Study of the therapeutic effect of the combination of altplas and ibtifibatide (integrilin) in comparison with altplas (r-TPA) alone, in the treatment of acute ischemic stroke
Therapeutic effect of the combination of altplas and ibtifibatide (integrilin) in comparison with altplas (r-TPA) alone, in the treatment of acute ischemic stroke
Design
Clinical trial with control group, with parallel groups, randomized, phase 2 on 50 patients. Random blocks were used for randomization.
Settings and conduct
A clinical trial study on patients with symptoms of acute ischemic stroke in the first three hours that will be performed from the beginning to the end of 1400 in Beheshti Hospital in Hamadan.In patients receiving combination drug (intervention group) and altplas (control group) at the time of arrival and discharge, the severity of stroke is assessed by the NIHSS criterion and three months later by the MRS criterion the patients' mobility is assessed.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Patients should have a serious measurable neurological defect on the NIHSS stroke scale due to focal ischemia of the brain (NIHSS score> 5),Intravenous therapy should be started within 3 hours of the onset of stroke symptoms.exclusion criteria :Suspect subarachnoid hemorrhage, even if the brain CT scan is normal.
Intervention groups
The intervention group consisted of patients receiving a combination of altplasa and ibtifibatide (integrillin) and the comparison group consisted of patients receiving altoplasia (r-TPA) alone. Next month, patients' mobility will be assessed by the MRS criterion.
Main outcome variables
Stroke severity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170117032025N9
Registration date:2021-04-07, 1400/01/18
Registration timing:prospective
Last update:2021-04-07, 1400/01/18
Update count:0
Registration date
2021-04-07, 1400/01/18
Registrant information
Name
Arash Khalili
Name of organization / entity
Hamadan University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0320
Email address
a.khalili@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-21, 1400/02/01
Expected recruitment end date
2022-03-20, 1400/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the therapeutic effect of the combination of altplas and ibtifibatide (integrilin) in comparison with altplas (r-TPA) alone, in the treatment of acute ischemic stroke
Public title
The therapeutic effect of the combination of altplas and ibtifibatide (integrilin) in comparison with altplas (r-TPA) alone, in the treatment of acute ischemic stroke
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients should have a serious measurable neurological defect on the NIHSS stroke scale due to focal ischemia of the brain (NIHSS score> 5).
Intravenous therapy should be started within 3 hours of the onset of stroke symptoms.
Exclusion criteria:
Suspect subarachnoid hemorrhage, even if the brain CT scan is normal
Age
From 18 years old to 80 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
For randomization, we use the method of block randomization with blocks with size of 4 and for this purpose, we prepare four sheets of paper. On the two sheets we write the letter I meaning "Intervention" and on the other two sheets we write the letter S meaning "Standard treatment". Mix the sheets together and place them in the desk drawer. Upon referral to any of the eligible patients, one of the sheets will be randomly pulled out and based on this sheet being drawn I or S will be assigned to one of the two intervention or comparison groups.
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 Hamadan University of Medical Sciences
Street address
Hamadan University of Medical Sciences., Shahid Fahmideh Blvd
City
Hamadan
Province
Hamadan
Postal code
6517838689
Approval date
2021-03-10, 1399/12/20
Ethics committee reference number
IR.UMSHA.REC.1399.923
Health conditions studied
1
Description of health condition studied
Acute Ischemic Stroke
ICD-10 code
G46.4
ICD-10 code description
Cerebellar stroke syndrome
Primary outcomes
1
Description
Cerebral hemorrhage
Timepoint
Admission, discharge and three months later.
Method of measurement
By NIHSS(National Institutes of Health Stroke Scale) criteria
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the group receiving the combination drug Altplase and Iftifibatide (Integrilin), Altplase ampoule is used only once and the dose of Altplase is 9 tenths of a milligram per kilogram, of which ten percent is bolus and the rest is injected within one hour. . Optifibatide ampoules are used only once, with a dose of optifibatid (integrilin) of 135 micrograms per kilogram, a bolus dose of 75 percent micrograms per kilogram per minute, and a maintenance dose for two hours.
Category
Treatment - Drugs
2
Description
Control group: In the group receiving Altplase drug, Altplase ampoule is used only once and the dose of Altplase is 9 tenths of a milligram per kilogram, of which ten percent is bolus and the rest is injected within one hour.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital, Hamadan
Full name of responsible person
Dr Mahmood Behroozi
Street address
Hamadan University of Medical Sciences., Shahid Fahmideh Blvd
City
Hamadan
Province
Hamadan
Postal code
6517838689
Phone
+98 81 3838 0535
Email
behrouzi2012@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Saeed Bashirian
Street address
Hamadan University of Medical Sciences., Shahid Fahmideh Blvd
City
Hamadan
Province
Hamadan
Postal code
6517838689
Phone
+98 81 3838 0535
Email
behrouzi2012@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Dr Mahmood Behroozi
Position
Neurology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Neuroscience
Street address
Hamadan University of Medical Sciences., Shahid Fahmideh Blvd
City
Hamadan
Province
Hamadan
Postal code
6517838689
Phone
+98 81 3838 0535
Email
behrouzi2012@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Mahmood Behroozi
Position
Neurology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Neuroscience
Street address
Hamadan University of Medical Sciences., Shahid Fahmideh Blvd
City
Hamadan
Province
Hamadan
Postal code
6517838689
Phone
+98 81 3838 0535
Email
behrouzi2012@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Mahmood Behroozi
Position
Neurology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Neuroscience
Street address
Hamadan University of Medical Sciences., Shahid Fahmideh Blvd
City
Hamadan
Province
Hamadan
Postal code
6517838689
Phone
+98 81 3838 0535
Email
behrouzi2012@gmail.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