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

Primary Purpose

Patient With Anterior Myocardial Infarction

Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
-group of patients(75 patients) will receive low dose rivaroxaban myocardial infarction plus (acetylsalicylic acid 75 mg and clopidogrel 75 mg
(acetylsalicylic acid 75 mg once daily orally and clopidogrel 75 mg once daily orally only)
Sponsored by
Sohag University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Patient With Anterior Myocardial Infarction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: patients with anterior ST-segment myocardial infarction on acetylsalicylic acid and clopidogrel Exclusion Criteria: Patients with liver cirrhosis. Patients with severe mitral stenosis . Patients with bleeding tendency (HASBLED score ≥ 3) Severe renal impairment ( creatinine clearance < 30 ml/min ). patients with prosthetic valve . patients on ticagrelor treatment patients with Atrial Fibrillation

Sites / Locations

  • Sohag University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

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

control group of patients:

Arm 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

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

Outcomes

Primary Outcome Measures

Major adverse cardiovascular event
Major adverse cardiovascular event
Left ventricular function
Left ventricular function
Left ventricular thrombus
Left ventricular thrombus
Transient Ischemic Attacks or cerebrovascular stroke
Transient Ischemic Attacks or cerebrovascular stroke

Secondary Outcome Measures

Full Information

First Posted
February 16, 2023
Last Updated
February 16, 2023
Sponsor
Sohag University
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1. Study Identification

Unique Protocol Identification Number
NCT05744804
Brief Title
Efficacy and Safety of Low Dose Rivaroxaban in Patients With Anterior Myocardial Infarction
Official Title
Efficacy and Safety of Low Dose Rivaroxaban in Patients With Anterior Myocardial Infarction
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 1, 2023 (Anticipated)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patient With Anterior Myocardial Infarction

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
-group of patients(75 patients) will receive low dose rivaroxaban
Arm Type
Active Comparator
Arm 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
Arm Title
control group of patients:
Arm Type
Active Comparator
Arm Description
control group of patients: 75 Patients of anterior ST-segment myocardial infarction on dual antiplatelet therapy only
Intervention Type
Drug
Intervention Name(s)
-group of patients(75 patients) will receive low dose rivaroxaban myocardial infarction plus (acetylsalicylic acid 75 mg and clopidogrel 75 mg
Intervention Description
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
Intervention Name(s)
(acetylsalicylic acid 75 mg once daily orally and clopidogrel 75 mg once daily orally only)
Intervention Description
control group of patients: 75 Patients of anterior ST-segment myocardial infarction on dual antiplatelet therapy only
Primary Outcome Measure Information:
Title
Major adverse cardiovascular event
Description
Major adverse cardiovascular event
Time Frame
10 months
Title
Left ventricular function
Description
Left ventricular function
Time Frame
10 months
Title
Left ventricular thrombus
Description
Left ventricular thrombus
Time Frame
10 months
Title
Transient Ischemic Attacks or cerebrovascular stroke
Description
Transient Ischemic Attacks or cerebrovascular stroke
Time Frame
10 months

10. Eligibility

Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients with anterior ST-segment myocardial infarction on acetylsalicylic acid and clopidogrel Exclusion Criteria: Patients with liver cirrhosis. Patients with severe mitral stenosis . Patients with bleeding tendency (HASBLED score ≥ 3) Severe renal impairment ( creatinine clearance < 30 ml/min ). patients with prosthetic valve . patients on ticagrelor treatment patients with Atrial Fibrillation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed A Saber, resident
Phone
01150989566
Email
mohamedelameer@med.sohag.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Sharaf Eldin S Abdallah, professor
Phone
01122789999
Facility Information:
Facility Name
Sohag University Hospital
City
Sohag
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Magdy m Amin, professor

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
20805624
Citation
Bhatt DL, Eagle KA, Ohman EM, Hirsch AT, Goto S, Mahoney EM, Wilson PW, Alberts MJ, D'Agostino R, Liau CS, Mas JL, Rother J, Smith SC Jr, Salette G, Contant CF, Massaro JM, Steg PG; REACH Registry Investigators. Comparative determinants of 4-year cardiovascular event rates in stable outpatients at risk of or with atherothrombosis. JAMA. 2010 Sep 22;304(12):1350-7. doi: 10.1001/jama.2010.1322. Epub 2010 Aug 30.
Results Reference
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PubMed Identifier
8026047
Citation
Merlini PA, Bauer KA, Oltrona L, Ardissino D, Cattaneo M, Belli C, Mannucci PM, Rosenberg RD. Persistent activation of coagulation mechanism in unstable angina and myocardial infarction. Circulation. 1994 Jul;90(1):61-8. doi: 10.1161/01.cir.90.1.61.
Results Reference
background
PubMed Identifier
20118566
Citation
Ueda Y, Ogasawara N, Matsuo K, Hirotani S, Kashiwase K, Hirata A, Nishio M, Nemoto T, Wada M, Masumura Y, Kashiyama T, Konishi S, Nakanishi H, Kobayashi Y, Akazawa Y, Kodama K. Acute coronary syndrome: insight from angioscopy. Circ J. 2010 Mar;74(3):411-7. doi: 10.1253/circj.cj-09-0795. Epub 2010 Jan 30.
Results Reference
background
PubMed Identifier
19228706
Citation
Borissoff JI, Spronk HM, Heeneman S, ten Cate H. Is thrombin a key player in the 'coagulation-atherogenesis' maze? Cardiovasc Res. 2009 Jun 1;82(3):392-403. doi: 10.1093/cvr/cvp066. Epub 2009 Feb 19.
Results Reference
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Efficacy and Safety of Low Dose Rivaroxaban in Patients With Anterior Myocardial Infarction

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