Evaluation of the effectiveness of with different types of anticoagulants treatment in patients with atrial fibrillation in one-year follow-up in preventing stroke and bleeding complications comparison of drugs warfarin rivaroxaban and apixaban
Evaluation of the effectiveness of with different types of anticoagulants treatment in patients with atrial fibrillation in one-year follow-up in preventing stroke and bleeding complications
Identifying the best treatment option among available anticoagulants to prevent stroke and bleeding events in patients with atrial fibrillation
Design
Clinical trial, parallel group trial with blinded, randomised outcome assessment, a phase 2 trial on 198 patients
Settings and conduct
The aim of the present study was to evaluate the effectiveness of one-year anticoagulants (rivaroxaban, apixaban and warfarin) for preventing stroke and bleeding complications in atrial fibrillation patients referred to Imam Khomeini Hospital in Ahvaz. Therapeutic effectiveness is measured by clinical examinations, coagulation tests, haemoglobin nad platelet count. This double blind clinical trial is based on the protocol in in which neither the participants nor the data analyzer knows which treatment or intervention participants are receiving until the clinical trial is over.
Participants/Inclusion and exclusion criteria
Exclusion criteria:
1-Patients treated with multiple oral anticoagulants
2-Taking multiple doses of the drug
3-Taking drugs with indications other than prevention of stroke and hemorrhage
4-Loss to follow-up before 1 year
5-Patients without comorbidity known to be associated with higher mortality, such as heart failure, cancer, chronic pulmonary disease
Inclusion criteria:
1-Age > 18 years
2-Diagnosis of atrial fibrillation
3-Informed consent to participate in the study
4-Elevated CHA2DS2-VASc score of 2 or greater in men or 3 or greater in women
Minor and major bleeding; Ischemic stroke; Systemic embolism
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220404054402N1
Registration date:2022-06-10, 1401/03/20
Registration timing:prospective
Last update:2022-06-10, 1401/03/20
Update count:0
Registration date
2022-06-10, 1401/03/20
Registrant information
Name
zahra khademi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3222 8037
Email address
zahrakhademi157@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-21, 1401/03/31
Expected recruitment end date
2022-09-09, 1401/06/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of with different types of anticoagulants treatment in patients with atrial fibrillation in one-year follow-up in preventing stroke and bleeding complications comparison of drugs warfarin rivaroxaban and apixaban
Public title
Evaluation of the effectiveness of with different types of anticoagulants treatment in patients with atrial fibrillation in one-year follow-up in preventing stroke and bleeding complications
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age > 18 years
Diagnosis of atrial fibrillation
Informed consent to participate in the study
Elevated CHA2DS2-VASc score of 2 or greater in men or 3 or greater in women
Exclusion criteria:
Patients treated with multiple oral anticoagulants
Taking multiple doses of the drug
Taking drugs with indications other than prevention of stroke and hemorrhage
Loss to follow-up before 1 year
Patients without comorbidity known to be associated with higher mortality such as heart failure, cancer, chronic pulmonary disease
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
198
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be performed using block randomization of 3 blocks in 3 groups including group A (Rivaroxaban), group B (Apixaban) and group C (Warfarin). According to the sample size, the number of these blocks is 66 (198/3). The block randomization are done by random number table at the beginning of the study and stored in a sealed envelope. After the research approval, the blocks will be taken out daily based on the patients' referrals through a person who is not in the study. Patients receive the desired drugs based on block permutation.
Blinding (investigator's opinion)
Double blinded
Blinding description
This is a double-blind randomized clinical trial in which neither the data analyst nor the person who is evaluating the outcomes knows which type of drugs patients are receiving until the end of the study .
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Golestan hospital
Street address
Farvardin Ave ., Ahvaz ., Iran
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2022-02-01, 1400/11/12
Ethics committee reference number
IR.AJUMS.HGOLESTAN.REC.1400.174
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
Minor and major bleeding
Timepoint
First after 6 months after 12 months
Method of measurement
Physical exam,Hemoglobin,Pletlet and Coagulation test
2
Description
Ischemic stroke and Systemic embolism
Timepoint
First after 6 months after 12 months
Method of measurement
Physical exam
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 15-20 mg oral rivaroxaban once daily for 1 year (Arena Hayat Danesh company)
Category
Prevention
2
Description
Intervention group: 2.5-5 mg oral apixaban twice daily for 1 year (Arena Hayat Danesh company)
Category
Prevention
3
Description
Intervention group: 5 mg oral warfarin once daily for 1 year (Dr.Abidi pharmaceutical company)
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini hospital
Full name of responsible person
Zahra Khademi
Street address
Azadegan Ave., Ahvaz ., Iran
City
Ahvaz
Province
Khouzestan
Postal code
6193673166
Phone
+98 61 3222 2922
Email
himam@ajums.ac.ir
2
Recruitment center
Name of recruitment center
Golestan hospital
Full name of responsible person
Zahra Khademi
Street address
Farvardin Ave ., Ahvaz ., Iran
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3320 4501
Email
golestanjpspital@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr.Mehrnoosh Zakerkish
Street address
Esfand Ave., Golestan Blvd ., Ahvaz., Iran
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3333 3477
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
Zahra Khademi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Esfand Ave., Golestan Blvd ., Ahvaz., Iran
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3333 3477
Email
zahrakhademi157@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Zahra Khademi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Esfand Ave., Golestan Blvd ., Ahvaz., Iran
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3333 3477
Email
zahrakhademi157@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Zahra Khademi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
Esfand Ave., Golestan Blvd ., Ahvaz., Iran
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3333 3477
Email
zahrakhademi157@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
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