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Evaluating the clinical efficacy of Apixaban vs. Warfarin in patients with cerebral venous thrombosis (CVT)

Protocol summary

Study aim
Comparison of clinical effectiveness and side effects of apixaban compared to warfarin in patients with cerebral venous thrombosis (CVT).
Design
Clinical trial with a control group, with parallel groups, unblinded, randomized, phase 4 on 74 patients. The rand function of Excel software was used for randomization
Settings and conduct
A randomized controlled study was conducted to evaluate the clinical effectiveness and side effects of apixaban in comparison with warfarin among patients with CVT referred to Ahvaz Golestan Hospital, after approval by the Research Council of Ahvaz Jundishapur University of Medical Sciences and receiving the code of medical ethics from the relevant research assistant. will be. All eligible people are included in the study according to the entry criteria after obtaining informed and written consent. Also, the provisions of the Helsinki research ethics statement and the principles of confidentiality of patient information will be observed. The study continues from the time of approval of the plan until the desired sample size is reached
Participants/Inclusion and exclusion criteria
All patients over 18 years of age who are diagnosed with CVT by MR venography or CT venography. People with severe liver and kidney disorder, mental disorder, impaired consciousness or inability to swallow oral medications, central nervous system or trauma Severe headache, patients who have undergone brain surgery and patients with brain tumor are excluded from the study
Intervention groups
Patients are divided into two groups, apixaban and warfarin, and their clinical efficacy and side effects are compared
Main outcome variables
Age, gender, BMI, risk factors, clinical status of the patient, type of treatment, frequent thrombosis or major bleeding

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240217061039N1
Registration date: 2024-05-16, 1403/02/27
Registration timing: registered_while_recruiting

Last update: 2024-05-16, 1403/02/27
Update count: 0
Registration date
2024-05-16, 1403/02/27
Registrant information
Name
Afarin Ahmadian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3374 3001
Email address
frn.ahmadian@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-09, 1403/01/21
Expected recruitment end date
2024-10-12, 1403/07/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the clinical efficacy of Apixaban vs. Warfarin in patients with cerebral venous thrombosis (CVT)
Public title
Evaluating the clinical efficacy of Apixaban vs. Warfarin in patients with cerebral venous thrombosis (CVT)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients over 18 years of age who are diagnosed with CVT in imaging
Exclusion criteria:
Age
From 18 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size: 74
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the Block Randomization method will be used to assign each participant to intervention groups using a block size of four. Excel software and rand() function are used to prepare random sequences inside each block. After determining the type of intervention in each participant, a non-repeating four-digit code is assigned to the individual. The codes assigned through a software are assigned to the qualified candidates respectively.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of ahvaz Jondi Shapour university of medical sciences
Street address
Golestan Blvd ,west saheli Blvd,kooye ostadan
City
Ahvaz
Province
Khouzestan
Postal code
۶۱۳۵۷-۱۵۷۹۴
Approval date
2024-01-09, 1402/10/19
Ethics committee reference number
IR.AJUMS.REC.1402.521

Health conditions studied

1

Description of health condition studied
Cerebral venous thrombosis
ICD-10 code
I63.6
ICD-10 code description
Cerebral infarction due to cerebral venous thrombosis, nonpyogenic

Primary outcomes

1

Description
Evaluating the clinical efficacy of Apixaban vs. Warfarin in patients with cerebral venous thrombosis
Timepoint
6 months
Method of measurement
Clinical efficacy is measured by calculating the 6-months MRS and the rate of recanalization. Drug side effects are also studied by examining the rate of major bleeding and recurrence of thrombosis.

Secondary outcomes

1

Description
Comparison of the relationship between 6-months MRS-recanalization-the rate of recurrence of thrombosis and major bleeding with age-sex and each of the risk factors between two drug groups
Timepoint
6 months
Method of measurement
The relationship of each case of 6-months MRS- recanalization- recurrence of thrombosis and major bleeding with age- sex and each of the risk factors between the two drug groups of apixaban and warfarin is measured.

Intervention groups

1

Description
Intervention group: Intervention group: Standard treatment is given by injecting intravenous heparin or sub-cutaneous enoxaparin (at a dose of 1 mg per kg) twice a day for 5-10 days. After stopping intravenous heparin, oral apixaban at a dose of 5 mg twice It is given per day.
Category
Treatment - Drugs

2

Description
Control group:standard treatment is given by injecting intravenous heparin or subcutaneous enoxaparin (at a dose of 1 mg per kg) twice a day for 5-10 days. Warfarin will not be used in the acute phase.warfarin and heparin (or enoxaparin) is given as a combination for 3-5 days, and then when the INR reaches 2-3, heparin will be stopped and warfarin will continue for at least 12 weeks.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Golestan hospital of Ahvaz
Full name of responsible person
Afarin Ahmadian
Street address
Golestan hospital ,kooye golestan
City
Ahvaz
Province
Khouzestan
Postal code
۶۴۴۱۹۴۵۷۸۱
Phone
+98 61 3337 4058
Email
golestanhospital@ajums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Vice President of Research and Technology Development
Street address
Jundishapur University of Medical Sciences, Esfand Ave, Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3311 4153
Email
info@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Afarin Ahmadian
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
Golestan Hospital, Farvardin Blvd, Golestan
City
Ahwaz
Province
Khouzestan
Postal code
۶۴۴۱۹۴۵۷۸۱
Phone
+98 61 3374 3001
Fax
Email
frn.ahmadian@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Afarin Ahmadian
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
Golestan Hospital, Farvardin Blvd, Golestan
City
Ahwaz
Province
Khouzestan
Postal code
۶۴۴۱۹۴۵۷۸۱
Phone
+98 61 3374 3001
Fax
Email
frn.ahmadian@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Afarin Ahmadian
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
Golestan Hospital, Farvardin Blvd, Golestan
City
Ahwaz
Province
Khouzestan
Postal code
۶۴۴۱۹۴۵۷۸۱
Phone
+98 61 3374 3001
Fax
Email
frn.ahmadian@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
The information related to the main outcome in the data of the participants after deidentifying the individuals, the study protocol, the statistical analysis plan, the informed consent form, the clinical study report, the codes used in the analysis and the data classification system can be shared.
When the data will become available and for how long
The access period starts six months after the publication of the results
To whom data/document is available
All doctors and researchers working in academic and scientific institutions
Under which criteria data/document could be used
Using data and documentation to conduct similar and additional research and studies
From where data/document is obtainable
The email of the person responsible for scientific and general accountability Frn.ahmadian@gmail.com Afarin ahmadian
What processes are involved for a request to access data/document
The email of the person responsible for scientific and general accountability Frn.ahmadian@gmail.com Well done Ahmadiyan
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