low dose rivaroxaban

Active Comparator group

Description:

-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

Treatment:

Drug: -group of patients(75 patients) will receive low dose rivaroxaban myocardial infarction plus (acetylsalicylic acid 75 mg and clopidogrel 75 mg

control group of patients:

Active Comparator group

Description:

control group of patients: 75 Patients of anterior ST-segment myocardial infarction on dual antiplatelet therapy only

Treatment:

Drug: (acetylsalicylic acid 75 mg once daily orally and clopidogrel 75 mg once daily orally only)