A comparative study of the effects of tissue plasminogen activator and dual antiplatelet therapy on improvement of the score of the National Institutes of Health Stroke Scale in acute ischemic stroke treatment
This study compares the effects of tissue plasminogen activator and dual antiplatelet therapy on improvement of National Institutes of Health Stroke Scale (NIHSS) scores in acute ischemic stroke treatment. A total of 60 patients with inclusion criteria will be recruited via convenience sampling method. Major inclusion criteria: proved ischemic stroke; initiation of stroke symptoms within 4.5 hours from admission; clinical NIHSS score between four and 18. Major exclusion criterion: age 80 years old, brain hemorrhage on initial computerized tomography scan, and current treatment with oral anticoagulants. The study is double-blind, one-centered, and prospective. The patients will be allocated into case (30 patients) and control group (30 patients) via randomized blocked allocation method (i.e., 1:1). The cases will receive tissue plasminogen activator (Retavase®) 0.9 milligram per kilogram (maximum doses: 90 milligram) where 10 percent of the total dose is administered as a 10 U bolus dose followed by a 60-minute infusion of the remaining doses. The controls will receive dual antiplatelet therapy by daily aspirin 80 milligrams and clopidogrel 75 milligrams for three months. Then, the clopidogrel will be discontinued. Clinical response in both groups will be assessed using NIHSS at the initial presentation, after 24 and 48 hours, and at discharge from hospital.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2017082117756N24
Registration date:2017-09-10, 1396/06/19
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-09-10, 1396/06/19
Registrant information
Name
Mohammad Bagher Roozgar
Name of organization / entity
Birjand University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 3239 5680
Email address
mbroozgar@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research of Birjand University of Medical Sciences
Expected recruitment start date
2017-03-21, 1396/01/01
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of the effects of tissue plasminogen activator and dual antiplatelet therapy on improvement of the score of the National Institutes of Health Stroke Scale in acute ischemic stroke treatment
Public title
Effects of tissue plasminogen activator and dual antiplatelet therapy in acute ischemic stroke treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Proved ischemic stroke; informed consent for participation; stroke symptoms initiated within 4.5 hours before admission; no brain hemorrhage on initial computerized tomography scan; clinical national institutes of health stroke scale between 4 and 18.
Exclusion criteria: Age 80 years or above; brain hemorrhage in initial computerized tomography scan; history of stroke; history of diabetes mellitus; patients currently receiving oral anticoagulant treatment without considering the international normalized ratio; clinical national institutes of health stroke scale above 25; large ischemic changes of brain or involvement of more than one-third of middle cerebral artery supplying zone in the initial computerized tomography scan.
Age
To 80 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
This is a double-blind study and both the physician and the patient are unaware of the study groups. Moreover, the participants will be selected via convenience sampling method and assigned into intervention and control groups via randomized blocked allocation method (i.e., 1:1).
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Birjand University of Medical Sciences
Street address
Vice-chancellery of Research, Birjand University of Medical Sciences, Ghaffari St.,
City
Birjand,
Postal code
Approval date
2016-08-18, 1395/05/28
Ethics committee reference number
Ir.bums.REC.1395.171
Health conditions studied
1
Description of health condition studied
acute ischemic stroke
ICD-10 code
I63.9
ICD-10 code description
cerebrovascular (embolic) (ischemic) (thrombotic)
Primary outcomes
1
Description
National Institutes of Health Stroke Scale score
Timepoint
at the initial presentation, after 24 and 48 hours, and at discharge from hospital
Method of measurement
Physical examination
Secondary outcomes
1
Description
Complications of tissue plasminogen activator treatment
Timepoint
after 24 and 48 hours from the initiation of treatment and at discharge from hospital
Method of measurement
brain computerized tomography scan
Intervention groups
1
Description
Intervention Group (tissue plasminogen activator ): The cases receive tissue plasminogen activator (Retavase®) 0.9 milligram per kilogram (maximum doses: 90 milligram) where 10 percent of the total dose is administered as a 10 U bolus dose followed by a 60-minute infusion of the remaining doses. Clinical response will be assessed at the initial presentation, after 24 and 48 hours, and at discharge from hospital by national institutes of health stroke scale. Decrease in score of national institutes of health stroke scale will be considered as the sign of improvement.
Category
Treatment - Drugs
2
Description
Control Group (dual antiplatelet therapy): The controls receive dual antiplatelet therapy by daily aspirin 80 milligram and clopidogrel 75 milligram for three months. After three months, the clopidogrel will be discontinued. Clinical response will be assessed at the first presentation, after 24 and 48 hours and at discharge from hospital by national institutes of health stroke scale. Decrease in score of national institutes of health stroke scale will be considered as the sign of improvement.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr Hospital
Full name of responsible person
Dr. Elham Zarei
Street address
Neurology Ward, Valiasr Hospital, Ghaffari St.,
City
Birjand,
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellery of Research, Birjand University of Medical Sciences
Full name of responsible person
Dr. Tooba Kazemi
Street address
Vice-chancellery of Reasearch and Technology, Birjand University of Medical Sciences, Ghaffari St.,
City
Birjand,
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellery of Research, Birjand University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr. Elham Zarei
Position
Doctor of Medicine
Other areas of specialty/work
Street address
Faculty of Medicine, Birjand University of Medical Sciences, Ghaffari St.,
City
Birjand,
Postal code
Phone
+98 56 3222 5402
Fax
Email
dr.elizarei@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr. Hamidreza Riasi
Position
Neurologist
Other areas of specialty/work
Street address
Neurology Ward, Valiasr Hospital, Ghaffari St.,
City
Birjand,
Postal code
Phone
+98 56 3242 5402
Fax
Email
riasi_h@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Mohammad Bagher Roozgar
Position
PhD Candidate in Translation Studies
Other areas of specialty/work
Street address
Vice-chancellery of Education, Birjand University of Medical Sciences, Ghaffari St.,
City
Birjand,
Postal code
Phone
+98 56 3239 5680
Fax
Email
hadirooz@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)