Evaluation of the Efficacy of Colchicine on Secondary Prevention of Stroke in Patients with Atrial Fibrillation (AF)
Design
Clinical controlled trial, parallel group, double blind, 2 phase, on 100 patients, method of randomisation is block
Settings and conduct
Patients who admitted to Golestan hospital in Ahvaz city with a diagnosis of ischemic stroke for which AF is confirmed will be included in our study. Patients will be random divided into group of active and control and will be treated and followed up for a year for recurrent stroke.
The Drug and placebo will be given to patients in the similar packages by an unaware person. Participation, researchers and health care will be blinded
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients who admitted with ischemic stroke and have atrial fibrillation (AF) at the time of hospitalization. The considered age group is 18 years or older
Exclusion criteria: Allergies and sensitiveness to colchicine, Patients who are taking corticosteroid, Metoteroxate. Patients with inflamatory disease, Patients with severe renal failure or hepatic failure, Patients with moderate to severe cytopenia, Contraindication receiving for rivaroxaban and Pregnant or lactating women and women in childbearing who do not take appropriate contraception
Intervention groups
All patients will be treated with rivaroxaban at the appropriate dose to prevent recurrent stroke. The active group will be additionally treated with colchicine at a dose of 0.5 mg twice daily for a year and the control group will be additionally treated with placebo twice daily for a year too.
Main outcome variables
According to reports on beneficial effects of colchicine as an anti-inflammatory drug, it may be possible to reduce the burden of disability and mortality due to recurrent stroke in high risk pateints
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130311012781N5
Registration date:2020-08-25, 1399/06/04
Registration timing:prospective
Last update:2020-08-25, 1399/06/04
Update count:0
Registration date
2020-08-25, 1399/06/04
Registrant information
Name
ِِDavood Kashipazha
Name of organization / entity
Ahvaz JodndiShapour University of Medical Sciencs
Country
Iran (Islamic Republic of)
Phone
+98 61 1374 3012
Email address
kashi-d@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-21, 1399/04/01
Expected recruitment end date
2020-10-22, 1399/08/01
Actual recruitment start date
2020-09-21, 1399/06/31
Actual recruitment end date
2022-09-22, 1401/06/31
Trial completion date
2022-10-23, 1401/08/01
Scientific title
Evaluation the efficacy of colchicine on secondary prevention of ischemic stroke in patients with atrial fibrillation (AF)
Public title
Effect of Colchicine on secondary prevention of ischemic stroke
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who are admitted with a diagnosis of ischemic stroke and have AF at the time of hospitalization
The considered age group is 18 years or older
Exclusion criteria:
Allergies and sensitivities to colchicine
Patients who are taking corticosteroids, methotrexate, TNFa-blockers, interleukin1 -1b antagonist
Patients with inflammatory disease such as lupus, rheumatoid arthritis, connective tissue disease or chronic infections
Patients with sever Renal failure ( GFR <30 ml/min/1.73 m2) or liver failure (ALT/AST > 2 above normal
Patients with moderate to severe cytopenia (plt < 100000, neutrophil count < 1500) or blood dyscrasia
Patients who are contraindicated for rivaroxaban
Pregnant or lactating women or women in childbearing age who do not take appropriate contraception
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
20
Actual sample size reached:
100
Randomization (investigator's opinion)
Randomized
Randomization description
The method of randomization is bolck in this study. The randomized codes will be produced for 100 patients and then patients will be specified in active and control gruop according to randomization list.
Blinding (investigator's opinion)
Double blinded
Blinding description
participants, principle investigator ، healthcare providers , data collectors ,outcome assessors، data safty and monitoring board and manuscript writers are all blinded in our study.
Patients will be divided into group A and B by a person who is unaware of the patients clinical information by the randomization list. The patients will be treated and followed up according to produced protocol for a year
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committe of ahvaz university of medical sciences
Street address
Esfand Ave., golestan Blvd., Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Approval date
2020-02-24, 1398/12/05
Ethics committee reference number
IR.AJUMS.REC.1398.927
Health conditions studied
1
Description of health condition studied
Ischemic stroke.
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Recurrence of stroke
Timepoint
3, 6, 9 and 12 months after the beginning of study
Method of measurement
Clinical history and imaging finding
Secondary outcomes
empty
Intervention groups
1
Description
All patients will be treated wih the rivaroxaban at the appropriate of dose once daily for a year. Patients will be additionally treated with colchicine at the dose of 0.5 mg twice daily for a year in intervention group. The colchicine tablet will be produced from mofid pharmacy company. Patients will be followed up every three months for a year.
Category
Treatment - Drugs
2
Description
All patients will be treated wih the rivaroxaban at the appropriate of dose once daily for a year. Patients will be additionally treated with placebo twice daily for a year in control group. The placebo tablet will be produced from mofid pharmacy company. Patients will be followed up every three months for a year.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of neurology of golestan hospital
Full name of responsible person
Davood kashipazha
Street address
Farvardin Ave., Golestan Blvd., Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
61357331118
Phone
+98 61 3374 3012
Email
dakashi47@ gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad badavi
Street address
Esfand Ave., Golestan Blvd., Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3336 2414
Fax
+98 61 3336 1544
Email
itc@ajums.ac.ir
Web page address
http://vchresearch.ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Department Research and technology, Ahvaz jundishapur 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
Davood kashipazha
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Farvardin Ave., Golestan Blvd., Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3374 3012
Email
dakashi47@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Davood kashipazha
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Farvardin Ave., Golestan blvd., Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3374 3012
Email
dakashi47@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Davood kashipazha
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Farvardin Ave., Golestan Blvd., Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3374 3012
Email
dakashi47@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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The primary clinical outcome of participants will be shared by the analysis of collected data.
When the data will become available and for how long
6 months after publication of results
To whom data/document is available
available for people who working in academic institutions
Under which criteria data/document could be used
Primary clinical outcome of participants will be shared by tables and charts.
From where data/document is obtainable
Davood kashipazha _ Department of Neurology of Golestan Hospital in Ahvaz.
Email: dakashi47@gmail.com
What processes are involved for a request to access data/document
Please your request will be send by email. our response will be send you by email during a month.