The goal of this study is to use of rivaroxaban instead of warfarin because of the same effect to reduce the major complication of warfarin in major life threatening bleeding. Although in treatment with rivaroxaban there is not need to routine check for anticoagulant level.
Design
Randomized clinical trial, with parallele group of 60 patients, that treat with warfarin or rivaroxaban
Settings and conduct
The study was done on patients who undergo CABG and coronary endarterectomy in Imam Ali hospital of Kermanshah from 22.11.2018 to 21.3.2019
Participants/Inclusion and exclusion criteria
All patient undergo CABG without prosthetic heart valve and with normal renal function can participate in the study
Intervention groups
Patients who receive warfarin; patients who receive rivaroxaban
Main outcome variables
To substitute rivaroxaban instead of warfarin because of same effect and lesser bleeding complication and easy use for patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181124041746N1
Registration date:2019-01-19, 1397/10/29
Registration timing:registered_while_recruiting
Last update:2019-01-19, 1397/10/29
Update count:0
Registration date
2019-01-19, 1397/10/29
Registrant information
Name
Delnia Rahimpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3837 0252
Email address
dilniya.rahimpour@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-22, 1397/09/01
Expected recruitment end date
2019-03-21, 1398/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assesment and compair the prognosis of warfarin and rivaroxaban in patient with open heart surgery and endarterectomy
Public title
Effect of warfarin and rivaroxaban in coronary endartherectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients undergoing CABG and endarterectomy
Exclusion criteria:
Patients with prosthetic valve
ESRD patents
Age
From 20 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
120
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 Kermanshah University of Medical Sciences
Street address
Shahid Beheshti Blvd., Kermanshah University of Medical Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2018-11-14, 1397/08/23
Ethics committee reference number
IR.KUMS.REC.1397.580
Health conditions studied
1
Description of health condition studied
Coronary arthry disease
ICD-10 code
I25
ICD-10 code description
Atherosclerotic heart disease
2
Description of health condition studied
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Bleeding
Timepoint
3rd day then 3rd month
Method of measurement
Questinannair-interview
2
Description
Cerebrovascular accident
Timepoint
3rd day and 3rd month
Method of measurement
Quastionnair-interview
3
Description
Cardiovascular complcation
Timepoint
3rd day and 3rd month
Method of measurement
Questionnair-interview
4
Description
Thromboembolism
Timepoint
3rd day and3rd month
Method of measurement
Questionnair-interview
Secondary outcomes
empty
Intervention groups
1
Description
In one group, patients recieve warfarin (vitamink antagonist)for 3 monthThe dosage of drug was baced on patients INR. Goal INR was 2-3.we check INR frequently to acheive this goal
Category
Treatment - Drugs
2
Description
In this group patients without chronic kidney diseasd were treated with rivaroxaban(anti xa factor) 15 mg daily for 3month. Dosage of rivaroxaban was fixed and there was not need for check of coagulation state.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Ali hospital of Kermanshah
Full name of responsible person
Delnia Rahimpoor
Street address
Imam Ali hospital, Shahid beheshti Blvd.
City
Kermanshah
Province
Kermanshah
Postal code
6715847145
Phone
+98 83 3836 0041
Email
Dilniya.rahimpour@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Alireza Rai
Street address
Kermanshah University of Medical Sciences, Shahid Beheshti Blvd.
City
Kermanshah
Province
Kermanshah
Postal code
6715847145
Phone
+98 83 3836 0041
Email
Alireza_Rai@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Delnia Rahimpour
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Kermanshah University of Medical Sciences, Shahid Beheshti Blvd.
City
Kermanshah
Province
Kermanshah
Postal code
6715847145
Phone
+98 83 3836 0041
Email
Dilniya.rahimpour@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Delnia Rahimpour
Position
redident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Kermanshah University of Medical Sciences, Shahid Beheshti Blvd.
City
Kermanshah
Province
Kermanshah
Postal code
6715847145
Phone
+98 83 3836 0041
Email
Dilniya.Rahimpour@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Delnia Rahimpour
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Kermanshah University of Medical Sciences, Shahid Beheshti Blvd.
City
Kermanshah
Province
Kermanshah
Postal code
6715847145
Phone
+98 83 3836 0041
Email
Dilniya.Rahimpour@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available