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Evaluation of the effect of rivaroxaban treatment in comparison with warfarin on the resolution, size, mobility and morphology of left ventricular apical thrombus and also comparing the incidence of bleeding, readmission, embolic events and cardiovascular events in patients with acute coronary syndrome

Protocol summary

Study aim
Evaluation of the effect of rivaroxaban treatment in comparison with warfarin in patients with acute coronary syndrome
Design
Clinical trial with control group with parallel groups, phase 2-3 on 60 patients
Settings and conduct
This study is performed in Chamran Hospital in Isfahan. Patients will be treated with anticoagulants in two ways. The first group receives rivaroxaban tablets and the second group receives warfarin tablets. This study is not blind. After treatment, the characteristics of thrombosis and cardiovascular events in patients will be evaluated and compared 3 months after treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age over 18 years, acute coronary syndrome, treated with aspirin and Plavix Exclusion criteria: renal and hepatic insufficiency, contraindications to anticoagulant therapy, major trauma, uncontrolled hypertension
Intervention groups
Intervention group 1: In this group, patients undergo echocardiography and after the initial anticoagulant treatment, rivaroxaban 15 mg tablets will be used every 12 hours for 21 days and then 20 mg daily. Resolution, size, mobility and morphology of left ventricular apical thrombus as well as comparison of bleeding, readmission, embolic events and major cardiovascular events in patients 3 months after treatment will be evaluated. Intervention group 2: In this group, patients undergo echocardiography and after the initial anticoagulant treatment, warfarin tablets will be used daily to maintain the INR between 2 and 3. Resolution, size, mobility and morphology of left ventricular apical thrombus as well as comparison of bleeding, readmission, embolic events and major cardiovascular events in patients 3 months after treatment will be evaluated.
Main outcome variables
Resolution, size, mobility and morphology of left ventricular apical thrombus

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210614051574N9
Registration date: 2022-02-19, 1400/11/30
Registration timing: prospective

Last update: 2022-02-19, 1400/11/30
Update count: 0
Registration date
2022-02-19, 1400/11/30
Registrant information
Name
Ghasem Mohammadsharifi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3729 4005
Email address
mohammadsharifi.ghasem@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-03, 1400/12/12
Expected recruitment end date
2022-05-02, 1401/02/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of rivaroxaban treatment in comparison with warfarin on the resolution, size, mobility and morphology of left ventricular apical thrombus and also comparing the incidence of bleeding, readmission, embolic events and cardiovascular events in patients with acute coronary syndrome
Public title
Treatment with rivaroxaban compared with warfarin in patients with acute coronary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years Acute coronary syndrome Treated with aspirin and Plavix
Exclusion criteria:
Renal and hepatic failure Existence of contraindications to anticoagulant therapy Major trauma Uncontrolled hypertension
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Esfahan University of Medical Sciences
Street address
Esfahan University of Medical Sciences, Hezar Jarib Ave., Esfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2020-11-10, 1399/08/20
Ethics committee reference number
IR.MUI.MED.REC.1399.710

Health conditions studied

1

Description of health condition studied
Acute coronary syndrome
ICD-10 code
I24
ICD-10 code description
Other acute ischemic heart diseases

Primary outcomes

1

Description
Left ventricular morphology information
Timepoint
3 months after starting the study
Method of measurement
Eco cardiography

2

Description
Bleeding
Timepoint
3 months after starting the study
Method of measurement
Review the case and follow up with the patient

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: In this group, patients undergo echocardiography and after the initial anticoagulant treatment, rivaroxaban 15 mg tablets from Abureyhan Company will be used every 12 hours for 21 days and then 20 mg daily. Resolution, size, mobility and morphology of left ventricular apical thrombus by echocardiography as well as comparison of bleeding, readmission, embolic events and major cardiovascular events in patients 3 months after treatment will be evaluated.
Category
Treatment - Drugs

2

Description
Intervention group 2: In this group, patients undergo echocardiography and after the initial anticoagulant treatment, 5 mg warfarin tablets from Abureyhan Company will be used daily to maintain the INR between 2 and 3. Resolution, size, mobility and morphology of left ventricular apical thrombus by echocardiography as well as comparison of bleeding, readmission, embolic events and major cardiovascular events in patients 3 months after treatment will be evaluated.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Chamran hospital
Full name of responsible person
Mohmmad Hadi Mansouri
Street address
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0042
Email
parsa.alinezhad85@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo
Street address
Isfahan University of Medical Sciences, Hezar Jarib Ave,. Daneshgah Blvd, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673118
Phone
+98 31 3668 0048
Email
haghjoo.sh@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Hadi Mansouri
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0042
Email
parsa.alinezhad85@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Hadi Mansouri
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0042
Email
parsa.alinezhad85@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Hadi Mansouri
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0042
Email
parsa.alinezhad85@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data can be shared after people have requested.
When the data will become available and for how long
Six months after publishing the results.
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
Scientific uses
From where data/document is obtainable
Website of the Research Committee of Isfahan University of Medical Sciences
What processes are involved for a request to access data/document
Clear request on the site to access the data by the individual and then review the request by the research assistant within 2 weeks and then allow access to the data.
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