Determining and comparing the effectiveness of Rivaroxaban and Warfarin on carotid plaque in non-valvular atrial fibrillation patients
Design
This study is a 2-3 phase clinical trial in wich 60 patients are divided into two groups.People who are visited on the even days receive Rivaroxaban and people who are visited on the odd days receive Warfarin. Patients follow for 6 months . Not blind ,Two arm parallel groups, No control group
Settings and conduct
Sixty patients with non-valvular atrial fibrillation referred to Farabi hospital of Kermanshah in 1397 are randomly divided into two groups. One group will receive Rivaroxaban and one group will receive Warfarin
Participants/Inclusion and exclusion criteria
Non-valvular artrial fibrillation with stroke or transient ischemic attack or IF less than 30%, Lack of kidney and liver diseases and other specific disease, Not taking Aspirin
Intervention groups
One group will receive Rivaroxaban based on GFR and one group will receive Warfarin based on GFR
Main outcome variables
Carotid plaque size, Internal and common carotid stenosis grade, Create new carotid artery plaque, Stroke.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190729044372N1
Registration date:2019-09-01, 1398/06/10
Registration timing:registered_while_recruiting
Last update:2019-09-01, 1398/06/10
Update count:0
Registration date
2019-09-01, 1398/06/10
Registrant information
Name
Leila Afshar hezarkhani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8670 5503
Email address
lafsharh@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-07, 1397/12/16
Expected recruitment end date
2019-09-07, 1398/06/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing efficacy of Rivaroxaban versus Warfarin on carotid plaque in NVAF patients
Public title
Comparing efficacy of Rivaroxaban versus Warfarin on carotid plaque
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Non -valve artrial fibrillation with stroke or TIA or IF<30%
Not taking Asprin
Lack of kidney and liver diseases and other specific disease
Exclusion criteria:
Having a heart valve disorder
Taking Asprin
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
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 Kermanshah University of Medical Sciences
Street address
Kermanshah University of Medical Sciences Building # 2, Shahidbeheshti Ave
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2019-01-08, 1397/10/18
Ethics committee reference number
IR.KUMS.REC.1398.183
Health conditions studied
1
Description of health condition studied
Stroke
ICD-10 code
I67.9
ICD-10 code description
Cerebrovascular disease, unspecified
Primary outcomes
1
Description
Carotid plaque size
Timepoint
Baseline and 6 months later
Method of measurement
Bilateral carotid artery color Doppler ultrasound
2
Description
Internal and common carotid stenosis grade
Timepoint
Baseline and 6 months later
Method of measurement
Bilateral carotid artery color Doppler ultrasound
3
Description
Create new carotid artery plaque
Timepoint
Baseline and 6 months later
Method of measurement
Bilateral carotid artery color Doppler ultrasound
Secondary outcomes
1
Description
Brain stroke
Timepoint
At baseline and 6 Months later
Method of measurement
Bilateral carotid artery color Doppler ultrasound
2
Description
Probability of recurrence of stroke
Timepoint
At baseline and 6 Months later
Method of measurement
Bilateral carotid artery color Doppler ultrasound
Intervention groups
1
Description
Intervention group: In this group, 30 patients are treated with Rivaroxaban based on GFR for 6 months.patients undergo Color Doppler ultrasound At baseline and after 6 months
Category
Treatment - Drugs
2
Description
Intervention group:Thirty patients in this intervention group are treated for 6 months with warfarin made by Obeidi Company based on GFR. patients undergo Color Doppler ultrasound At baseline and after 6 months