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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-01

Study Completion Date

2023-12-01

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

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Detailed Description

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Conditions

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Patient With Anterior Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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

-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

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

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)

control group of patients:

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

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

Interventions

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

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)

Intervention Type DRUG

(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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No