The study goal is Evaluation of the neuroprotective effect of N-Acetyl-Cysteine in patients with cerebrovascular accident in years 95-96 in firoozgar hospital. it is a single blind placebo controlled trial.
Population study is patients admitted to stroke unit of firoozgar hospital. The main inclusion criteria are patients with mild to moderate first attack of CVA admitted within 24 hours of symptom onset. The main exclusion criteria are allergy to N- acetyl- cysteine, severe hepatic or renal failure and patients who received r-tPA. Study sample size which is sum of both control and treatment group is 60 patients. N- acetyl- cysteine is given to treatment group in addition to standard CVA treatment. Patients in control group only received standard CVA treatment. Intervention time is first 24 hours of CVA onset. The blood sample for measuring MMP-9 marker is collected from both groups before and 24 hours after receiving N- acetyl- cysteine and standard treatment. NIHSS for the patients in both group is calculated before therapy, 24 hours, 2 weeks, 1 months and 3 months after therapy.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017011931229N2
Registration date:2017-02-24, 1395/12/06
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-02-24, 1395/12/06
Registrant information
Name
Azadeh Eshraghi
Name of organization / entity
Department of Clinical Pharmacy, Faculty of Pharmacy-International Campus, Iran University of Medica
Country
Iran (Islamic Republic of)
Phone
+98 86709
Email address
eshraghi.a@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2016-03-19, 1394/12/29
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
Evaluation of the neuroprotective effect of N-Acetyl-Cysteine in patients with cerebrovascular accident in years 95-96 in firoozgar hospital.
Public title
N- acetyl- cysteine effect in stroke treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: all admitted patients with first attack of mild to moderate CVA according to NIHSS between 0-16; admitted patients within first 24 hours of onset of CVA.
Exclusion criteria:Hemorrhagic stroke; Severe Hepatic or renal failure. ( creatinine clearance less than 30 mg/dl); History of Vasculitis; Allergy to N- acetyl- cystein; Alzheimer or dementia due to any cause; Coexistent other neurologic disorders.;Past history of CVA;Age more than 80 years; Diseases that affect on MMP-9 level. e.g neuropsychiatric disorders like schizophrenia and bipolar disorder,epilepsy and mutiple sclerosis; Intravenous or intaarterial r-tPA injection.
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran Uinversity of Medical Sciences
Street address
Tehran- hemmat highway- near milad tower- iran university of medical sciences
City
Tehran
Postal code
1449614535
Approval date
2016-09-22, 1395/07/01
Ethics committee reference number
IR.IUMS.REC.1395.28001
Health conditions studied
1
Description of health condition studied
Stroke
ICD-10 code
G46
ICD-10 code description
Vascular syndromes of brain in cerebrovascular disease
Primary outcomes
1
Description
MMP9
Timepoint
Before and 24 hours after intervention
Method of measurement
ELISA kit
2
Description
NIHSS
Timepoint
Before intervention, 24 hours, 2 weeks, 1 month and 3 months after intervention
Method of measurement
Standard scale
Secondary outcomes
1
Description
Side effects
Timepoint
24 hours after treatment
Method of measurement
Clinic
Intervention groups
1
Description
Intervention:
1. Amp N- acetyl- cysteine 100 mg/kg stat in the onset of stroke then 10 mg/kg/hour IV infusion for 10 hours.
Category
Treatment - Drugs
2
Description
Intervention:
2. Tab ASA 325 mg PO daily for 14 days then 80 mg PO daily lifelong
Category
Treatment - Drugs
3
Description
Intervention:
3. Tab plavix 325 mg PO stat then 75 mg daily for 90 days
Category
Treatment - Drugs
4
Description
Control:
2. Tab plavix 325 mg PO stat then 75 mg daily for 90 days
Category
Treatment - Drugs
5
Description
Control:
1. Tab ASA 325 mg PO daily for 14 days then 80 mg PO daily lifelong
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Firoozgar hospital
Full name of responsible person
Rezan Ashayeri
Street address
Region 6- Valiasr Square- beh Afarin street.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Zahra Ebrahimi Monazzam
Street address
Hemmat highway- near to Mild tower
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Rezan ashayeri
Position
Neurology Resident
Other areas of specialty/work
Street address
Region 6- Valiasr square- Beh Afarin- firoozgar hospital