The purpose of this study is to compare neuroprotective effects of Atorvastatin with combination of Atorvastatin and Memantine in adult patients with ischemic stroke
In this randomized, 2-armed parallel group clinical trial, 40 patients will be recruited from department of neurology, Imam Hussein hospital, Tehran, Iran. After randomization of the subject, subjects in group A will receive Atorvastatin 20mg twice daily and subjects in group B will receive Atorvastatin 20mg twice daily and Memantine 20mg three times daily for 5 days and then 20mg daily for 3 months
Primary outcome measures include:
Change in matrix metalo-proteinase 2 and -9 from baseline after 3 and 5 days of Atorvastatin compared to combination of Atorvastatin with memantine (time frame: baseline, 3 days and 5 days after intervention)
Secondary Outcome Measures:
1- Improvements from baseline scores after 5 days of Atorvastatin compared to combination of Atorvastatin with Memantine on National Institute of Health Stroke Score (time frame: baseline and 5 days after intervention)
2- Improvements from baseline scores after 5 days of Atorvastatin compared to combination of Atorvastatin with Memantine on Barthel index (time frame: baseline, 1 month and 3 months after intervention)
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012092910178N2
Registration date:2012-12-06, 1391/09/16
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-12-06, 1391/09/16
Registrant information
Name
Mohammad Sistanizad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8820 0087
Email address
sistanizadm@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2012-10-22, 1391/08/01
Expected recruitment end date
2013-03-20, 1391/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of neuroprotective effects of Memantine-Atorvastatin combination regimen with Atorvastatin in patients with ischemic stroke
Public title
Neuroprotective effects of Memantine in ischemic stroke
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: all patients with stroke
exclusion criteria: hemorrhagic stroke; sensitivity to Memantine or Statins; acute or chronic renal failure; acute or chronic hepatic disease; acute MI (<48 hours); autoimmune diseases; administration of Statin or Memantine during 6 months before stroke
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
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
Shahid Beheshti University of Medical Sciences
Street address
Velenjak Street, Shahid Chamran High Way
City
Tehran
Postal code
Approval date
2012-04-03, 1391/01/15
Ethics committee reference number
90-1-94-8104
Health conditions studied
1
Description of health condition studied
Stroke
ICD-10 code
164
ICD-10 code description
Stroke, not specified as haemorrhage or infarction
Primary outcomes
1
Description
matrix metaloproteinase 2
Timepoint
Day 1, 3, 5
Method of measurement
ELISA kits
2
Description
matrix metaloproteinase 9
Timepoint
Day 1, 3, 5
Method of measurement
ELISA kits
Secondary outcomes
1
Description
Barthel index
Timepoint
3 months after ischemic stroke
Method of measurement
Questionnaire
2
Description
motality
Timepoint
90 days after stroke
Method of measurement
check by phone
3
Description
National Institute for Health Stroke Score (NIHSS)
Timepoint
Days 1 and 5 after stroke
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention: Memantine 20 mg TID plus Atorvastatin 20 mg BID for 5 days then Memantine 10 mg BID and Atorvastatin 40 mg daily for 3 months.
Category
Treatment - Drugs
2
Description
Control: Atorvastatin 20 mg BID for first 5 days and 40 mg daily for 3 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Neurology, Imam Hussein Hospital
Full name of responsible person
Mohammad Sistanizad
Street address
Shahid Madani Street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Tahereh Shams
Street address
Velenjak Street, Shahid Chamran High Way
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Faculty of Pharmacy, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Sistanizad
Position
Assistant Professor / Clinical Pharmacy Specialist
Other areas of specialty/work
Street address
Department of Clinical Pharmacy, Faculty of Pharmacy, Niayesh Highway
City
Tehran
Postal code
Phone
+98 21 8820 0087
Fax
Email
sistanizadm@sbmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Pharmacy, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Sistanizad
Position
Assistant Professor / Clinical Pharmacy Specialist
Other areas of specialty/work
Street address
Department of Clinical Pharmacy, Faculty of Pharmacy, Niayesh Highway
City
Tehran
Postal code
Phone
+98 21 8820 0087
Fax
Email
sistanizadm@sbmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Clinical Pharmacy, Faculty of Pharmacy, Niayesh Highway
Full name of responsible person
Hamidreza Kafi
Position
Clinical Pharmacist
Other areas of specialty/work
Street address
Department of Clinical Pharmacy, Faculty of Pharmacy, Niaesh Highway
City
Tehran
Postal code
Phone
+98 21 8820 0087
Fax
Email
kafihr@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)