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Comparing the outcomes of Warfarin consumption compared to Rivaroxaban (Xalerban) in patients with Atrial fibrillation

Protocol summary

Study aim
Comparing the outcomes of Warfarin Consumption Compared to Rivaroxaban (Xalerban) in Patients with Atrial Fibrillation
Design
this phase includes 4, randomized parallel groups clinical trial study. The research units includes 330 individuals. One group will be treated by Warfarin (165) and the other one will be received Rivaroxaban (Xalorban) (165).
Settings and conduct
The research site is Heshmat Hospital in Rasht. Research samples will be followed up by researchers every 15 days in the first month and then every month for 6 month. In this study, a researcher-made checklist will be used to collect demographic data, record liver's enzyme levels, coagulation tests and complications of anticoagulant drugs.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Being over 50 years old, diagnosis of Atrial Fibrillation, CHAD2S2 Vasc score more than 1 exclusion criteria: Patient's dissatisfaction with the study, Wolff Parkinson White Syndrome, allergic to any of the drugs Rivaroxaban (Xalerban) and warfarin, abnormal Creatinine level, and thrombocytopenia.
Intervention groups
In this research, patients are divided to two groups based on random allocation. To prevent atrial fibrillation's complications, patients will be evaluated in two groups of anticoagulant users. A Warfarin-treated group and a Rivaroxaban-treated group (Xalorban). The warfarin group is the control group.
Main outcome variables
Bleeding

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170530034232N2
Registration date: 2019-10-01, 1398/07/09
Registration timing: prospective

Last update: 2019-10-01, 1398/07/09
Update count: 0
Registration date
2019-10-01, 1398/07/09
Registrant information
Name
Jalal Kheirkhah
Name of organization / entity
Healthy Heart Research Center of Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 3366 4282
Email address
kheirkhah@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-22, 1398/07/30
Expected recruitment end date
2021-01-19, 1399/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the outcomes of Warfarin consumption compared to Rivaroxaban (Xalerban) in patients with Atrial fibrillation
Public title
Outcomes of Warfarin and Rivaroxaban (Xalerban) consumption in patients with Atrial fibrillation
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Being over 50 years old Patients with Atrial fibrillation CHAD2S2 Vasc Score more than 1
Exclusion criteria:
Patient's dissatisfaction with the study Wolff Parkinson White Syndrome Allergic to any of the drugs Rivaroxaban (Xalerban) and warfarin Abnormal Creatinine level Thrombocytopenia
Age
From 50 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size: 330
Randomization (investigator's opinion)
Randomized
Randomization description
According to the gradual referral of patients to Dr. Heshmat educational and remedial hospital in Rasht, if they meet the inclusion criteria, randomization is planned to be performed using quadruple-block random allocation method in two groups, group A (Warfarin users) and group B (Xalerban users). According to the sample size, the numbers of these blocks are 83, which were selected by lottery at the beginning of the study, stored in a sealed envelope at Healthy Heart Research Center. After the approval of the research plan and starting the study, the selected blocks will be read out daily by a person who is not involved in the study, according to the patient referrals. Then patients will received the drugs based on block’s permutation.
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 Guilan University of Medical Sciences
Street address
Vice-Chancellor For Research and Technology of Guilan University of Medical Sciences, infront of 17 Shahrivar hospital, Shahid Siadati street, Namjoo street, Rasht
City
Rasht
Province
Guilan
Postal code
41446-66949
Approval date
2019-09-07, 1398/06/16
Ethics committee reference number
IR.GUMS.REC.1398.313

Health conditions studied

1

Description of health condition studied
Atrial fibrillation
ICD-10 code
I48.2
ICD-10 code description
Chronic atrial fibrillation

Primary outcomes

1

Description
Bleeding
Timepoint
All patients will be followed up by researchers every 15 days in the first month and then every month for 6 month.
Method of measurement
Measurement of coagulation factors and hemoglobin level by blood test.

Secondary outcomes

1

Description
Changes in liver's enzymes
Timepoint
All patients will be followed up by researchers every 15 days in the first month and then every month for 6 month.
Method of measurement
Measurement of liver's enzymes (SGOT, SGPT) by blood test.

