To assess the effect of rivaroxaban versus apixaban on treatment of cerebral venous thrombosis
Design
This is a randomized clinical trial with control group, phase III, in which eligible patients will be randomly assigned through the block randomization to the intervention and control groups
Settings and conduct
This study will be performed in the Besat Hospital in Hamadan city on 32 eligible patients. The patients will be randomly assigned to the intervention and control groups through the block randomization. This study will be performed without blinding.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age 18 to 80 years
Cerebral venous thrombosis
Exclusion criteria:
Contraindication o anticoagulant therapy
Brain tumor
Intervention groups
Intervention group:
Rivaroxaban tablets 15 mg twice a day for 3 weeks and then 20 mg daily for 6 months
Control group:
Apixaban tablets 10 mg twice a day for 3 weeks and then 5 mg twice a day for 6 months
Main outcome variables
Primary outcome:
Functional impairment
Secondary outcome:
Complication of cerebral hemorrhage
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N451
Registration date:2022-12-24, 1401/10/03
Registration timing:registered_while_recruiting
Last update:2022-12-24, 1401/10/03
Update count:0
Registration date
2022-12-24, 1401/10/03
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-22, 1401/10/01
Expected recruitment end date
2023-09-22, 1402/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of rivaroxaban versus apixaban on treatment of cerebral venous thrombosis: a randomized clinical trial
Public title
Effect of rivaroxaban versus apixaban on treatment of cerebral venous thrombosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 80 years
Cerebral venous thrombosis
Exclusion criteria:
Contraindication o anticoagulant therapy
Brain tumor
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare four sheets of paper, writing on two sheets the name of the intervention and on the other two sheets the name of the control. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all four sheets are drawn. The four paper sheets will be then placed back into the container, and this action repeated until the sample size is reached.
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 Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2022-06-27, 1401/04/06
Ethics committee reference number
IR.UMSHA.REC.1401.321
Health conditions studied
1
Description of health condition studied
Cerebral venous thrombosis
ICD-10 code
I63.00
ICD-10 code description
Cerebral infarction due to thrombosis of unspecified precerebral artery
Primary outcomes
1
Description
Functional impairment
Timepoint
90 days after intervention
Method of measurement
Using modified Rankin Scale (mRS)
Secondary outcomes
1
Description
Complication of cerebral hemorrhage
Timepoint
During the 6-month follow-up period
Method of measurement
Using brain CT scan
Intervention groups
1
Description
Intervention group: Rivaroxaban tablets 15 mg twice a day for 3 weeks and then 20 mg daily for 6 months
Category
Treatment - Drugs
2
Description
Control group: Apixaban tablets 10 mg twice a day for 3 weeks and then 5 mg twice a day for 6 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital in Hamadan city
Full name of responsible person
Dr Maryam Ghasemi
Street address
Besat Hospital, Shahed Square
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3364 0030
Email
maryam.gh1989@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Reza Shokoohi
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Dr Maryam Ghasemi
Position
Resident of Neurology
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
maryam.gh1989@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Mojtaba Khazaei
Position
Neurologist
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
khazaeimojtaba@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available