Assessment of the impact of Rivaroxaban in patients with peripheral artery disease (PAD) of the lower extremities who underwent endovascular revascularization to prevent major organ and cardiovascular side effects
Assessment of the impact of Rivaroxaban in patients with peripheral artery disease (PAD) of the lower extremities who underwent endovascular revascularization
Design
A controlled trial , parallel-group, single-blind, randomized;
phase 4 clinical trial on 122 patients with a 6-month follow-up.
Settings and conduct
Medication intervention will be done in symptomatic patients with lower limb peripheral vessels who underwent endovascular revascularization surgery. The patients will be referred to Imam Ahvaz Hospital and the duration of the study is 6 months. Two intervention and control groups will receive medications for 6 months.Patients will be followed up one week, one month, three months and six months after starting the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria; Patients with peripheral artery disease (PAD) of the lower extremities who underwent endovascular revascularization; age above 50, Patients who have clinical need for systemic anticoagulation will not be included in the study.
Intervention groups
The intervention and control groups will receive medication. Patients in the intervention group will receive 2.5 mg Rivaroxaban tablet twice daily plus Aspirin once daily for 6 months, and the control group will receive 2.5 mg Plavix tablet twice a day plus Aspirin once a day for 6 months.
Main outcome variables
Status of wound, limb preservation, lameness, and pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231117060086N1
Registration date:2023-11-26, 1402/09/05
Registration timing:prospective
Last update:2023-11-26, 1402/09/05
Update count:0
Registration date
2023-11-26, 1402/09/05
Registrant information
Name
Arman Azmoon
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3292 3985
Email address
dr.arman.azmoon2020@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-22, 1402/10/01
Expected recruitment end date
2024-07-22, 1403/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of the impact of Rivaroxaban in patients with peripheral artery disease (PAD) of the lower extremities who underwent endovascular revascularization to prevent major organ and cardiovascular side effects
Public title
Assessment of the impact of Rivaroxaban in peripheral artery disease (PAD) of the lower extremities
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with peripheral artery disease (PAD) of the lower extremities who underwent endovascular revascularization
Age above 50 years
Exclusion criteria:
Clinical need for systemic anticoagulation
Age
From 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
Investigator
Sample size
Target sample size:
112
Randomization (investigator's opinion)
Randomized
Randomization description
To create a simple random sequence, two-group web-based randomization (www.graphpad.com) and to hide the random allocation, the method of packet envelopes with random sequence (SNOSE) will be used, several envelopes, preparation, and each of the sequences. The created coincidences are recorded on a card and the cards are placed in the letter envelopes in order. To preserve the random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lid of the letter envelopes is glued and placed inside the boxes in order, at the time of the registration of the participants, according to the order of entry of the eligible participants into the study, one of the letter envelopes is opened in order and the assigned group of that participant, it is revealed
Blinding (investigator's opinion)
Single blinded
Blinding description
It will be a single-blinded study. The researcher will be blinded about the type of medications, but the patients will be informed. To hide the drugs, they will be placed in a sealed, numbered envelope. The preparation of the envelopes will be done by a person, who will not be involved in the research.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz َJundishapur University of Medical Sciences
Street address
Golestan St. Jundishapur University of medical sciences
City
اهواز
Province
Khouzestan
Postal code
61357-15794
Approval date
2022-04-19, 1401/01/30
Ethics committee reference number
IR.AJUMS.HGOLESTAN.REC.1401.031
Health conditions studied
1
Description of health condition studied
Peripheral artery disease (PAD) of the lower extremities
ICD-10 code
I73.9
ICD-10 code description
Peripheral vascular disease, unspecified
Primary outcomes
1
Description
Status of Pain and lameness
Timepoint
Patients will be followed up for a visit one week, one month, three months and six months after starting the medication
Method of measurement
Clinical examination
Secondary outcomes
1
Description
Status of heart attack, ischemic stroke, cardiovascular death, acute limb ischemia and limb amputation due to vascular causes
Timepoint
Patients will be followed up for a visit one week, one month, three months and six months after starting the intervention.
Method of measurement
Clinical examination
Intervention groups
1
Description
Intervention group; patients will receive 2.5 mg of Rivaroxaban tablet brand name (Axabin, Iran Hormon, Iran) twice a day plus َ100 mg Aspirin tablet (A.S.A, Loghman Pharma, Iran) once a day for 6 months.
Category
Treatment - Drugs
2
Description
Control group: patients will receive 2.5 mg Plavix tablet Brand name (Clopidogrel, Kobel Daru, Iran) twice a day plus َ100 mg Aspirin (A.S.A, Loghman Pharma, Iran) once a day, for 6 months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Hospital in Ahvaz
Full name of responsible person
Arman Azmoon
Street address
Azadegan St
City
Ahvaz
Province
Khouzestan
Postal code
6193673111
Phone
+98 61 3222 7534
Email
dr.arman.azmoon2020@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Seyed Masoud Mousavi
Street address
Azadegan St, Ahvazian Ave, Emam Hospital
City
Ahvaz
Province
Khouzestan
Postal code
6193673111
Phone
+98 61 3222 7534
Email
musavi-m@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
Arman Azmoon
Position
Surgeon
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Azadegan St, Ahvazian Ave, Emam Hospital
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3292 3985
Email
dr.arman.azmoon2020@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Arman Azmoon
Position
Surgeon
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Azadegan St, Ahvazian Ave, Emam Hospital
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3292 3985
Email
dr.arman.azmoon2020@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Arman Azmoon
Position
Surgeon
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Azadegan St, Ahvazian Ave, Emam Hospital
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3292 3985
Email
dr.arman.azmoon2020@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
All data can be shared after anonymising the patients.
When the data will become available and for how long
Access period will start after publishing the results.
To whom data/document is available
Every body
Under which criteria data/document could be used
There is no barrier to access.
From where data/document is obtainable
Dr. Arman Amoon
Email:dr.arman.azmoon2020@gmail.com
What processes are involved for a request to access data/document
Requesters can be informed of the final results by sending an email to the researcher and receiving a response within a week.