Intervention groups

1

Description
Intervention group: After random allocation, 165 patients with atrial fibrillation will take one tablet of Rivaroxaban (Xalerban) 20 mg orally, produced by Abidi pharmaceutical company between meal daily for 6 month.
Category
Prevention

2

Description
Control group: After random allocation, 165 patients with atrial fibrillation will take Warfarin produced by Orion corporation pharmaceutical company. The drug dosage will be determined by the physician according to the condition of each patient.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Heshmat heart hospital
Full name of responsible person
Dr. Jalal Kheirkhah
Street address
Heshmat Heart Hospital, Mosalla square, Rasht
City
Rasht
Province
Guilan
Postal code
41939-55588
Phone
+98 13 3366 4282
Email
kheirkhah_jalal@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-Chancellor For Research and Technology of Guilan University of Medical Sciences
Full name of responsible person
Dr. Shadman Nemati
Street address
Vice-Chancellor For Research and Technology, In front of 17 Shahrivar hospital, Shahid Siadati Street, Namjoo Street, Rasht
City
Rasht
Province
Guilan
Postal code
41446-66949
Phone
+98 13 3333 5821
Email
research@gums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-Chancellor For Research and Technology of Guilan University of Medical Sciences
Proportion provided by this source
5
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

2

Sponsor
Name of organization / entity
Dr. Abidi Pharmaceutical Company
Full name of responsible person
Dr. Seyed Amir Razavian Ardahali
Street address
No.72, Abidi square, 8 km Shahid Lashkari highway, Tehran
City
Karaj
Province
Alborz
Postal code
13897-76363
Phone
+98 21 4452 2451
Email
mohammad.mousavi@cobeldarou.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Dr. Abidi Pharmaceutical Company
Proportion provided by this source
95
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other

Person responsible for general inquiries

Contact
Name of organization / entity
Healthy Heart Research Center of Guilan University of Medical Sciences
Full name of responsible person
Dr. Jalal Kheirkhah
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Healthy Heart Research Center, Heshmat Heart Hospital, Mosalla square, Rasht
City
Rasht
Province
Guilan
Postal code
41939-55588
Phone
+98 13 3366 4282
Fax
+98 13 3366 8718
Email
kheirkhah_jalal@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Healthy Heart Research Center of Guilan University of Medical Sciences
Full name of responsible person
Dr. Jalal Kheirkhah
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Healthy Heart Research Center, Heshmat heart hospital, Mosalla square, Rasht
City
Rasht
Province
Guilan
Postal code
41939-55588
Phone
+98 13 3366 4282
Email
kheirkhah_jalal@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Healthy Heart Research Center of Guilan University of Medical Sciences
Full name of responsible person
Dr. Jalal Kheirkhah
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Healthy Heart Research Center, Heshmat Heart Hospital, Mosalla square, Rasht
City
Rasht
Province
Guilan
Postal code
41939-55588
Phone
+98 13 3366 4282
Fax
+98 13 3366 8718
Email
kheirkhah_jalal@yahoo.com
Web page address

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
Undecided - It is not yet known if there will be 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
The SPSS file contains all demographic information (age, sex and body mass index), liver's enzyme information and coagulation tests, and side effects of anticoagulants including: skin complications (ecchymosis and hematoma), gastrointestinal complications (constipation, diarrhea, abdominal pain and nausea). Neurological complications (headache and dizziness), fever, fatigue, edema, pain and muscle spasm, risk of bleeding, TIA and CVA
When the data will become available and for how long
6 month after the results are published, the access period will be start.
To whom data/document is available
Researchers working in academic and scientific institutions.
Under which criteria data/document could be used
To obtain new results, researchers will be permitted to use further analysis and the data in the future researches.
From where data/document is obtainable
Healthy Heart Research Center, Dr Heshmat heart hospital, Mosalla Square, Rasht, Guilan, Iran Phone number: 00981333664282 P.O.Box: 41939-55588
What processes are involved for a request to access data/document
A written request with sufficient detail should be sent to the postal address.After receiving the request, the scientific correspondence author will be responsive within one week.
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