Impact of Cilostazol on results of Balloon Angioplasty for Infrapopliteal Artery Disease in Patients with Lower Limb Ischemia admitted to Ahwaz Golestan hospital vascular surgery ward
Impact of Cilostazol on improvement of ischemic symptoms after infrapopliteal angioplasty in patients with lower exteremity ischemia
Design
Two arm parallel group randomized clinical trial
Settings and conduct
All patients with lower exterimity ischemia and indication of infrapopliteal angioplasty that admitted to Ahvaz Golestan hospital vascular surgery ward randomized in two case and control groups and after successful angioplasty case group will treat with Cilostazol plus Plavix and control group will treat with Plavix and after 3 months results will be assessed.
Participants/Inclusion and exclusion criteria
Inclusion criteria are patients with lower exteremity ischemic symptoms and age greater than 40 years old and exclusion criteria are previous lower exterimity endovascular therpy, previous lower exterimity bypass surgery and patients with congestive heart failure.
Intervention groups
After successful infrapopliteal angioplasty one group of patients will treat with cilostazol plus Plavix and another group will treat with Plavix .
Main outcome variables
Relief of ischemic symptoms ( based on Rutherford classification ); Ischemic ulcer healing; need for limb amputation; need for repeat endovascular therapy; need for open surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190418043306N1
Registration date:2019-06-11, 1398/03/21
Registration timing:retrospective
Last update:2019-06-11, 1398/03/21
Update count:0
Registration date
2019-06-11, 1398/03/21
Registrant information
Name
Navid Salimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3338 7435
Email address
rebellious.surgeon@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-21, 1397/01/01
Expected recruitment end date
2019-01-21, 1397/11/01
Actual recruitment start date
2018-03-21, 1397/01/01
Actual recruitment end date
2019-01-21, 1397/11/01
Trial completion date
2019-01-21, 1397/11/01
Scientific title
Impact of Cilostazol on results of Balloon Angioplasty for Infrapopliteal Artery Disease in Patients with Lower Limb Ischemia admitted to Ahwaz Golestan hospital vascular surgery ward
Public title
Impact of cilostazol on infrapopliteal angioplasty
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with Lower Limb Ischemia
age over 40 years
Exclusion criteria:
Patients with congestive heart failure
Patiets with previous lower exterimity endovascular therpy
Patients with previous lower exterimity bypass surgery
Age
From 40 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Actual sample size reached:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will divide into two groups by block randomization. Each block will be four in size and randomization is individualized by a person that is unaware of patient's group sequences.
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 Ahvaz Jundishapur university of medical sciences
Street address
Ahvaz Jundishapur university of medical sciences, Golestan st., Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
1579461357
Approval date
2019-04-13, 1398/01/24
Ethics committee reference number
IR.AJUMS.REC.1398.025
Health conditions studied
1
Description of health condition studied
Peripheral arterial disease
ICD-10 code
I73.9
ICD-10 code description
Peripheral vascular disease, unspecified
Primary outcomes
1
Description
Relief of lower extremity ischemic symptoms based on Rutherford classification
Timepoint
Documentation of lower extremity ischemic symptoms based on Rutherford classification in the beginning of trial and after 3 months of medicine consumption
Method of measurement
Measurement of severity of symptoms based on Rutherford classification
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After successful infrapopliteal angioplasty patients of this group will treat with 200 mg of cilostazol every 12 hours and 75 mg of Plavix daily for 3 months.
Category
Treatment - Drugs
2
Description
Control group: After successful infrapopliteal angioplasty patients of this group will treat 75 mg of Plavix daily for 3 months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan hospital
Full name of responsible person
Iraj Nazari
Street address
Golestan st., Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
1579461357
Phone
+98 61 3374 3002
Email
info@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Ahvaz University of Medical Sciences Vice chancellor of research
Street address
Golestan st., Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
1579461357
Phone
+98 61 3374 3002
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
Iraj Nazari
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Golestan st., Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
1579461357
Phone
+98 61 3374 3002
Email
nazari-i@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Iraj Nazari
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Golestan st., Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
1579461357
Phone
+98 61 3374 3002
Email
nazari-i@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Iraj Nazari
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Golestan st., Ahvaz, Iran
City
Ahvaz
Province
Khouzestan
Postal code
1579461357
Phone
+98 61 3374 3002
Email
nazari-i@ajums.ac.ir
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