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

February 16, 2023 updated by: Mohamed Elamir Saber, Sohag University

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Sharaf Eldin S Abdallah, professor
  • Phone Number: 01122789999

Study Locations

  • Egypt
      • Sohag, Egypt
        • Sohag University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional 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
-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
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)
Active Comparator: control group of patients:
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)
control group of patients: 75 Patients of anterior ST-segment myocardial infarction on dual antiplatelet therapy only

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2023

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

February 16, 2023

First Submitted That Met QC Criteria

February 16, 2023

First Posted (Estimate)

February 27, 2023

Study Record Updates

Last Update Posted (Estimate)

February 27, 2023

Last Update Submitted That Met QC Criteria

February 16, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • soh-Med-23-01-09

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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