Determining the effect of aspirin with and without rivaroxban on symptomatic peripheral vascular disease of the lower extremities of diabetic patients
Design
The clinical trial without blinding; phase 3; randomized according to randomized numbers table with two groups of control (aspirin) and intervention (aspirin + rivaroxaban) on 60 patients, was used for randomization of rand function of Excel software.
Settings and conduct
This study is by randomized control trial and open label. This clinical trial will be performed after the approval of the research plan in the endocrinology clinic of Loghman hospital.
Type 2 diabetic patients with symptomatic peripheral vascular disease of the lower extremities are selected.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Type 2 diabetic patients referred to Loghman Hospital endocrinology clinic (with FBS≥126, two-hour glucose> 180 and hemoglobin a1c> 6.5%) with symptomatic peripheral vascular disease of the lower extremities (with lameness, lower extremity ulcers and nocturnal pain) Are selected.
Exclusion criteria:
: Patients taking Clopidogrel, revascularization treatment, joint disorder and hemoglobin a1c larger and equal to 7.5% are excluded from the study
Intervention groups
After selecting the patients and if they are satisfied to participate in the study, they are randomly divided into 2 groups of aspirin users with and without rivaroxban.
Main outcome variables
Improvement of symptoms and ABI
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220502054720N1
Registration date:2022-10-30, 1401/08/08
Registration timing:retrospective
Last update:2022-10-30, 1401/08/08
Update count:0
Registration date
2022-10-30, 1401/08/08
Registrant information
Name
Mohaddese Abbasi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8827 0723
Email address
mer3de666@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-23, 1400/07/01
Expected recruitment end date
2022-01-20, 1400/10/30
Actual recruitment start date
2021-09-23, 1400/07/01
Actual recruitment end date
2022-01-20, 1400/10/30
Trial completion date
empty
Scientific title
Evaluation the effect of aspirin with and without rivaroxaban in lower extremity symptomatic peripheral artery disease in diabetic patient
Public title
Evaluation the effect of aspirin with and without rivaroxaban in lower extremity symptomatic peripheral artery disease in diabetic patient
Patients who used Clopidogrel,
revascularization treatment,
joint disorder
hemoglobin A1C over and equal to 7.5%
Age
From 30 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done in a simple way for each patient using the website https://www.randomizer.org, which is obtained using random numbers extracted by the software, and the patients will be divided into 2 groups receiving A (Aspirin) and B (Aspirin + Rivaroxaban) are allocated. In other words, we extract random numbers according to the number of samples based on the introduced site, in such a way that even numbers are considered for intervention A and odd numbers are considered for intervention B. Patients are assigned to the corresponding group based on whether they received an odd or even number.
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 Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences, next to Taleghani Hospital, Yemen Street , Shahid Chamran Highway ,Tehran s
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2022-05-16, 1401/02/26
Ethics committee reference number
IR.SBMU.MSP.REC.1401.089
Health conditions studied
1
Description of health condition studied
Type 2 diabetic patients with symptomatic peripheral vascular complications of the lower extremities
ICD-10 code
E11.51
ICD-10 code description
Type 2 diabetes mellitus with diabetic peripheral angiopathy without gangrene
Primary outcomes
1
Description
Claudication
Timepoint
At the beginning of the study and 1 and 3 months after taking aspirin with and without rivaroxaban
Method of measurement
Claudication= Fanton criterion and question from the patient
2
Description
Nocturnal pain
Timepoint
At the beginning of the study and 1 and 3 months after taking aspirin with and without rivaroxaban
Method of measurement
Question from the patient
3
Description
Wound healing
Timepoint
At the beginning of the study and 1 and 3 months after taking aspirin with and without rivaroxaban
Method of measurement
Observation of the facilitator
4
Description
ABI
Timepoint
At the beginning of the study and 1 and 3 months after taking aspirin with and without rivaroxaban
Method of measurement
Ultrasound
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: This group includes 30 patients with type 2 diabetes who have peripheral vascular disease of the lower extremities. Patients in this group will receive aspirin (80 mg daily) and rivaroxaban (5.2 mg every 12 hours).
Category
Treatment - Drugs
2
Description
Control group:This group includes 30 patients with type 2 diabetes who have peripheral vascular disease of the lower extremities. Patients in this group will receive only aspirin (80 mg daily).
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Loghman Hakim hospital
Full name of responsible person
Mohaddese Abbasi
Street address
Loghman Hakim Hospital,Kamali St,South Kargar St.Tehran , Iran
City
Tehran
Province
Tehran
Postal code
1333625445
Phone
+98 21 5102 5182
Fax
+98 21 5541 6130
Email
Lcrdc@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohaddese Abbasi
Street address
Loghman Hakim Hospital,Kamali St,South Kargar St.Tehran , Iran
City
Tehran
Province
Tehran
Postal code
1333625445
Phone
+98 21 5102 5182
Email
mer3de666@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
40
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohaddese Abbasi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
No. 67 , West Aliyali Ave., Gisha., Tehran town
City
Tehran
Province
Tehran
Postal code
1447774415
Phone
+98 21 8827 0723
Fax
Email
mer3de666@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohaddese Abbasi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
No. 67 , West Aliyali Ave., Gisha., Tehran town
City
Tehran
Province
Tehran
Postal code
1447774415
Phone
+98 21 8827 0723
Fax
Email
mer3de666@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohaddese Abbasi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
No. 67 , West Aliyali Ave., Gisha., Tehran town
City
Tehran
Province
Tehran
Postal code
1447774415
Phone
+98 21 8827 0723
Fax
Email
mer3de666@yahoo.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