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The effect of low-dose apixaban in the treatment of symptomatic cases of radial artery occlusion following radial artery angiography.

Protocol summary

Study aim
Determining the effect of low-dose apixaban in the treatment of symptomatic cases of radial artery occlusion
Design
In this study, the number of 30 patients (15 in the study group and 15 in the control group) among the people who experienced symptoms such as pain, swelling, and numbness, were evaluated using Doppler waves with a prop Vasculature has been examined and the people who have been confirmed to have radial artery occlusion and who meet the necessary criteria based on the project manager's review to be included in the study, after obtaining informed and written consent, will be included in the study. The control group did not receive treatment. Patients were randomly divided into two groups.
Settings and conduct
This study is a pilot RCT and was conducted in Shahid Chamran Heart Center Hospital, Isfahan, Iran in 1401-1402.
Participants/Inclusion and exclusion criteria
The inclusion criteria are people who have undergone radial artery angiography and then have symptoms related to radial artery occlusion (such as pain and palpable radial pulse). The need for a therapeutic dose of anticoagulants, the use of other anticoagulants, severe symptoms of vascular occlusion that requires rapid intervention to restore the arterial channel, contraindications to the use of apixaban that include severe drug sensitivity, active clinical and pathological bleeding such as gastrointestinal and cerebral, hemostasis disorder and advanced renal failure were considered as exclusion criteria
Intervention groups
The patients in the study group were treated with apixaban (2.5 mg every 12 hours, orally, made by a factory) for 30 days, and after the end of the treatment period, the recovery of the artery was checked again with Doppler waves. to give For people during the study, after the second week, their medication intake will be followed up by phone call.
Main outcome variables
Radial artery occlusion

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20221013056161N1
Registration date: 2023-05-30, 1402/03/09
Registration timing: registered_while_recruiting

Last update: 2023-05-30, 1402/03/09
Update count: 0
Registration date
2023-05-30, 1402/03/09
Registrant information
Name
Amir Seifipour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3629 1716
Email address
amirmed1393@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-22, 1402/03/01
Expected recruitment end date
2023-07-23, 1402/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of low-dose apixaban in the treatment of symptomatic cases of radial artery occlusion following radial artery angiography.
Public title
The effect of low-dose apixaban in the treatment of symptomatic cases of radial artery occlusion following radial artery angiography.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People who have undergone radial artery angiography Symptoms related to radial artery occlusion (such as pain and palpable radial pulse) Confirmed by Doppler imaging
Exclusion criteria:
Lack of patient satisfaction The need for a therapeutic dose of anticoagulants The use of other anticoagulants Severe symptoms of vascular occlusion that require rapid intervention to restore the arterial channel Contraindications for apixaban use include severe drug sensitivity Active clinical and pathological bleeding such as gastrointestinal and cerebral hemostasis disorder and advanced renal failure
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the number of 30 patients (15 in the study group and 15 in the control group) among the people who experienced symptoms such as pain, swelling, and numbness following an angiography through the radial artery, were evaluated using Doppler waves with a prop Vasculature has been examined and the people who have been confirmed to have radial artery occlusion and who meet the necessary criteria based on the project manager's review to be included in the study, after obtaining informed and written consent, will be included in the study.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethical Committee of Isfahan University of Medical Sciences
Street address
Third Mushtaq St. - Salman Farsi St
City
esfahan
Province
Isfehan
Postal code
8158388997
Approval date
2022-07-31, 1401/05/09
Ethics committee reference number
IR.MUI.MED.REC.1401.338

Health conditions studied

1

Description of health condition studied
Radial artery occlusion following angiography
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Radial artery occlusion
Timepoint
Before the intervention and 28 days after the intervention
Method of measurement
The inclusion criteria are people who have undergone radial artery angiography and then have symptoms related to radial artery occlusion (such as pain and palpable radial pulse), which can be confirmed by Doppler imaging. All ultrasounds are performed by a radiologist.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The patients in the study group were treated with apixaban (2.5 mg every 12 hours, orally, manufactured by Abidi Co.) for 28 days, and after the end of the treatment period, the recovery of the artery was again examined with Doppler waves. we put. For people during the study, after the second week, their medication intake will be followed up by phone call
Category
Treatment - Drugs

2

Description
Control group: It included patients with radial artery occlusion after angiography who were selected as the control group and did not receive any anticoagulant treatment.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Chamran Hospital
Full name of responsible person
Dr. Afshin Amirpour
Street address
Third Mushtaq St. Salman Farsi St
City
Esfahan
Province
Isfehan
Postal code
8158388997
Phone
+98 913 107 2678
Email
AfshinAmirpour.Ras@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Asgary
Street address
Third Mushtaq St. Salman Farsi St
City
Isfahan
Province
Isfehan
Postal code
8158388997
Phone
+98 31 3792 8039
Email
askari@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Isfahan Medical School
Proportion provided by this source
10
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
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Afshin Amirpour
Position
Academic staff
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Third Mushtaq St. Salman Farsi St
City
esfahan
Province
Isfehan
Postal code
8158388997
Phone
+98 31 3261 1406
Email
AfshinAmirpour.Ras@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Afshin Amirpour
Position
Academic staff
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Third Mushtaq St. Salman Farsi St
City
esfahan
Province
Isfehan
Postal code
8158388997
Phone
+98 31 3261 1406
Email
AfshinAmirpour.Ras@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Afshin Amirpour
Position
Academic staff
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Third Mushtaq St. Salman Farsi St
City
esfahan
Province
Isfehan
Postal code
8158388997
Phone
+98 31 3261 1406
Email
AfshinAmirpour.Ras@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
Data can potentially be shared after de-identifying individuals
When the data will become available and for how long
"Starting the access period 6 months after printing the results".
To whom data/document is available
It will be available only to researchers working in academic and scientific institutions
Under which criteria data/document could be used
Allowed for the entire documentation
From where data/document is obtainable
Email address
What processes are involved for a request to access data/document
After confirmation by the researcher after one month
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