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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05744804
Enrollment
150
Registered
2023-02-27
Start date
2023-03-01
Completion date
2023-12-01
Last updated
2023-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patient With Anterior Myocardial Infarction

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

Interventions

DRUG-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)

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

Sponsors

Sohag University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Major adverse cardiovascular event10 monthsMajor adverse cardiovascular event
Left ventricular function10 monthsLeft ventricular function
Left ventricular thrombus10 monthsLeft ventricular thrombus
Transient Ischemic Attacks or cerebrovascular stroke10 monthsTransient Ischemic Attacks or cerebrovascular stroke

Countries

Egypt

Contacts

Primary ContactMohamed A Saber, resident
mohamedelameer@med.sohag.edu.eg01150989566
Backup ContactSharaf Eldin S Abdallah, professor
01122789999

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026