The aim of this study is to determine the effects of the co-administration of coenzyme Q10 supplement and statins on treatment protocols of ischemic stroke in inflammatory and outcomes level. This is a Quasi experimental study with 30 days follow-up. A total of 60 patients are enrolled in the study, non-randomized dividing into two groups (n=30) including: 1) patients with ischemic stroke, who are only receiving Atorvastatin (40 mg/day) for 30 days. 2) patients with ischemic stroke, who are receiving Atorvastatin and Coenzyme Q10 simultaneously (Q10-300 mg/day) for 30 days. A 5 cc vein blood sample will be taken from patients in admission time, 72 hours and 30 days after ischemia. GFAP protein level will be evaluated by ELIZA method. Both groups will be examined by neurologist in two phases, during admission and after 30 days for neurologic tests (NIHSS, MRS, MMSE).Inclusion criteria: patients with ischemic stroke involving the middle cerebral artery, confirmed by computed tomography scanning and clinical symptoms; range of age 50-70 years; not to receive statins continuously before entering the study; not to receive antioxidants (such as vitamin C and E) constantly; not to receive anti-inflammatory drugs (steroids, nonsteroidal anti-inflammatory) constantly. Exclusion criteria: patient's death during the study; lack of patient`s availability to follow-up; no tendency to attend in next follow-up.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017041731773N1
Registration date:2017-06-21, 1396/03/31
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-06-21, 1396/03/31
Registrant information
Name
Leila Simani
Name of organization / entity
Shahid Beheshti Medical University
Country
Iran (Islamic Republic of)
Phone
+98 21 5102 5582
Email address
l.simani90@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2017-04-21, 1396/02/01
Expected recruitment end date
2017-10-23, 1396/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the protective effects of Atorvastatin compared with Atorvastatin- Coenzyme Q10 co-administration on level of GFAP in patients with stroke
Public title
Effect of Atorvastatin and CoQ10 on stroke
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: (patients with ischemic stroke involving the middle cerebral artery, confirmed by computed tomography scanning and clinical symptoms; range of age 50-70 years; not to receive statins continuously before entering the study; not to receive antioxidants (such as vitamin C and E) constantly; not to receive anti-inflammatory drugs (steroids, nonsteroidal anti-inflammatory) constantly; not affected by AIDS and neurodegenerative diseases (e.g. Alzheimer's, Parkinson's, amyotrophic lateral sclerosis, multiple sclerosis); no loss of consciousness level due to any reason except stroke (such as shock, alcohol consumption or intoxication); non-pregnancy; non-epilepsy; patient`s consent).Exclusion criteria: (patient's death during the study; lack of patient`s availability to follow-up; no tendency to attend in next follow-up).
Age
From 50 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
This is a Quasi experimental pilote study with 30 days follow-up. A total of 60 patients are enrolled in the study, non-randomized dividing into two groups (n=30) according to admitiion days. Even days for Atorvastatin and Odd days for Atorvastatin and CoQ10 will be allocated.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences, Daneshjo blv., Evin
City
Tehran
Postal code
Approval date
2017-02-19, 1395/12/01
Ethics committee reference number
IR.SBMU.PHNM.1395.616
Health conditions studied
1
Description of health condition studied
ischemic stroke
ICD-10 code
I63
ICD-10 code description
Cerebral infarction
Primary outcomes
1
Description
Degree of disability
Timepoint
Admission- After 30 day
Method of measurement
Modified Rankin Scale (MRS)
2
Description
Glial fibrillary acidic protein(GFAP)
Timepoint
admission- 72 houre-after 30 day
Method of measurement
eliza kit
3
Description
Cognitive performance
Timepoint
admission- 72 houre-after 30 day
Method of measurement
Mini-Mental State Examination(MMSE)
4
Description
Motor function and verbal
Timepoint
admission- 72 houre-after 30 day
Method of measurement
National Institutes of Health Stroke Scale(NIHSS)
Secondary outcomes
empty
Intervention groups
1
Description
Atorvastatin = 40 mg/day.oral, Coadministration with CoQ10= 300 mg/day
Three times a day. 30 days. oral.
Category
Treatment - Drugs
2
Description
Atorvastatin= 40 mg/day,daily
30 days, oral
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Loghman Hakim Educational Hospital
Full name of responsible person
Leila Simani
Street address
Loghman Hakim Educational Hospital, South Kargar Ave., Kamali St., Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zahra Sahraei
Street address
Shahid Beheshti University of Medical Sciences, Shahid Erabi St., Yaman St., Shahid Chamran Highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Leila Simani
Position
PhD Neuroscince
Other areas of specialty/work
Street address
Loghman Hakim Educational Hospital, Kamali St., South Kargar Ave.
City
Tehran
Postal code
Phone
+98 21 5102 5582
Fax
+98 21 5541 6130
Email
l.simani90@sbmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Loghman Hakim Educational Hospital
Full name of responsible person
Zahra Sahraei
Position
Pharmacotherapy
Other areas of specialty/work
Street address
Loghman Hakim Educational Hospital, Kamali St, South Kargar Ave
City
Tehran
Postal code
1333635445
Phone
+98 21 5102 5582
Fax
+98 982155416130
Email
l.simani90@sbmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Loghman Hakim Medical Center
Full name of responsible person
Leila Simani
Position
PhD Neurosicence
Other areas of specialty/work
Street address
Loghman Hakim Medical Center, Kamali St, South Kargar Ave,
City
Tehran
Postal code
1333635445
Phone
+98 21 5102 5182
Fax
+98 21 5541 6130
Email
l.simani62@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)